DRUG SAFETY & 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 CLUB VIEW CAPITAL DBA HAPPY HEAD, 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, 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

By viewing this Drug Safety & Information page, you confirm that you have provided accurate medical history and correctly informed your prescribing physician of any cardiac, vascular, liver or kidney disease and have been examined by a physician to confirm your health prior your telemedicine visit. Systemic Minoxidil is a potent vasodilator with potential to produce hypotension and reflex tachycardia; serious complications may occur. Minoxidil is relatively contraindicated in patients with cardiac disease (including angina, coronary artery disease, recent or acute myocardial infarction), or cerebrovascular disease because a reflex increase in heart rate and decrease in blood pressure can exacerbate these conditions. Side effects may include pericardial effusion, heart failure, cardiac tamponade, pericarditis, Stevens-Johnson syndrome, allergic reaction, swelling of extremities, edema, peripheral edema , sodium retention, hypotension, angina, sinus tachycardia, leukopenia, thrombocytopenia, bullous rash, contact dermatitis, erythema, mastalgia, headache, hypertrichosis, pruritus, xerosis, vomiting, nausea, irritation, flakiness, itch, tingling and burning. This medication may burn the skin, temporarily or permanently and may cause permanent scarring alopecia.

If applied with fingertips, wash hands thoroughly after applying. If the metered-spray applicator is used, avoid inhalation of the mist. Minoxidil is classified as pregnancy risk category C. Although no adequate human studies have examined the effects of this drug on the fetus, animal reproduction studies have shown adverse effects, including reduced ability to conceive and a reduced survival of offspring. Dysmorphic facial features and hypertrichosis were observed in an infant whose mother took oral Minoxidil during pregnancy. According to the manufacturer, Minoxidil should not be administered to a nursing mother. Skin abrasion or irritations, such as excoriations, psoriasis, or sunburn, can increase the systemic absorption of topically administered Minoxidil. 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. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Minoxidil-minoxidil-774.

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.

HYDROCORTISONE SIDE EFFECTS: FULL DISCLOSURE AND NOTICE TO USERS

Side effects may include: exfoliative dermatitis, increased intracranial pressure, papilledema, tendon rupture, bone, fractures, avascular necrosis, esophageal ulceration, GI perforation, pancreatitis, GI bleeding, peptic ulcer, skin atrophy, anaphylactoid reactions, lupus-like symptoms, angioedema, heart, failure, seizures, optic neuritis, retinopathy, visual impairment, ocular hypertension, cardiac, arrest, thrombosis, pulmonary edema, stroke, bradycardia, vasculitis, cardiomyopathy, rosacea, peri-oral dermatitis, myocardial infarction, arrhythmia exacerbation, thromboembolism, erythema, hypothalamic-pituitary-adrenal (HPA) suppression, hypotension, physiological dependence, pseudotumor cerebri, withdrawal, adrenocortical insufficiency, hypothyroidism, Cushing’s, syndrome, hyperthyroidism, postmenopausal bleeding, osteopenia, myopathy, osteoporosis, constipation, gastritis, impaired wound healing, skin ulcer, candidiasis, neutropenia, immunosuppression, hypertension, hypokalemia, hypernatremia, hypocalcemia, metabolic, alkalosis, edema, fluid retention, sodium retention, neuritis, psychosis, memory impairment, peripheral neuropathy, euphoria, mania, delirium, hallucinations, EEG changes, amnesia, depression, impaired cognition, exophthalmos, blurred vision, ocular infection, cataracts, glycosuria, hyperglycemia, diabetes mellitus, phlebitis, hypercholesterolemia, sinus tachycardia, palpitations, angina, tolerance, growth inhibition, hepatomegaly, elevated hepatic enzymes, contact dermatitis, anemia, glossitis, pruritus, maculopapular rash, xerosis, skin irritation, lethargy, fever, dysmenorrhea, amenorrhea, menstrual irregularity, arthralgia, myalgia, arthropathy, weakness, abdominal pain, appetite stimulation, nausea, weight gain, vomiting, hiccups, anorexia, weight loss, diarrhea, petechiae, urticaria, acne vulgaris, telangiectasia, folliculitis, alopecia, skin hyperpigmentation, acneiform rash, hypertrichosis, rash, miliaria, perineal pain, diaphoresis, striae, purpura, ecchymosis, hirsutism, injection site reaction, skin, hypopigmentation, leukocytosis, infection, vertigo, restlessness, malaise, irritability, anxiety, headache, emotional lability, paresthesias, insomnia, syncope, dizziness. Hydrocortisone should not be used during pregnancy and breastfeeding. The safety and efficacy of topical Hydrocortisone products have not been established in children and adolescents. Children should not take or come in contact with Hydrocortisone. The side effects of long-term use of Hydrocortisone have not been established in clinical studies. Happy Head formula does contain Hydrocortisone 1% and you are placed on notice regarding the long-term side effects, which include, but are not limited to, the side effects listed above. If you do not want the Hydrocortisone included in the Happy Head product, please notify us and your formula will be customized to remove the Hydrocortisone. You are giving consent allowing us to use Hydrocortisone in your product, and understand and agree to the side effects. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Hydrocortisone-Lotion-2-5–hydrocortisone-3417.4123.

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. 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: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf
https://www.pdr.net/drug-summary/Aldactone-spironolactone-978.2934
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.