Minoxidil Tablets

Safety Information

Before you start using minoxidil and each time you get a refill, please review this important safety information. This information may be updated. It does not replace discussing your medical condition or treatment with your doctor or healthcare provider.

What is the FDA-approved use of minoxidil?

• Topical minoxidil is FDA approved at concentrations of 2% and 5% as topical formulations to treat hair loss in women and men (Rogaine®). All other topical compounded strengths of minoxidil are considered off-label uses.
• Oral minoxidil is FDA-approved for the treatment of symptomatic high blood pressure.
• Oral minoxidil is not FDA-approved to treat hair loss, but may be prescribed off-label for this condition.
• Oral minoxidil compounded with Vitamin D is not FDA-approved to treat hair loss.

What should I tell my healthcare provider before taking minoxidil?

Please inform your doctor or healthcare provider if any of the following apply:

• You have a history of heart conditions (e.g., high blood pressure, heart failure, previous heart attack, pericarditis, abnormal heart rhythm, chest pain/angina)
• You have a history of vascular conditions (e.g., stroke, severe lower leg swelling, pulmonary hypertension)
• You have a history of liver or kidney disease or dysfunction
• You have a history of any serious mental health conditions
• You are pregnant, trying to get pregnant, or are breastfeeding
• You are currently taking a Vitamin D supplement*
• You have high blood levels of calcium*

*applies to compounded oral minoxidil with Vitamin D

You should be aware that minoxidil has the potential to be toxic to some animals. Please ensure that pets do not come into contact with minoxidil or lick your hands after application.

It is rare for Vitamin D to cause side effects at the prescribed doses. If you are taking a Vitamin D supplement, consult your doctor before taking compounded oral minoxidil with Vitamin D.

Who should not take minoxidil?

You should not take minoxidil if you:

• Have ever had an allergic reaction to minoxidil
• Have a history of liver disease or dysfunction
• Have high blood levels of calcium*
• Minoxidil should not be used by women who are pregnant, may be pregnant or are breastfeeding
• Minoxidil should not be used by infants or children

Black box warning: Serious cardiac effects associated with oral minoxidil

• Oral minoxidil has a black box warning because the medication is a powerful antihypertensive agent. Serious cardiovascular side effects have been observed in clinical trials where the drug has been used to treat symptomatic high blood pressure. When used off-label for hair loss, oral minoxidil is typically dosed at less than 5mg to help reduce the likelihood of experiencing an adverse cardiovascular event.
• Oral minoxidil can cause pericardial effusion, which can progress to a condition called tamponade which increases pressure on the heart and keeps it from beating properly. This can result in sharp chest pain and difficulty breathing. Seek emergency treatment if this occurs.
• Chest pain warning: Minoxidil can increase your heart rate and cause or worsen chest pain. If you have new or worsening pain in the chest, arm, or shoulders, tell your doctor right away or go to the nearest emergency department.
• Heart function warning: Minoxidil can cause poor heart function or worsen existing heart problems like heart failure. When tested on animals, minoxidil caused several kinds of lesions of the heart muscle as well as other adverse heart effects. Patients with malignant hypertension and those already receiving guanethidine should be hospitalized when minoxidil is first administered so that they can be monitored to avoid too rapid or large decreases in blood pressure.
  
  

What are the possible side effects of minoxidil?

The following side effects have been reported with oral and topical minoxidil use:

• A temporary increase in shedding/hair loss in the first weeks of use
• Itchy scalp or skin rash
• Dryness, scaling, or flakiness of the scalp
• Redness or irritation at the application site
• Unwanted facial or body hair growth (especially in women)
• Dizziness or light-headedness
• Rapid or irregular heartbeat
• Chest pain or palpitations
• Swelling of hands, feet, or face

The above list does not represent all potential side effects, medication interactions or study data relating to the safety of minoxidil. It is important to talk to your doctor, healthcare provider and/or pharmacist if you are experiencing any side effects.

A comprehensive review of minoxidil, its clinical applications and safety can be found at this link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6691938/.

If you are experiencing a medical emergency or allergic reaction, call 911 or seek immediate medical attention.

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional safety information can be found here, in the Digital Prescriber’s Reference for oral minoxidil: https://www.pdr.net/drug-summary/?drugLabelId=774.