Drug Safety Information

About your prescription

HAIRMDL® formulas are compounded topical medications: a licensed compounding pharmacy prepares your foam or solution to the prescription written by your physician. Compounded medications are made under state pharmacy law. They are not FDA-approved products, and the FDA has not reviewed them for safety, effectiveness, or quality. Several of the ingredients below are FDA-approved for other uses and are prescribed for hair loss “off-label,” which is a common and legal practice when a physician judges it appropriate.

This page summarizes the most important safety information for each ingredient your formula may contain. It is not a complete list of every possible side effect. Your physician considers your health history when prescribing; tell us about every medication, supplement, allergy, and medical condition, and about any change in your health while you are using the product.

For every HAIRMDL® formula

• For external use on the scalp only. Do not swallow. Keep away from the eyes, mouth, and broken or irritated skin. If the product gets in your eyes, rinse with cool water.
• Wash your hands after each application so the medication is not transferred to other parts of your body or to other people.
• Temporary shedding in the first 2 to 8 weeks is common and usually means the follicles are cycling into a new growth phase. Contact us if shedding is heavy or continues beyond 2 months.
• Scalp irritation (redness, dryness, flaking, itching, burning) is the most common side effect of topical hair-loss treatments. It is usually mild. If it is severe or does not settle, stop and contact us; your physician can adjust your formula.
• Do not use if you are pregnant, planning pregnancy, or breastfeeding unless your physician has specifically told you a particular formula is appropriate. See the dutasteride and tretinoin sections below.
• Keep out of reach of children and pets. Minoxidil in particular is toxic to pets if ingested or absorbed through the skin.
• Results vary. Most people who respond see less shedding within 2 to 3 months and visible regrowth within 4 to 6 months. Hair gained is maintained only while you keep using the treatment.

Minoxidil

A vasodilator FDA-approved as a topical treatment for hair loss. It prolongs the growth phase of the hair cycle and increases follicle size. HAIRMDL® uses a higher concentration than over-the-counter products, which your physician prescribes based on your intake.

Common side effects

• Scalp irritation, dryness, itching, or flaking.
• Temporary shedding in the first weeks.
• Unwanted hair growth on the forehead, temples, or face where the product spreads or is transferred by hands or pillows.

Less common but important

• Dizziness, light-headedness, rapid or irregular heartbeat, chest pain, swelling of the hands or feet, or sudden unexplained weight gain. These can indicate the medication is being absorbed into the bloodstream. Stop using the product and contact us; seek urgent care for chest pain or fainting.
• Headache.

Tell your physician before using if you

• Have heart disease, low blood pressure, or take blood-pressure medication.
• Have a scalp condition such as psoriasis, eczema, or sunburn.
• Are pregnant or breastfeeding.

Dutasteride

A 5-alpha-reductase inhibitor that lowers dihydrotestosterone (DHT), the hormone that shrinks follicles in pattern hair loss. It is FDA-approved as an oral medication for enlarged prostate; topical use for hair loss is off-label. Applying it to the scalp is intended to limit how much reaches the rest of the body, but some systemic absorption can occur.

Possible side effects

• Sexual side effects: decreased libido, erectile difficulty, or changes in ejaculation. These are uncommon with topical use and usually resolve after stopping, but a small number of people have reported symptoms that persisted.
• Breast tenderness or enlargement.
• Low mood or depressive symptoms.
• Dutasteride lowers PSA (prostate-specific antigen) readings. Tell any physician who orders a PSA test that you use it.
• Dutasteride stays in the body for months after the last dose. Do not donate blood while using it or for 6 months after stopping.

Tell your physician before using if you

• Have liver disease.
• Have a history of depression or sexual dysfunction.
• Take other 5-alpha-reductase inhibitors (finasteride, oral dutasteride) or are being evaluated for prostate conditions.

Latanoprost

A prostaglandin analog FDA-approved as an eye drop for glaucoma; its effect on eyelash growth led to off-label use for scalp hair at low concentrations.

Possible side effects

• Scalp redness or itching.
• Darkening of the skin where it is applied, and darkening or thickening of nearby hair.
• If the product contacts the eyes: eye irritation, eyelash growth, darkening of the eyelid skin, and, with repeated exposure, a permanent increase in brown pigment in the iris. Keep it well away from the eyes.

Tell your physician before using if you

• Have any eye condition, use eye drops, or have had eye surgery or inflammation.
• Are pregnant or breastfeeding.

Tretinoin (retinoic acid)

A vitamin A derivative FDA-approved for acne and photo-aging. In hair formulas it is included at a low concentration to increase absorption of minoxidil.

Possible side effects

• Redness, peeling, dryness, stinging, or itching, especially in the first weeks.
• Increased sensitivity to sunlight. Protect your scalp with a hat or sunscreen and avoid tanning beds.

Tell your physician before using if you

• Have eczema, rosacea, or very sensitive skin.
• Use other retinoid products, benzoyl peroxide, or exfoliating acids on your scalp.

Triamcinolone

A mid-potency corticosteroid included at a low concentration to reduce the scalp irritation that other ingredients can cause.

Possible side effects

• Mild burning or itching when first applied.
• With prolonged daily use: thinning of the skin, visible small blood vessels, lightening of skin color, acne-like bumps, or folliculitis at the application site.
• Rarely, with large areas or long-term use, enough can be absorbed to affect the body’s own cortisol. Use only as directed.

Tell your physician before using if you

• Have a scalp infection (bacterial, fungal, or viral).
• Have diabetes, glaucoma, or cataracts.
• Use other steroid creams, inhalers, or tablets.

Caffeine

Included for its effect on follicle energy metabolism and to help counter DHT at the follicle. Topical caffeine is generally well tolerated.

• Possible mild scalp irritation.
• Absorption is low, but if you are very sensitive to caffeine and notice jitteriness or trouble sleeping after applying the product, tell us.

Exosomes (Exosome product line only)

Exosomes are tiny vesicles derived from cells that carry growth factors and signaling molecules. The HAIRMDL® Exosome line adds a topical exosome ingredient intended to support the follicle environment. Exosome products are not FDA-approved for any use, and the evidence for hair growth comes from small studies; benefits are not established the way they are for minoxidil or dutasteride.

• Possible mild redness or irritation at the application site.
• Rarely, allergic reaction. Stop and contact us if you develop hives or swelling.
• Tell your physician if you have an autoimmune condition, a history of skin cancer on the scalp, or a compromised immune system.

Interactions and combinations

• Do not combine your HAIRMDL® formula with other minoxidil products, other topical retinoids, or other 5-alpha-reductase inhibitors unless your physician has approved it.
• Tell us about blood-pressure medication, blood thinners, oral steroids, hormone therapy, and any medication for prostate conditions.
• Wait until the product has dried before applying styling products, and apply it to a clean, dry scalp. Do not use a hair dryer on the treated area immediately after application.

Reporting side effects

If you experience a side effect, stop using the product and contact us at support@hairmdl.com or (877) 424-7635. Our clinical team will review it with your physician, who may adjust or stop your treatment. You can also report side effects of any medication to the FDA MedWatch program at fda.gov/safety/medwatch or 1-800-FDA-1088.

How we deliver care, and your rights as a telehealth patient, are described in our Telehealth Informed Consent.