Please read below to familiarize yourself with the potential risks of the ingredients contained in your hair loss treatment. Side effects may be less common and less severe when these ingredients are used topically because the medication is focused at the hair follicles instead of being distributed systemically. If you experience side effects, please report them immediately to your doctor and stop taking the medication until advise further. If you ever develop any serious side effects, please stop these medications and go to the nearest emergency room or call 911 immediately.
All the information provided is not all inclusive, further references are provided for your review, please make sure to read and understand them. By accessing this Drug Safety & Information page, you acknowledge that you have accurately reported your medical history and properly communicated any prior or existing medical conditions to your prescribing physician and understands and agrees that you have been fully informed about the side effects.
-PROGESTERONE: is a naturally occurring hormone in both men and women which plays a pivotal role in various body functions. Progesterone can beneficially impact hair growth by counteracting Dihydrotestosterone’s (DHT) impact on the hair follicle (a major contributor to androgenetic alopecia), it can extend the growth phase of the hair cycle and enhance blood circulation to the scalp. Your topical formulation includes micronized progesterone which is a bioidentical hormone that is similar to the progesterone that your body makes naturally. Micronized progesterone is FDA approved as an oral therapy for endometrial hyperplasia and secondary amenorrhea in women. Topical progesterone is an off-label treatment for hair loss. Progesterone has not been studied as a topical treatment for hair loss so the specific side effect profile of topical progesterone is not known. When used orally the most frequent side effects of oral progestins include headache, breast tenderness, dizziness, abdominal pain, depression, viral diseases, or blurred vision/double vision/visual disturbance.
*YOU SHOULD NOT USE PROGESTERONE THERAPY IF YOU ARE:
-Currently pregnant/breastfeeding or planning pregnancy
-Have a history of any of the following:
-Allergy/hypersensitivity to progesterone products
-Blood clots, acute thrombophlebitis or thromboembolic or other clotting disorders
-Breast/Ovarian/Cervical/Endometrial cancer
-Liver disease
-Missed abortion or ectopic pregnancy
-Abnormal vaginal bleeding outside of your normal menses which has not been evaluated/treated
-History of a stroke or reduce blood flow to the brain (cerebral apoplexy)
-History of heart attack or active coronary artery disease with chest pain/angina
-Uncontrolled major depression or other psychological disorder
-Dementia or other neurological disorder
Please let your provider know if you are at high risk for any of the above conditions or have any of the following risk factors:
Family history of breast/genital cancer, family history of blot clots or clotting disorder, depression that is not treated/stable, endometriosis, diabetes, hypertension, smoker, have bone mineral density changes or other bone disease, kidney disease or reduced kidney function, systemic lupus erythematosus (SLE), migraines, asthma or epilepsy.
If you take warfarin or other oral anticoagulants your dosage may need to be adjusted while using progesterone.
Discontinue if any of the following develop: yellowing of the skin, visual problems (may cause contact lens intolerance), any signs/symptoms of a blood clot, migraine with unusual severity, significant blood pressure increase, or severe depression. You should discontinue use 4 weeks before major surgery or during any period of prolonged immobilization. Make sure to read the links provided to understand and familiarized yourself with all potential side effects.
-FINASTERIDE: is FDA approved as an oral medication to treat androgenetic alopecia (Propecia) in men. It functions to block the conversion of Testosterone to Dihydrotestosterone (DHT) at the hair follicle, which is thought to be the major contributor to androgenetic alopecia. Finasteride has not been FDA approved for topical use or for use in women, but is commonly used off-label in topical preparations for hair loss.
-DUTASTERIDE: Dutasteride has the same mechanism as Finasteride, but has a stronger ability to block DHT conversion and has a longer half life (stays in your body longer). Dutasteride is FDA approved as an oral medication for the treatment of benign prostatic hyperplasia in men and is commonly used off-label in oral and topical forms to treat androgenetic alopecia.
-FINASTERIDE/DUTASTERIDE side effects may include sexual side effects (such as decreased libido, erectile dysfunction, reduced sperm quality and gynecomastia) and psychological side effects such as depression, anxiety, or brain fog. These side effects have been demonstrated to resolve when the medication is discontinued, but in very rare cases, may be long lasting. If you have a history of severe or untreated depression or another mental health condition, we advise consulting with a mental health professional prior to starting therapy. There have been rare reports of breast cancer in patients taking finasteride/dutasteride so it is not advised to take this medication if you have a prior history of or are at high risk for breast cancer or other hormone sensitive cancers. *Prostate/PSA: It is critical that you inform all your healthcare providers that you are taking Finasteride/Dutasteride because it can lower your PSA results. Your provider will need to adjust their interpretation of your results and may want to check your PSA more frequently (for patients over 40). If you have a history of prostate cancer or are at high risk, you will need to discuss Finasteride/Dutasteride with your urologist/oncologist before starting treatment because there is some evidence that these medications may increase the risk for developing a high-grade prostate cancer. Please inform your provider if you have any history of urological problems, BPH or current symptoms of reduced urine flow because it is advised that you have your prostate evaluated prior to starting Finasteride/Dutasteride.
*PREGNANCY: Finasteride/Dutasteride are Category X teratogenic medications that can cause birth defects in male fetuses. Women who are actively planning to get pregnant, are pregnant or breastfeeding should avoid contact with Finasteride/Dutasteride. For males, if you are planning pregnancy, there is some evidence that these medications may 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/Dutasteride during conception or while a partner is pregnant. You must not donate blood while on Finasteride and for 6 months after stopping Dutasteride to prevent female recipients from being exposed.
The above is not a complete list of all side effects, for further information please follow the link provided below.
-MINOXIDIL: side effects may include irritation, redness, low blood pressure, headaches, chest pain and shortness of breath, rapid irregular heartbeat/palpitations, swelling of hands/feet, fluid retention/weight gain, faintness, dizziness or flushing, some initial shedding of hair during first 1-3 months and hair growth on other parts of the body. Please let your provider know if you have any history of cardiac or vascular disease (particularly any active chest pain/angina), as this medication may not be safe for you. Minoxidil is classified as pregnancy risk category C and should not be administered to a nursing mother. It is important to keep Minoxidil out of reach of children and avoid exposing it to pets, as it may be harmful to them. Please review the link provided below for complete medication information.
-LATANOPROST: (sold under the brand name Xalatan) is a medication that is FDA approved to treat increased pressure inside the eye, including ocular hypertension and glaucoma. While Latanoprost is not FDA approved to treat hair loss, it is commonly used off label for hair loss because it mimics naturally derived prostaglandins which can stimulate hair follicle activity and may increase hair density. Latanoprost side effects may include itching, irritation and skin hyperpigmentation when used topically. When Latanoprost applied, increase in brown pigmentation of the iris, blurred vision, burning and stinging, itching, lid edema, chest pain/angina pectoris, rash/allergic skin reactions, dizziness, headache, muscle/joint/back pain have been occurred. Please inform your provider if you have a history of closed angle, inflammatory or neovascular glaucoma, any other active intraocular inflammatory disorders (uveitis, iritis) or a history of a torn lens or no lens in the eye (aphakia), as Latanoprost would not be safe for you to use without consulting with your ophthalmologist prior to starting therapy. Make sure to read the links provided to understand and familiarized yourself with all potential side effects.
-TRETINOIN (Retinoic Acid): may cause mild redness, irritation and peeling/flaking of the skin. This typically improves over time as your skin gets used to the medication. Tretinoin should not be used during pregnancy and breastfeeding. Children should not take or come in contact with Retinoic acid. Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted. Keep out of reach of children. Keep bottle tightly closed. Do not expose to heat or store at temperatures above 120°F (49°C). If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of tretinoin, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Tretinoin preparations for topical treatment should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, should use the medication less frequently, discontinue use temporarily, or discontinue use altogether. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition. For full disclosures please read following links and other links provided. https://www.pdr.net/drug-information/?druglabelid=1786
-NIACINAMIDE: is very well tolerated on the skin but rare side effects can include redness, itching, mild burning or allergic reactions. Tell your provider or get medical help right away if have Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of high blood sugar like confusion, feeling sleepy, more thirst, passing urine more often, flushing, fast breathing, or breath that smells like fruit. Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Muscle pain or weakness. Chest pain or pressure. Dizziness or passing out. Shortness of breath. Sweating a lot. High doses of niacin can cause rapid heartbeat, gout, liver damage, diabetes, abdominal pain, nausea and vomiting, Itching, severe skin flushing combined with dizziness. Some possible interactions include alcohol, Allopurinol, anticoagulant and anti-platelet drugs, herbs and supplements, blood pressure drugs, chromium, diabetes drugs, hepatotoxic drugs, statins, and zinc. Make sure to read the links provided to understand and familiarized yourself with all potential side effects.
-MELATONIN: when taken orally, may cause somnolence, headache, stomach ache, dizziness, restlessness, itching, dry mouth. Topical side effects are expected to be minimal. Melatonin is generally safe for short-term use. Unlike with many oral medications, with melatonin you are unlikely to become dependent on it, have less response to it after repeated use. The most common melatonin side effects include, headache, dizziness, nausea, daytime drowsiness, other, less common melatonin side effects might include, vivid dreams or nightmares, short-term feelings of depression, irritability, stomach cramps, diarrhea, constipation, decreased appetite, urinary incontinence at night, increased risk of falls, increased risk of seizures, confusion or disorientation, mood swings, reduced alertness. Make sure to read the links provided to understand and familiarized yourself with all potential side effects.
-HYDROCORTISONE: long-term use of a topical steroid may be associated with localized skin lightening (higher risk in darker skin types), skin thinning, more visible blood vessels, and acne. However, the scalp is one of the thickest areas of skin on the body, so use of this 1% preparation has a lower risk of causing thinning. You should never use this medication on your face or other areas of your body. Please reach out if you have concerns about the use of topical steroid at any time and it can be removed from your formulation. Your scalp should get used to your formulation after 3-4 months of therapy and at this time we suggest that you reach out to adjust your formulation to remove the hydrocortisone. Hydrocortisone should not be used during pregnancy and breastfeeding. Children should not take or come in contact with Hydrocortisone. Hydrocortisone is for the temporary relief associated with minor skin irritations, inflammation and rashes, it’s for external use only, should avoid contact with the eyes. Make sure to read the links provided to understand and familiarized yourself with all potential side effects.
-SPIRONOLACTONE: side effects may include lowered blood pressure, dizziness, lightheadedness/fainting, increased urination, increase in potassium levels in the blood, headaches, irregular periods or lack of menstrual periods, breast enlargement, breast tenderness and some may experience changes in hair texture/color. Topical preparations may have a distinct smell. Please let us know if you have a history of kidney disease/dysfunction, electrolyte imbalances, adrenal gland disorder or heart disease because this medication may not be safe for you. If you have a history of breast cancer or other hormone sensitive cancer, it is advised that you discuss with your oncologist before starting spironolactone. Treating hair loss with Spironolactone is off-label use. The FDA has approved Spironolactone for managing high blood pressure, heart failure, and conditions characterized by excessive aldosterone levels in the body. Spironolactone has the potential to interact with various other medications and substances, which may influence their efficacy or lead to unwanted side effects. Women who are pregnant, planning to become pregnant, or breastfeeding should avoid taking Spironolactone.
Make sure to let your provider know what other medications you are taking. Make sure to read the links provided to understand and familiarized yourself with all potential side effects.
Additional side effects of medications are possible as well, you may also view the complete medication information for all ingredients below:
https://www.pdr.net/drug-summary/Minoxidil-minoxidil-774
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019781s013lbl.pdf
https://reference.medscape.com/drug/prometrium-progesterone-micronized-342792#4
https://www.pdr.net/drug-information/?druglabelid=733
https://www.pdr.net/drug-summary/Xalatan-latanoprost-2298
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020597s044lbl.pdf
https://reference.medscape.com/drug/xalatan-latanoprost-343606#4
https://www.pdr.net/drug-summary/Propecia-finasteride-378.609
https://www.pdr.net/drug-summary/Avodart-dutasteride-176
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf
https://www.pfsfoundation.org/about-pfs-post-finasteride-syndrome/
https://www.pdr.net/drug-information/?druglabelid=1786
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4889c7f8-37d0-4f1a-9829-bca107806586
https://www.pdr.net/drug-information/?druglabelid=978
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb66327e-8261-46ae-b39a-4fa79d520844
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012151s075lbl.pdf
https://www.pdr.net/drug-information/?druglabelid=3417
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f351b04-8f6d-4353-9100-13a8a80d656a
https://www.drugs.com/sfx/niacinamide-side-effects.html
https://www.mayoclinic.org/drugs-supplements-niacin/art-20364984
https://reference.medscape.com/drug/vitamin-b3-niacor-niacin-344422
https://www.webmd.com/vitamins/ai/ingredientmono-940/melatonin
https://www.mayoclinic.org/drugs-supplements-melatonin/art-20363071
You can find additional information about hair loss and androgenetic alopecia in Men here:
https://dermnetnz.org/topics/hair-loss
https://dermnetnz.org/topics/male-pattern-hair-loss
You can find additional information about hair loss and androgenetic alopecia in women here:
https://dermnetnz.org/topics/hair-loss
https://dermnetnz.org/topics/female-pattern-hair-loss