Minoxidil + Finasteride + Vitamin D

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Safety information

This treatment combines two prescription medications in one tablet, so both sets of information below apply to you. Please read both before you start, and keep them for each refill.

Oral minoxidil, including the Vitamin D combination

Before using minoxidil and each time you get a refill please review the following important safety details. This information may be updated. It does not replace discussing your health conditions or treatment plan with your medical provider.

FDA-Approved Uses of Minoxidil

Topical Minoxidil

• 2% and 5% topical minoxidil solutions/foams are FDA-approved for treating hair loss in men and women.
• All compounded topical strengths (7%, 10%, etc.) are considered off-label.

Oral Minoxidil

• Oral minoxidil is FDA-approved for treating symptomatic high blood pressure , not hair loss.
• Oral minoxidil may be prescribed off-label for hair loss when medically appropriate.
• Oral minoxidil combined with other ingredients (e.g., Vitamin D) is a compounded, off-label product and is not FDA-approved for treating hair loss.

What Should I Tell My Healthcare Provider Before Taking Minoxidil?

Please inform your clinician if any of the following apply:

Heart or Cardiovascular History

• High or low blood pressure
• Heart failure
• Previous heart attack
• Pericarditis
• Chest pain or angina
• Irregular heart rhythm
• History of stroke
• Severe swelling in the lower legs
• Pulmonary hypertension

Kidney or Liver Conditions

• Any history of kidney disease or reduced kidney function
• Any history of liver disease or dysfunction

Other Health Considerations

• History of serious mental health conditions
• Pregnancy, trying to become pregnant, or breastfeeding
• Current Vitamin D supplementation*
• High blood calcium levels* *Applies to compounded oral minoxidil with Vitamin D

Pets

Minoxidil can be toxic to some animals. Do not allow pets to lick your hands or any treated areas.

Who Should Not Use Minoxidil?

You should not use minoxidil if you:

• Have ever had an allergic reaction to minoxidil
• Have significant liver disease or dysfunction
• Have high blood calcium levels*
• Are pregnant, may be pregnant, or are breastfeeding
• Are an infant or child

*For compounded formulas containing Vitamin D

Black Box Warning: Serious Cardiac Effects (Oral Minoxidil)

Oral minoxidil carries an FDA black box warning because it is a strong antihypertensive medication.

When used at low doses for hair loss:

• Doses are typically under 5 mg to help reduce cardiovascular risks.
• Even at low doses, serious side effects are still possible and require caution.

Serious Cardiac Risks Include:

• Pericardial effusion (fluid around the heart), which can progress to cardiac tamponade , a life-threatening emergency.
• Severe chest pain
• Shortness of breath
• Fast or irregular heartbeat
• Worsening of existing heart issues, including heart failure

Seek emergency care immediately if you develop severe chest pain, difficulty breathing, or fainting.

Chest Pain Warning

Minoxidil may increase heart rate or cause/worsen chest discomfort. If you develop new or worsening chest pain, contact a clinician or go to the emergency room.

Possible Side Effects of Minoxidil

Common or Mild Side Effects

• Temporary increase in hair shedding (first few weeks)
• Scalp itch or rash
• Flakiness, dryness, or irritation
• Redness at the application site
• Unwanted facial or body hair
• Dizziness or lightheadedness

More Serious or Concerning Side Effects

• Rapid or irregular heartbeat
• Chest pain or palpitations
• Swelling of hands, feet, or face
• Fainting or severe dizziness

This list does not include all potential side effects, medication interactions, or clinical data. Always notify your clinician and/or pharmacist of any side effects you experience.

Learn More About Minoxidil

A detailed scientific review of minoxidil can be found here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691938/

Additional prescriber information (oral minoxidil): https://www.pdr.net/drug-summary/?drugLabelId=774

Emergency Situations

If you experience symptoms of an allergic reaction, chest pain, severe dizziness, fainting, or difficulty breathing, call 911 or seek immediate emergency medical care.

You can report negative side effects to the FDA at: www.fda.gov/medwatch or 1-800-FDA-1088

Additional safety information

* Oral minoxidil is not FDA-approved for treating hair loss. It must be prescribed based on an online medical evaluation, and individual responses vary.

Finasteride

Before using finasteride and each time you get a refill, please review the following important safety details. This information may be updated. It does not replace discussing your health conditions or treatment plan with your medical provider.

FDA-Approved Uses of Finasteride

Oral Finasteride

Finasteride 1 mg is FDA-approved for the treatment of male pattern hair loss. Finasteride 5 mg is FDA-approved for the treatment of benign prostatic hyperplasia (BPH).

Topical and compounded forms of finasteride are considered off-label.

What Should I Tell My Healthcare Provider Before Taking Finasteride?

Please inform your clinician if any of the following apply:

Hormonal or Reproductive History

• History of infertility
• Actively trying to conceive
• History of hormone-related conditions

Mental Health History

• History of depression
• History of anxiety disorders
• Prior mood-related side effects from medications

Liver Conditions

• Any history of liver disease
• Any abnormal liver function tests

Other Health Considerations

• Allergy or sensitivity to finasteride
• Use of other hormone-modifying medications

Who Should Not Use Finasteride?

You should not use finasteride if you:

• Have ever had an allergic reaction to finasteride
• Are pregnant, may become pregnant, or are breastfeeding
• Are a child
• Have known hypersensitivity to 5-alpha reductase inhibitors

Pregnancy Warning

Finasteride can cause abnormalities in a male fetus. Pregnant individuals should not handle crushed or broken finasteride tablets.

Possible Side Effects of Finasteride

Common or Mild Side Effects

• Reduced libido
• Changes in ejaculation
• Erectile difficulty
• Mild fatigue

Less Common but More Serious Side Effects

• Breast tenderness or enlargement
• Testicular discomfort
• Mood changes, including depression
• Allergic reactions (rash, swelling, itching)

This list does not include all potential side effects, medication interactions, or clinical data. Always notify your clinician and or pharmacist of any side effects you experience.

Mental Health Advisory

Some patients report mood-related side effects while using finasteride. If you experience new or worsening depression, anxiety, or mood changes, contact your clinician immediately.

Fertility Considerations

Finasteride may affect semen parameters in a small percentage of patients. These effects are typically reversible after discontinuation. If you have concerns regarding fertility, discuss them with your clinician before starting treatment.

Learn More About Finasteride

A detailed scientific review of finasteride can be found here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3481923/

Additional prescriber information: https://www.pdr.net/drug-summary/Propecia-finasteride-1678

Emergency Situations

If you experience symptoms of a severe allergic reaction, fainting, swelling of the face or throat, or severe mood changes, call 911 or seek immediate emergency medical care.

You can report negative side effects to the FDA at: www.fda.gov/medwatch or 1-800-FDA-1088

Additional safety information

* Finasteride is FDA-approved for the treatment of male pattern hair loss. It must be prescribed following an online medical evaluation, and individual results may vary.