Important safety information

ORAL MINOXIDIL MAY CAUSE SERIOUS SIDE EFFECTS THAT IMPACT THE HEART, INCLUDING PERICARDIAL EFFUSION AND TAMPONADE. WHEN TESTED ON ANIMALS, MINOXIDIL CAUSED LESIONS OF THE HEART AS WELL AS OTHER ADVERSE HEART EFFECTS

Side Effects & Risks:

Oral minoxidil has a black boxed warning for serious cardiac events.

• Minoxidil may cause pericardial effusion, the accumulation of fluid in the sac that surrounds the heart (pericardium). This may progress to tamponade and angina pectoris
• When tested on animals, minoxidil caused lesions of the heart as well as other adverse heart effects.

Oral minoxidil may also contribute the following:

• Pleural effusion, the accumulation of fluid between the layers of tissue that line the lungs and chest cavity
• Hypotension or blood pressure that is lower than normal. This may also result in lightheadedness
• Hypertrichosis, or increased hair growth on the face or body
• Lower extremity edema (fluid retention) or the swelling of the legs, ankles and/or feet
• Palpitations or tachycardia
• Headaches
• Swelling around the eyes
• Insomnia
• Nausea

If you experience any of the above side effects, contact your provider in order to cease treatment or adjust your dose.

Minoxidil may also cause changes to your EKG; tell your doctor prior to an EKG if you are taking oral minoxidil.

Contraindications:

Do not use oral minoxidil if:

• You are pregnant or breastfeeding
• You have a cardiac history of CHF, hypotension (below 90/60), pulmonary hypertension, kidney or liver disease
• You are taking blood pressure medications for hypertensions
• You have experienced dizziness or fainting that occurs upon standing after sitting or lying down
• You have experienced a sudden onset of muscularity, a deepening of the voice, enlargement of the clitoris or excessive hair growth on the face and body
• You have frontal fibrosing alopecia: If hairline is pushing back (or eyebrow hair loss or skin-colored bumps in the eyebrows, sometimes with associated eyebrow hair loss) with symptoms (itching, burning, dry skin around hair follicle, stinging, erythema)
• You have Alopecia areata
• You have Lichen planopilaris
• You have Ludwig stage II-2 and above
• You have history of pheochromocytoma, a tumor in the adrenal gland
• You have a known allergic reaction to minoxidil

Check with your physician to determine if oral minoxidil is right for you. Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

Drug Interactions

Oral minoxidil has certain drug interactions. It’s important to tell your provider of all the medications you are currently taking, including prescription, over the counter medications, vitamins, and herbal or dietary supplements.

Some medications to what out for include:

• Guanethidine should be discontinued before starting treatment

Seek emergency medical care if you experience any of these side effects:

• Salt and water retention
• Increased heart rate (tachycardia)
• New or worsening chest, arm or shoulder paid
• Shortness of breath
• Dizziness, lightheadedness and fainting
• Sudden changes to your vision or hearing
• Very severe heartburn or signs of indigestion
• A sudden or too large of a drop in blood pressure

This information is not comprehensive. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch. Please see the full Prescribing Information for complete safety information.