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Drug Safety and Information

SIDE EFFECTS: FULL DISCLOSURE AND NOTICE

Drugs and medications may have potential side effects. This section provides the user with notice about the known side effects of the medications used in the compounding formulas offered by Happy Head. This is not a complete list and there may be additional side effects in the literature that may not be covered in this section.

BY USING HAPPY HEAD, USERS AGREE THAT IN NO EVENT SHALL HAPPY HEAD, INC., ITS OFFICERS, DIRECTORS, EMPLOYEES, HEALTH COUNSELORS, INDEPENDENT CONTRACTORS OR STAFF PHYSICIANS OR AGENTS, BE LIABLE TO YOU FOR ANY DIRECT (INCLUDING DEATH), PSYCHOLOGICAL, EMOTIONAL, INDIRECT, INCIDENTAL, FINANCIAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES WHATSOEVER RESULTING FROM (1) THE PURCHASE AND USE OF PRODUCTS SOLD ON OUR WEBSITE, (2) ANY SIDE EFFECTS THAT THESE MEDICATIONS MAY HAVE EITHER ALONE BY THEMSELVES OR COMPOUNDED TOGETHER IN A FORMULA. IF YOU ARE WORRIED ABOUT THE SIDE EFFECTS OF THESE MEDICATIONS, PLEASE DO NOT USE HAPPY HEAD. BY AGREEING TO PURCHASE AND USE HAPPY HEAD, YOU HAVE UNDERSTOOD AND AGREED TO THE SIDE EFFECTS STATED BELOW AND UNDERSTAND THAT ANY OF THESE SIDE EFFECTS MAY OCCUR, AND BE EITHER TEMPORARY OR PERMANENT. YOU ALSO AGREE THAT THERE MAY BE SIDE EFFECTS NOT LISTED AND THIS IS NOT A COMPLETE LIST OF SIDE EFFECTS.

We do not take any responsibility for the safety or efficacy of any of the products sold through this website, nor for any possible side effects that may result due to the use of these products. By viewing this Drug Safety & Information page, you confirm that you have provided accurate medical history and correctly informed your prescribing physician of all ongoing medical conditions, risk factors, medications, and/or allergies and that you have been examined by a physician to confirm your health status prior your telemedicine visit. It is highly encouraged for consumers to ask their personal physicians about the safety and efficacy of such products before use. None of the products sold on this website are intended to treat, prevent, cure, relieve, resolve, or stop any type of medical condition. Compound prescription products have not been tested or approved by the FDA for their intended use. This product may burn the skin, temporarily or permanently and may cause permanent scarring alopecia. The information provided by our healthcare counselors does not replace talking with your primary care physician regarding your medical conditions and your treatment with oral or topical compounded formulations containing Finasteride, Dutasteride, Minoxidil, Spironolactone, Latanoprost, Retinoic Acid, and/or Hydrocortisone. Please read all this information before you start taking any of our prescribed formulations and please reread this every time you get a new refill, as the information may change and there may be updated, new information provided.

FINASTERIDE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Read this section before you start taking Finasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Finasteride has been FDA approved for use in men for androgenetic alopecia in the oral form, all other formulations are off-label. For full transparency, side effects of Finasteride include but not limited to hypersensitivity reaction (allergic reaction), angioedema, prostate cancer (high-grade), breast cancer, male infertility, impotence, loss in sexual ability, sexual desire, sexual drive, or performance, decrease libido, hypotension, abnormal ejaculation, any form of sexual dysfunction described or not described here, impotence, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, decrease volume of ejaculate, tenderness in genital organs, testicular pain or numbness, infertility, poor seminal quality, poor sperm mobility, penile curviture changes, gynecomastia (enlarge breast tissue), breast tenderness, swelling tingling burning or pain in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, hair loss (temporary or permanent), change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, brain fog, fogginess of the head, short-term and long-term memory loss, terrible fatigue, trouble concentrating, increasingly moody, depression, mood swings, mood changes, runny nose, sleepiness or unusual drowsiness, slurred speech, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, death, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, breast cancer in males and females, any other cancer in males and females, depression, lower testosterone, complete loss of testosterone, shrinkage of sexual organs, change in sexual orientation and any side effect contributed to what is now called post-finasteride syndrome and listed on the website: www.pfsfoundation.org/about-pfs-post-finasteride-syndrome/. All sexual side effects may be long-term (permanent).

Patients must not share the medication with any female. Finasteride is not FDA approved for use in women, but may be used off-label to treat hair loss in women over 50 in some circumstances. Finasteride is a Category X (teratogenic) medication due to its potential to cause birth defects in male fetuses. Pregnant women and children should not use or come into direct skin contact with Finasteride. The effectiveness of Finasteride for hair loss in women as well as the potential risks/side effects are not well understood because large scale clinical trials have not been done in this population. When used off-label to treat hair loss in women, small studies have indicated that women experience similar side effects to men taking Finasteride (as listed above). Women may additionally experience dry skin, acne, headaches, irregular menses, increased body hair, headache, dizziness, fatigue, weight gain, elevated liver enzyme, edema. There have been reports of breast cancer in men who have taken oral Finasteride and it is unknown how this risk may translate to women.

The above is not a complete list of all side effects or studies conducted. User agrees and understands that there may also be other side effects that may occur that have not been reported, discovered or listed in the literature yet and may have been reported but not listed here. This list is intended to give full transparency about the possibility of most or all of the side effects of Finasteride, some of which may be long term and permanent. User understands and agrees that they have been fully informed about the above side effects. Our goal is to empower our patients to make educated decisions about their treatment choices. We are incorporating the following drug PDR in this section as a reference: https://www.pdr.net/drug-summary/Propecia-finasteride-378.609. Also, on 6/9/2011, FDA released a drug safety communication detailing the long-term side effects of Finasteride and it is referenced here at the following link: https://www.pdr.net/fda-drug-safety-communication/propecia?druglabelid=378&id=8965. In patients taking Finasteride, there is an increased risk of the more advanced stage of (high grade) prostate cancer or serious prostate cancer. In rare cases, male breast cancer has also been reported.

Finasteride & PSA (Prostate Specific Antigen): PSA test is a screening blood test performed by your physician to check for prostate cancer. Finasteride has been shown to reduce the PSA level, sometimes as much as 50%. The significance of this is as follows. Reduction in PSA can mask underlying prostate cancer. When you have a PSA test done, it is imperative that you tell your physician that you are taking Finasteride in order to better assess the real PSA value of your blood test. Any changes from your baseline PSA can indicate a possible prostate cancer, even if your levels are within normal limits. You should always tell your physician if you are or are not taking Finasteride, as this will impact the actual interpretation of your PSA level.The American Academy of Family Physicians and the Canadian Task Force on Preventive Health Care recommend against PSA-based screening for prostate cancer. The American College of Physicians recommends that clinicians discuss the benefits and harms of screening with men aged 50 to 69 years and only recommends screening for men who prioritize screening and have a life expectancy of more than 10 to 15 years.

The American Urological Association recommends that men aged 55 to 69 years with a life expectancy of more than 10 to 15 years be informed of the benefits and harms of screening and engage in shared decision making with their clinicians, taking into account each man’s values and preferences. It notes that to reduce the harms of screening, the screening interval should be 2 or more years. The American Urological Association also notes that decisions about screening, including potentially starting screening before age 55 years, should be individual ones for African American men and men with a family history of prostate cancer. The American Cancer Society adopted detailed screening recommendations in 2016 that highlight the importance of shared decision making and the need for informed discussion of the uncertainties, risks, and potential benefits of screening. It recommends conversations about screening beginning at age 50 years and earlier for African American men and men with a father or brother with a history of prostate cancer before age 65 years.

PREGNANCY WARNING: Females who are pregnant or who may become pregnant should not come in contact with Finasteride. Finasteride may harm your unborn baby. If a woman who is pregnant or a child comes in contact with a Finasteride solution or crushed pills, please wash the area right away with soap and water and contact your healthcare provider. If a pregnant woman with a male baby fetus swallows or comes in contact with Finasteride, the male baby may be born with sex organs that are not normal. Finasteride may also affect sperm counts/quality and can be secreted in the sperm in very low amounts, but currently there are no recommendations based on data from clinical trials to suggest that men should avoid taking Finasteride during conception or while a partner is pregnant.

DUTASTERIDE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Read this section before you start taking Dutasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Dutasteride has been FDA approved for use in men for benign prostatic hyperplasia in the oral form, all other formulations are off-label. For full transparency, side effects of Dutasteride include but not limited to hypersensitivity reaction (allergic reaction), angioedema, prostate cancer (high-grade), breast cancer, male infertility, Impotence, loss in sexual ability, desire, drive, or performance, decrease libido, hypotension, abnormal ejaculation, depression, anxiety, sexual dysfunction, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, penile fibrosis, penile scarring, decrease volume of ejaculate, tenderness in genital organs, testicular pain, infertility, poor seminal quality, poor sperm mobility, gynecomastia (enlarge breast tissue), swelling in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, hair loss (temporary or permanent), change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, runny nose, sleepiness or unusual drowsiness, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, breast cancer in males and females, depression, lower testosterone, and shrinkage of sexual organs. All sexual side effects may be long-term (permanent). Impotence, loss in sexual ability, desire, drive, or performance, decrease libido, hypotension, abnormal ejaculation, sexual dysfunction, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, decrease volume of ejaculate, tenderness in genital organs, testicular pain, infertility, poor seminal quality, testicular pain, testicular numbness, poor sperm mobility, gynecomastia (enlarge breast tissue), swelling in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, brain fog, fogginess of the head, short-term and long-term memory loss, terrible fatigue, trouble concentrating, increasingly moody, depression, runny nose, sleepiness or unusual drowsiness, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, , depression, lower testosterone, complete loss of testosterone, breast cancer, heart failure, atrial fibrillation, teratogenesis, visual impairment, exfoliative dermatitis, Stevens-Johnson syndrome, angioedema, erythema multiforme, ejaculation dysfunction, impotence (erectile dysfunction), orthostatic hypotension, priapism, testicular swelling, hypotension, palpitations, dyspnea, chest pain (unspecified), blurred vision, floppy iris syndrome, edema, constipation, depression, libido decrease, dizziness, vertigo, syncope, diarrhea, sinusitis, cough, rhinitis, back pain, asthenia, pharyngitis, insomnia, infection, drowsiness, testicular pain, orgasm dysfunction, decreased ejaculate volume, breast enlargement, gynecomastia, rash, urticaria, pruritus, vomiting, xerostomia, epistaxis, oligospermia, spermatogenesis inhibition. Although Dutasteride is not the same as Finasteride, possibility of post-dutasteride syndrome may still exist and will cite the post-finasteride syndrome as a reference as a possibility of side effects. Post-finasteride syndrome: www.pfsfoundation.org/about-pfs-post-finasteride-syndrome/, and shrinkage of sexual organs. All sexual side effects may be long-term (permanent).

Patients must not share the medication with any female. Dutasteride is not FDA approved for use in women but may be used off-label to treat hair loss in women under some circumstances. Dutasteride is a Category X (teratogenic) medication due to the potential to cause birth defects in male fetuses. Pregnant women and children should not use or come into direct skin contact with Dutasteride. The effectiveness of Dutasteride for hair loss in women as well as the potential risks/side effects are not well understood because large scale clinical trials have not been done in this population. When used off-label to treat hair loss in women, small studies have indicated that women experience similar side effects to men taking Dutasteride (as listed above). Women may additionally experience dry skin, acne, headaches, irregular menses, increased body hair, headache, dizziness, fatigue, weight gain, elevated liver enzyme, and edema. There have been reports of breast cancer in men who have taken oral Finasteride and it is unknown how this risk may translate to women taking Dutasteride.

There may also be other side effects that may occur that have not been listed. This is intended to give full transparency about the possibility of the side effects of Dutasteride, some of which may be long term, and that you are fully informed about the above side effects. Our goal is to empower our patients to make educated decisions about their treatment choices. The above is not a complete list of all side effects or studies conducted. With respect to labs, you are responsible for checking your PSA levels with your own primary care physician.

Do not use Dutasteride if you have orthostatic hypotension, vertigo, or syncope. Dutasteride is not intended for use in neonates, infants, children, and adolescents under 18 years of age. Safety and effectiveness have not been established in this age group. Patients receiving or who have previously received treatment with Dutasteride or other alpha-1 blockers may be at risk for intraoperative floppy iris syndrome during surgery for cataracts (ocular surgery). Dutasteride is a non-arylamine sulfonamide derivative. In patients with sulfonamide hypersensitivity, allergic reaction to tamsulosin has been rarely reported. If a patient reports a serious or life threatening sulfonamide allergy, the manufacturer advises caution when administering Dutasteride. Rarely (probably less than 1 in 50,000) like other alpha adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Dutasteride should be used with caution in patients with hepatic disease. Pregnant women or women trying to conceive or women who are breastfeeding should not handle Dutasteride. Dutasteride is not indicated for use in females, and the use of this product during pregnancy is contraindicated. Infertility, decreased semen production or any fertility issue may be associated with use of Dutasteride.

Dutasteride & PSA (Prostate Specific Antigen): PSA test is a screening blood test performed by your physician to check for prostate cancer. Dutasteride has been shown to reduce the PSA level, sometimes as much as 50%. The significance of this is as follows. Reduction in PSA can mask underlying prostate cancer. When you have a PSA test done, it is imperative that you tell your physician that you are taking Dutasteride in order to better assess the real PSA value of your blood test. Any changes from your baseline PSA can indicate a possible prostate cancer, even if your levels are within normal limits. You should always tell your physician if you are or are not taking Dutasteride, as this will impact the actual interpretation of your PSA level.

The American Academy of Family Physicians and the Canadian Task Force on Preventive Health Care recommend against PSA-based screening for prostate cancer. The American College of Physicians recommends that clinicians discuss the benefits and harms of screening with men aged 50 to 69 years and only recommends screening for men who prioritize screening and have a life expectancy of more than 10 to 15 years. The American Urological Association recommends that men aged 55 to 69 years with a life expectancy of more than 10 to 15 years be informed of the benefits and harms of screening and engage in shared decision making with their clinicians, taking into account each man’s values and preferences. It notes that to reduce the harms of screening, the screening interval should be 2 or more years. The American Urological Association also notes that decisions about screening, including potentially starting screening before age 55 years, should be individual ones for African American men and men with a family history of prostate cancer. The American Cancer Society adopted detailed screening recommendations in 2016 that highlight the importance of shared decision making and the need for informed discussion of the uncertainties, risks, and potential benefits of screening. It recommends conversations about screening beginning at age 50 years and earlier for African American men and men with a father or brother with a history of prostate cancer before age 65 years.

Again, Dutasteride can have rare and uncommon side effects that you should be aware of. This includes sexual side effects (such as decreased libido, erectile dysfunction), psychological side effects (such as depression or anxiety) and similar side effects to the post-finasteride syndrome. If these side effects do occur, even if mild, please report them to your doctor immediately and stop taking the medication. There is an increased risk of the more advanced stage of (high grade) prostate cancer or serious prostate cancer. In rare cases, male breast cancer has also been reported. Oral Dutasteride is an FDA approved medication used to treat enlarged prostate and has been used off-label for treating male pattern hair loss. Compounded medications are not approved by the FDA. Topical version of the Dutasteride has not been tested/approved by the FDA. The combination of Dutasteride, Minoxidil, Retinoic Acid and/or Hydrocortisone is a compounded prescription medication prescribed by your doctor and not tested/approved by the FDA.

PREGNANCY WARNING: Females who are pregnant or who may become pregnant should not come in contact with Dutasteride. Dutasteride may harm your unborn baby. If a woman who is pregnant or a child comes in contact with Dutasteride solution or crushed pills, please wash the area right away with soap and water and contact your healthcare provider. If a pregnant woman with a male baby fetus swallows or comes in contact with Dutasteride, the male baby may be born with sex organs that are not normal. Dutasteride may also affect sperm counts/quality and can be secreted in the sperm in very low amounts, but currently there are no recommendations based on data from clinical trials to suggest that men should avoid taking Dutasteride during conception or while a partner is pregnant.

MINOXIDIL SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Before you start using Minoxidil and each time you get a refill, please review this section. This information does not replace discussing your medical condition or treatment with your healthcare provider.

Topical Minoxidil is FDA approved as a treatment for hair loss in men and women as a 2% and 5% topical formulation. All other topical compounded strengths of Minoxidil are considered off-label for hair loss treatment. Oral Minoxidil is FDA approved for symptomatic high blood pressure that is not controlled by a diuretic plus two other blood pressure lowering drugs. Your provider may recommend a low dose of oral Minoxidil as an off-label treatment for hair loss.

Contraindications: You should not use Minoxidil if you are allergic to it, or if you have a pheochromocytoma (tumor of the adrenal gland).

Black Box Warning for Serious Cardiac Effects

  • Oral Minoxidil has a black box warning because the medication is a powerful antihypertensive agent and can produce serious adverse effects. Note that serious cardiovascular side effects from oral Minoxidil have been demonstrated in clinical trials evaluating patients with symptomatic high blood pressure that was not controlled by a diuretic plus two other blood pressure lowering drugs and using oral Minoxidil at doses of 5mg or higher. When used off-label for hair loss, oral Minoxidil is dosed at less than 5mg in an attempt to avoid blood pressure lowering effects and reduce adverse cardiovascular effects.
  • Minoxidil can cause pericardial effusion, the accumulation of too much fluid in the sac that surrounds the heart (pericardium). Pericardial effusion can progress to a condition called tamponade which increases pressure on the heart and keeps it from beating properly. This can result in sharp chest pain and difficulty breathing. Seek emergency treatment if this occurs.
  • When using Minoxidil to treat high blood pressure, it should be reserved for patients who do not respond adequately to maximum therapeutic doses of a diuretic (water pill) and two other blood pressure lowering drugs. It must be administered under close supervision, usually along with a beta-blocking agent to prevent increased heart rate (tachycardia) and increased the stress put on the heart muscle (myocardial workload). It must also usually be given with a diuretic to prevent serious fluid accumulation.
  • Chest pain warning: Minoxidil can increase your heart rate and cause or worsen chest pain (angina). Doctors usually prescribe a beta-adrenergic blocking drug with Minoxidil to avoid this. If you have new or worsening pain in the chest, arm, or shoulders, tell your doctor right away.
  • Heart function warning: Minoxidil can cause poor heart function or worsen existing heart problems like heart failure. When tested on animals, Minoxidil caused several kinds of lesions of the heart muscle as well as other adverse heart effects. Patients with malignant hypertension and those already receiving guanethidine should be hospitalized when Minoxidil is first administered so that they can be monitored to avoid too rapid or large decreases in blood pressure.


Comorbidities/Precautions:

  • Minoxidil should be used with caution in patients with heart conditions or cardiovascular disease or at high risk for these (including conditions like stroke, heart attack, or congestive heart failure) and liver or kidney disease. It is recommended that you obtain clearance from your cardiologist and primary care doctor prior to beginning oral Minoxidil for hair loss therapy. Ensure you disclose your entire medical history to your healthcare provider. Be aware that withholding or providing inaccurate health and medical history to obtain treatment can have serious consequences, potentially including death.
  • Do not use topical Minoxidil if you have active skin abrasion or irritations, such as excoriations, open wounds, psoriasis, or sunburn. This can increase your risk for skin irritation and systemic absorption of topically administered Minoxidil. The topical formulation is meant for external use only and should not be ingested or applied to other body parts.

Pregnancy and Special Populations: Minoxidil is pregnancy category C, indicating that its safety in pregnant women has not been fully established. Animal studies have shown risk to the fetus, but there are no controlled studies in women. It should be avoided by women who are pregnant, planning pregnancy, or breastfeeding.

The safety and efficacy of topical Minoxidil products have not been established in children and adolescents. Children should not take or come in contact with Minoxidil. Minoxidil can be toxic to some animals, so do not let your pets come into contact with it or lick your hands after application.

Drug-interactions: Minoxidil may interact with other medications, especially those that affect blood pressure or heart function. Guanethidine should not be taken with Minoxidil. Always inform your healthcare provider of all the medications you are currently taking. You may need to limit or reduce the salt in your diet while taking Minoxidil. Do not use potassium supplements or salt substitutes, unless your doctor has told you to. Do not take Minoxidil with sildenafil or tadalafil.

Common side effects for topical Minoxidil:

  • Initial shedding or increased hair loss in the first weeks of use.
  • Itchy scalp or skin rash.
  • Dryness, scaling, or flakiness of the scalp.
  • Redness or irritation at the application site.
  • Unwanted facial or body hair growth, especially in women.
  • Dizziness or light-headedness.
  • Rapid or irregular heartbeat.
  • Chest pain or palpitations.
  • Swelling of hands, feet, or face.
  • Difficulty breathing when lying down.
  • Weight gain due to fluid retention.

The most serious side effects of oral Minoxidil are reviewed below. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes:

Salt and water retention: Monitor for fluid retention and increase in body weight. If you quickly gain five or more pounds, or if there is any swelling or puffiness in the face, hands, ankles, or stomach area, this could be a sign that you are retaining body fluids. Contact your provider immediately.

Increased heart rate (tachycardia): Oral Minoxidil can increase your heart rate. Chest pain/angina may worsen or appear for the first time during oral Minoxidil therapy, likely due to the increased oxygen demands associated with increased heart rate and cardiac output. You should measure your heart rate by counting your pulse rate while you are resting. If you have an increase of 20 beats or more a minute over your normal pulse or experience new/worsening chest pain, contact your provider immediately or seek urgent care.

Pericarditis, Pericardial Effusion and Tamponade: Oral Minoxidil can cause an accumulation of fluids in the sac surrounding the heart. Monitor for sharp pain in the chest, arm, or shoulder; signs of severe indigestion; or shortness of breath, dizziness, lightheadedness, and fainting. These could be signs of serious heart problems and you should seek immediate emergency care.

Hazard of Rapid Control of Blood Pressure: A sudden or too large of a drop in blood pressure can lead to fainting, heart attack, and loss of blood flow to certain organs. These are signs of serious heart problems and you should seek immediate emergency care. You should monitor your blood pressure closely when starting oral Minoxidil or changing dosing.

If you experience severe symptoms or are having a medical emergency, call 911 or seek immediate medical attention.

The above does not encompass all potential side effects, medication interactions, or studies related to Minoxidil. Unreported or yet undiscovered side effects might exist. Please review the FDA prescribing information and the Prescriber’s Digital Reference (PDR) for a comprehensive overview of Minoxidil:

When considering Minoxidil therapy for hair loss in the topical or oral form, it’s essential to weigh the potential benefits against the potential risks. Always discuss any concerns, symptoms, or side effects with your healthcare provider. Lastly, every individual may respond differently to medications. It’s essential to stay informed and regularly consult with healthcare professionals to ensure the therapy remains suitable for you.

RETINOIC ACID (TRETINOIN) SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Side effects may include: GI bleeding, disseminated intravascular coagulation (DIC), arrhythmia exacerbation, pleural effusion, visual impairment, increased intracranial pressure, intracranial bleeding, heart failure, hearing loss, pulmonary edema, laryngeal edema, peptic ulcer, cardiomyopathy, pericarditis, pulmonary hypertension, myocarditis, myocardial infarction, cardiac arrest, stroke, agnosia, seizures, coma, renal failure (unspecified), renal tubular necrosis, erythema nodosum, differentiation syndrome, pericardial effusion, hypervitaminosis A, pancreatitis, thrombosis, papilledema, spontaneous fetal abortion, teratogenesis, bone pain, dyspnea, elevated hepatic, enzymes, hyperlipidemia, bleeding, fluid retention, peripheral edema, stomatitis, constipation, wheezing, hypotension, depression, phlebitis, hypertension, confusion, flank pain, hepatomegaly, splenomegaly, dysuria, edema, hallucinations, ascites, hepatitis, impaired, cognition, ataxia, dysarthria, aphasia, encephalopathy, thrombocytosis, erythema, hypoxia, respiratory depression, pseudotumor cerebri, hypertriglyceridemia, hypercholesterolemia, hypercalcemia, headache, fever, fatigue, malaise, shivering, vomiting, nausea, rash, leukocytosis, abdominal pain,, weight gain, diarrhea, flushing, otalgia, dizziness, diaphoresis, anorexia, weight loss, anxiety, paresthesias, alopecia, myalgia, dyspepsia, insomnia, agitation, pallor, asterixis, weakness, tremor, hyporeflexia, drowsiness, hypothermia, increased urinary, frequency, skin hyperpigmentation, skin hypopigmentation, skin irritation, pruritus, xerosis, photosensitivity, vesicular rash. Tretinoin should not be used during pregnancy and breastfeeding. The safety and efficacy of topical tretinoin products have not been established in children and adolescents. Children should not take or come in contact with tretinoin. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Tretinoin-tretinoin-24012.

SPIRONOLACTONE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Before you start taking Spironolactone and each time you get a refill, review this section. This information does not replace discussing your medical condition or treatment with your healthcare provider. Spironolactone is FDA approved for the treatment of high blood pressure, heart failure, and conditions that have too much aldosterone in the body. Other uses, including treatment of hair loss, are considered off-label.

Side effects of Spironolactone may include hypersensitivity reactions (allergic reactions), hyperkalemia (elevated potassium levels in the blood) which can be severe and potentially fatal, gynecomastia (enlarged breast tissue in males), menstrual irregularities, breast pain or tenderness, erection difficulties, changes in voice pitch, deepening of the voice in females, hair growth or loss, skin rash or itching, fatigue, dizziness or lightheadedness, electrolyte imbalances including low sodium levels, nausea or vomiting, stomach pain, diarrhea or constipation, headaches, dehydration or thirst, confusion or mental changes, and muscle pain, spasms, or weakness.

Special Warnings and Precautions:

Comorbidities: Spironolactone should not be taken by patients with a history of hypotension, kidney disease or reduced kidney function, liver disease or reduced liver function, Addison's disease (chronic adrenal insufficiency), hyperkalemia or other conditions associated with hyperkalemia. Spironolactone carries a black box warning for being a tumorigen in chronic toxicity studies in rats. This means that in certain animal studies, spironolactone was associated with a potential risk of benign adrenal tumors (specifically adenomas). However, this risk has not been consistently observed in human studies, and the clinical significance of this finding in humans remains uncertain. It is not advised for spironolactone to be used in patients who have a history of (or at high risk for) breast cancer, ovarian cancer or other hormone sensitive cancer without discussing with their oncologist.

Pregnancy: Spironolactone is pregnancy category C, meaning it may cause harm to developing fetuses and should be avoided by women who are pregnant, planning pregnancy or breastfeeding.

Drug-interactions: Spironolactone can interact with several other drugs and substances, potentially affecting their effectiveness or causing adverse effects. Medications that should not be taken with spironolactone include:

  • Potassium-Sparing Diuretics: Concurrent use of other potassium-sparing diuretics (e.g., amiloride, triamterene) can lead to excessive potassium accumulation in the body, increasing the risk of hyperkalemia.
  • ACE Inhibitors and Angiotensin II Receptor Blockers (e.g. benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Zestril), irbesartan, valsartan, losartan and candesartan): Combining spironolactone with these medications, often used for heart failure or high blood pressure, can increase the risk of hyperkalemia.
  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): frequent NSAID use can contribute to kidney function changes and increased potassium levels.
  • Heparin and low molecular weight heparin: Concurrent use can lead to excessive potassium accumulation in the body, increasing the risk of hyperkalemia.
  • Trimethoprim: Concurrent use can lead to excessive potassium accumulation in the body, increasing the risk of hyperkalemia.
  • Lithium: Spironolactone can reduce the excretion of lithium, potentially leading to increased lithium levels and toxicity.
  • Digoxin: Spironolactone can affect digoxin levels in the blood, so close monitoring is needed when these drugs are used together.
  • CYP450 Inhibitors: Some drugs that inhibit the activity of liver enzymes, specifically CYP450 enzymes, can increase spironolactone levels in the blood, potentially leading to adverse effects.
  • Corticosteroids: Concurrent use of corticosteroids can enhance the risk of potassium imbalance and other electrolyte disturbances.
  • Warfarin: Spironolactone may alter the metabolism of warfarin, an anticoagulant, potentially affecting its blood-thinning effects.

Hyperkalemia: Potassium supplements and salt substitutes containing potassium should be avoided while on spironolactone, as this can increase the risk of hyperkalemia. Excess intake of foods that are known to have high potassium levels should be avoided (such as bananas, dried fruits, beans, lentils, potatoes, winter squash , spinach, broccoli, beet greens and avocados). Limiting or avoiding alcohol is also advised as it can enhance dizziness and the risk of dehydration and electrolyte imbalances. Hyperkalemia (high potassium levels in the blood) may present with symptoms of heart palpitations, shortness of breath, chest pain, nausea, or vomiting. Sudden or severe hyperkalemia is a life-threatening condition and requires acute medical care and you will need to seek urgent care at an emergency room or call 911 if any of the above symptoms arise. Regular monitoring, including blood tests to check kidney function and potassium levels, are not routinely required but may be necessary for some patients with risk factors for kidney dysfunction or electrolyte imbalances.

The above does not encompass all potential side effects, medication interactions or studies. Unreported or yet undiscovered side effects might exist. Please review the FDA prescribing information and the Prescriber’s Digital Reference (PDR) for a comprehensive overview of spironolactone:

When considering Spironolactone therapy, it’s essential to weigh the potential benefits against the potential risks.

Please refer to the drug’s Prescriber’s Digital Reference (PDR) for a comprehensive overview: https://www.pdr.net/drug-summary/Aldactone-spironolactone-978.2934. Always discuss any concerns, symptoms, or side effects with your healthcare provider. Lastly, every individual may respond differently to medications. It’s essential to stay informed and regularly consult with healthcare professionals to ensure the therapy remains suitable for you.

LATANOPROST SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Before you start taking Latanoprost and each time you get a refill, review this section. This information does not replace discussing your medical condition or treatment with your healthcare provider.

Latanoprost is an FDA approved medication that is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The use of Latanoprost as a hair loss treatment is considered off-label.

Special Warnings and Precautions:

Comorbidities: Latanoprost should be used with caution by patients with a history of eye inflammation (uveitis/iritis), macular edema or risk factors for macular edema, torn or missing lens, herpes infection of the eye, bacterial infection of the eye, or any other current eye condition. Do not use this medication if you have active intraocular inflammation. It is recommended that you get clearance from an ophthalmologist prior to starting use of Latanoprost if you have a history of eye conditions. Those with respiratory diseases such as asthma should also exercise caution as asthma exacerbation and respiratory tract infections have been reported with topical Latanoprost use.

Pregnancy: Latanoprost is pregnancy category C, indicating that its safety in pregnant women has not been fully established. It should be avoided by women who are pregnant, planning pregnancy, or breastfeeding unless deemed essential by a physician.

Potential for skin and eye pigment changes: When used as an eyedrop, Latanoprost has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as Latanoprost is administered. After discontinuation of Latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Beyond 5 years the effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

Most common side effects of Latanoprost when used as an eye drop:

  • Changes in iris color, which can be permanent.
  • Swelling or darkening of the skin of the eyelids.
  • Darkening of the skin around the eyes.
  • Eyelash changes, such as increased length, color, thickness, or number of lashes.
  • Redness, itching, or swelling of the eye.
  • Eye pain or stinging.
  • Blurred vision.
  • Sensitivity to light.
  • Foreign body sensation in the eyes.
  • Upper respiratory tract infections.
  • Dry eyes.
  • Irritation of the clear front surface of the eye.

The above does not encompass all potential side effects, medication interactions, or studies for Latanoprost. Because this medication has not been studied as a topical treatment for hair loss, the side effect profile for this indication is not known. Unreported or yet undiscovered side effects might exist. Please review the FDA prescribing information and the Prescriber’s Digital Reference (PDR) for a comprehensive overview of Latanoprost: https://labeling.pfizer.com/showlabeling.aspx?id=613

When considering Latanoprost therapy for hair loss, it’s essential to weigh the potential benefits against the potential risks. Always discuss any concerns, symptoms, or side effects with your healthcare provider. Lastly, every individual may respond differently to medications. It’s essential to stay informed and regularly consult with healthcare professionals to ensure the therapy remains suitable for you.

Please refer to the drug’s Prescriber’s Digital Reference (PDR) for a comprehensive overview of Latanoprost: https://www.pdr.net/drug-summary/?drugLabelId=Xelpros-latanoprost-24244.

TADALAFIL SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Before you start using Tadalafil and each time you get a refill, please review this section. There may be new information. You may also find it helpful to share this information with your partner. This information does not replace discussing your medical condition or treatment with your healthcare provider. You and your healthcare provider should talk about Tadalafil when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.


Tadalafil (Cialis®) is an FDA approved medication prescribed for the treatment of erectile dysfunction and symptoms of an enlarged prostate. While it is generally considered safe and effective, it's crucial to be informed about potential side effects that may occur during its usage.

Important Information About Tadalafil: Tadalafil can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Do not take Tadalafil if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

  • Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.
  • Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.


Tell all of your healthcare providers that you take Tadalafil. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Tadalafil.


After taking a single tablet, Tadalafil may remain in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications. 


Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.


Tadalafil is a prescription medicine taken by mouth for the treatment of erectile

dysfunction (ED) in men. ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. Tadalafil helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.


Some form of sexual stimulation is needed for an erection to happen with Tadalafil.


Tadalafil Does Not:

  • Cure ED.
  • Increase a man’s sexual desire.
  • Protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.
  • Serve as a male form of birth control.


Tadalafil is only for men over the age of 18 who have ED, including men with diabetes or who have undergone prostatectomy. Tadalafil is not for women or children. Tadalafil must be used only under a healthcare provider’s care.


Who Should Not Take Tadalafil: 

Do not take Tadalafil if you:

  • Take any medicines called “nitrates”.
  • Use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. 


Tadalafil is not right for everyone. Only your healthcare provider and you can decide if Tadalafil is right for you. Before taking Tadalafil, tell your healthcare provider about all your medical problems, including if you:

  • Are allergic to Tadalafil or any of its ingredients. 
  • Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take Tadalafil if your healthcare provider has told you not to have sexual activity because of your health problems.
  • Have low blood pressure or have high blood pressure that is not controlled.
  • Have had a stroke.
  • Have liver problems.
  • Have kidney problems or require dialysis.
  • Have retinitis pigmentosa, a rare genetic (runs in families) eye disease.
  • Have ever had severe vision loss, including a condition called NAION.
  • Have stomach ulcers.
  • Have a bleeding problem.
  • Have a deformed penis shape or Peyronie’s disease.
  • Have had an erection that lasted more than 4 hours.
  • Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia.


Effect of Other Medicines on Tadalafil: Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Tadalafil and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the following:

  • Medicines called nitrates.
  • Medicines called alpha blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) or Uroxatral® (alfuzosin HCl). Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If Tadalafil is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.
  • Other medicines to treat high blood pressure (hypertension)
  • Medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)
  • Ketoconazole (Nizoral®)
  • Itraconazole (Sporanox®)
  • Erythromycin
  • Other medicines or treatments for ED (e.g., Viagra®)


How to Take Tadalafil:

  • Take Tadalafil exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you. 
  • Some men can only take a low dose of Tadalafil or may have to take it less often, because of medical conditions or medicines they take.
  • Do not change your dose or the way you take Tadalafil without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to Tadalafil and your health condition.
  • Tadalafil may be taken with or without meals.
  • If you take too much Tadalafil, call your healthcare provider or emergency room right away.


There Are Two Ways to Take Tadalafil:

  • Tadalafil for use as needed: Do not take Tadalafil more than one time each day. Take one Tadalafil tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking Tadalafil and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take Tadalafil before sexual activity. Some form of sexual stimulation is needed for an erection to happen with Tadalafil. Your healthcare provider may change your dose of Tadalafil depending on how you respond to the medicine, and on your health condition.
  • Tadalafil for once daily use: Do not take Tadalafil more than one time each day. Take one Tadalafil tablet every day at about the same time of day. You may attempt sexual activity at any time between doses. If you miss a dose, you may take it when you remember but do not take more than one dose per day. Some form of sexual stimulation is needed for an erection to happen with Tadalafil. Your healthcare provider may change your dose of Tadalafil depending on how you respond to the medicine, and on your health condition.


What to Avoid While Taking Tadalafil:

  • Do not use other ED medicines or ED treatments (e.g., Viagra®) while taking Tadalafil 
  • Do not drink too much alcohol when taking Tadalafil (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.


Possible Side Effects of Tadalafil: The most common side effects with Tadalafil are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking Tadalafil. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.


Uncommon Side Effects of Tadalafil: An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections. Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including Tadalafil, reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including Tadalafil, and call a healthcare provider right away. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including Tadalafil. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking Tadalafil and contact a healthcare provider right away.


These are not all the possible side effects of Tadalafil. For more information, ask your healthcare provider or pharmacist.


How to Store Tadalafil: Store Tadalafil at room temperature between 59° and 86°F (15° and 30°C). Keep Tadalafil and all medicines out of the reach of children.


General Information About Tadalafil: Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use Tadalafil for a condition for which it was not prescribed. Do not give Tadalafil to other people, even if they have the same symptoms that you have. It may harm them.

Special Warnings and Precautions:

  • Cardiovascular Risk: Tadalafil can cause a temporary decrease in blood pressure, particularly when taken with other medications that lower blood pressure or with alcohol. Individuals with cardiovascular diseases or those at risk should use Tadalafil cautiously and consult their healthcare provider.
  • Interactions: Tadalafil may interact with certain medications, including nitrates, alpha-blockers, and drugs used to treat pulmonary hypertension. It is essential to inform your healthcare provider about all medications you are taking before starting Tadalafil.
  • Allergic Reactions: While rare, some individuals may experience allergic reactions to Tadalafil, characterized by rash, itching, swelling of the face, lips, or tongue, or difficulty breathing. Seek immediate medical attention if you experience any signs of an allergic reaction.

Tadalafil is generally well-tolerated and effective for the treatment of erectile dysfunction and other conditions. However, like any medication, it may cause side effects in some individuals. It is essential to be aware of these potential side effects and to consult with a healthcare provider if you have any concerns or experience adverse reactions while taking Tadalafil. Your healthcare provider can provide personalized advice and guidance based on your individual health status and medical history. 

The above does not encompass all potential side effects, medication interactions, or studies related to Tadalafil. Unreported or yet undiscovered side effects might exist. Please review the FDA prescribing information and the Prescriber’s Digital Reference (PDR) for a comprehensive overview of Tadalafil: