Important Safety Information — Compounded Minoxidil and Finasteride

What is this?

Compounded minoxidil and finasteride is a prescription topical formulation applied to the scalp. It contains minoxidil, a vasodilator, and finasteride, a 5-alpha reductase inhibitor.

Compounded minoxidil and finasteride is not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are dispensed.

This information does not include all possible risks, side effects, warnings, precautions, or interactions. Follow your prescription label, pharmacy instructions, and the instructions provided by your healthcare provider.

Who should not use compounded minoxidil and finasteride?

Do not use compounded minoxidil and finasteride if you are allergic to minoxidil, finasteride, or any ingredient in the formulation.

This medication is not suitable for use by women who are pregnant or may become pregnant. Finasteride may cause abnormalities of the external genitalia of a male fetus if exposure occurs during pregnancy.

Compounded minoxidil and finasteride is not suitable for children or pediatric use unless specifically prescribed by a qualified healthcare provider after appropriate evaluation.

Key warnings and precautions

Use only as directed. Apply this medication only to the scalp and only according to your prescription instructions. Do not apply extra medication or use it more often than directed.

Avoid damaged or irritated skin. Do not apply this medication to inflamed, infected, irritated, painful, sunburned, or damaged scalp unless specifically instructed by your healthcare provider. Damaged or irritated skin may increase absorption and the risk of systemic side effects.

Avoid contact with eyes and mucous membranes. Do not apply this medication to the eyes, mouth, broken skin, or other sensitive areas. If contact occurs, rinse the area with large amounts of cool water.

Wash hands after application. Wash your hands thoroughly after applying the medication unless your healthcare provider instructs otherwise.

Risk of transfer to others. Compounded minoxidil and finasteride may transfer to another person through direct contact with the application area, unwashed hands, pillowcases, hats, towels, or other items that contact the treated scalp.

Take precautions to prevent others from coming into contact with the medication, especially women who are pregnant or may become pregnant. Finasteride exposure during pregnancy may cause harm to a male fetus.

After applying this medication, wash your hands thoroughly. Allow the medication to dry before touching the treated area, going to bed, wearing hats or head coverings, or allowing another person to contact the application site.

If a woman who is pregnant or may become pregnant comes into contact with this medication, she should wash the exposed area with soap and water and contact a healthcare provider.

Risk of unwanted hair growth. Increased hair growth outside the intended application area, such as the face, beard, eyebrows, ears, or arms, has been reported with topical minoxidil and may occur from accidental transfer of the medication.

Possible systemic effects from topical minoxidil. Although topical minoxidil is applied to the scalp, systemic effects may occur, especially with excessive use, increased absorption, damaged skin, or sensitivity to the drug. Report chest pain, dizziness, fainting, rapid heartbeat, unexplained weight gain, swelling, or fluid retention to your healthcare provider.

Sexual side effects and mood changes. Finasteride has been associated with decreased libido, erectile dysfunction, ejaculation disorder, decreased ejaculate volume, testicular pain, and postmarketing reports of sexual dysfunction that continued after discontinuation. Depression, suicidal ideation, and suicidal behavior have also been reported.

Breast changes. Breast tenderness, breast enlargement, and male breast cancer have been reported with finasteride. Report breast lumps, pain, tenderness, enlargement, or nipple discharge to your healthcare provider.

PSA testing and prostate cancer screening. Finasteride can lower serum prostate-specific antigen, or PSA, levels. Tell your healthcare provider that you are using finasteride before PSA testing or prostate cancer screening. Any confirmed increase in PSA while using finasteride should be evaluated by a healthcare provider.

Liver impairment. Finasteride is metabolized extensively in the liver. Use caution and speak with your healthcare provider if you have liver function abnormalities.

Possible side effects

Possible side effects associated with topical minoxidil include scalp itching, dryness, scaling, flaking, local irritation, burning, and unwanted hair growth outside the application area. Systemic effects may include weight gain, swelling, rapid heartbeat, low blood pressure, dizziness, chest pain, or fluid retention.

Possible side effects associated with finasteride include decreased libido, erectile dysfunction, ejaculation disorder, decreased ejaculate volume, breast tenderness or enlargement, testicular pain, rash, itching, hives, and swelling of the lips, tongue, throat, or face. Postmarketing reports include sexual dysfunction that continued after discontinuation, orgasm disorders, male infertility or poor semen quality, hematospermia, depression, suicidal ideation and behavior, and male breast cancer.

Drug interactions

Tell your healthcare provider about all prescription medications, over-the-counter medications, topical products, supplements, and herbal products you use.

The safety and efficacy of combining topical minoxidil with other topical drugs on the scalp has not been established. Concomitant use with other topical drugs on the scalp is not recommended unless directed by your healthcare provider. Topical tretinoin may increase percutaneous absorption of minoxidil, and hypotensive agents such as guanethidine may increase the risk of orthostatic hypotension if systemic absorption of minoxidil occurs.

Pregnancy and exposure risk

Compounded minoxidil and finasteride should not be used by women who are pregnant or may become pregnant. Finasteride may cause harm to a male fetus. Exposure may occur if another person comes into contact with medication on the scalp, hands, pillowcases, hats, towels, or other contaminated items.

Prevent pregnant women and women who may become pregnant from touching the medication, the treated scalp before it has dried, or items that may have medication residue on them. If exposure occurs, wash the exposed area with soap and water and contact a healthcare provider.

Breastfeeding

Compounded minoxidil and finasteride is not intended for use while breastfeeding unless specifically directed by a healthcare provider. It is not known whether topical minoxidil is distributed into human milk, and finasteride is not indicated for use in women.

When to contact your healthcare provider

Contact your healthcare provider if you experience persistent scalp irritation, unwanted hair growth outside the application area, sexual side effects, testicular pain, mood changes, depression, breast tenderness, breast enlargement, breast lumps, nipple discharge, dizziness, swelling, unexplained weight gain, rapid heartbeat, or symptoms that concern you.

Seek emergency medical care

Seek emergency medical care if you experience chest pain, fainting, severe dizziness, shortness of breath, rapid heartbeat, severe allergic reaction, or swelling of the lips, tongue, throat, or face.

Missed dose

If you miss a dose, follow the instructions on your prescription label or contact your healthcare provider or pharmacy.

Do not apply extra medication to make up for a missed dose. Do not change your dosing schedule without medical direction.

Overdose or accidental exposure

In case of overdose or accidental exposure, seek medical attention immediately or contact Poison Control at 1-800-222-1222.

Storage

Follow the storage instructions provided by your pharmacy. Keep this medication out of reach of children and pets. Keep the container closed when not in use.

Do not use medication that appears contaminated, discolored, leaking, crystallized, damaged, or otherwise unusual.

Disposal

Do not flush unused medication down the toilet or pour it into a sink or drain unless specifically instructed. Follow local disposal guidance or ask your pharmacist how to dispose of unused medication.

Reporting side effects

Tell your healthcare provider if you experience side effects or symptoms that concern you. You may report suspected adverse reactions or product quality concerns to the FDA through MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.

Disclaimer

This information is not comprehensive and does not include all possible risks, side effects, interactions, warnings, or precautions associated with compounded minoxidil and finasteride. This page does not provide medical advice, diagnosis, or treatment.

Compounded minoxidil and finasteride is not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are dispensed.