Oral Minoxidil

Drug Safety Information

You must always read this safety information prior to starting this medication and whenever you get a refill. There may be new information. This information is not a substitute for discussing your medical condition or treatment with your healthcare provider

This product has not been approved by the FDA for hair loss. It is only available if prescribed by a dermatologist  through Tangl who will determine if treatment is suitable. 

What I need to know about Oral Minoxidil:  

Oral minoxidil is FDA-approved for high blood pressure treatment for patients unresponsive to other blood pressure treatments. For hair loss, dermatologists may prescribe it “off-label” in low doses. While it has been observed to promote hair growth, its FDA approval and long term safety data pertains to blood pressure management.

Absolute Contraindications – DO NOT use oral minoxidil if you: 

• Are allergic to oral minoxidil 
• Are under 18 or haven't completed menopause
• Are pregnant, breastfeeding, or planning a pregnancy 
• Have a history of cancer, heart failure, kidney problems or liver problems
• Have any present or past heart conditions like arrhythmias (abnormal heart rhythms), angina (ongoing chest pain), carditis, cardiomyopathy, heart valve disease, stroke, heart attack, congenital heart disease, aortic aneurysms, peripheral artery disease, EKG abnormalities, or other vascular conditions.
• Have high/low blood pressure or orthostatic hypotension
• Have any pulmonary, endocrine (thyroid/adrenal), rheumatological (bone/joint) or GI conditions such as pulmonary hypertension, hyperthyroidism, Addison’s disease, pheochromocytoma, lupus, rheumatoid arthritis, osteoarthritis, gastric ulcers, ulcerative colitis, GI bleeding, or other conditions. 

Drug Interactions – DO NOT use oral minoxidil if you take: 

• Lithium
• Guanethidine
• Certain blood pressure medications (see a doctor in-person about seeking treatment with oral minoxidil)  

Serious Side Effects – STOP treatment and seek emergency medical care or call 911 if you experience:  

• Chest pain or tightness 
• Shortness of breath or difficulty breathing 
• Rapid heart rate or heart palpitations (irregular heartbeats)  
• Swelling in the face, hands, legs, feet or ankles 
• Rapid weight gain or fluid retention (edema) 
• Significant or sudden drop in blood pressure
• Dizziness, lightheadedness or fainting 
• Severe skin rashes 
• Vomiting, severe heartburn/indigestion or bleeding 

It’s important to closely and regularly monitor for these side effects while taking oral minoxidil, especially when starting or changing your dose, as they can indicate a severe reaction. If you notice any, stop taking oral minoxidil and seek immediate medical attention, or call 911. 

Common Side Effects  – Talk to your provider about changing your dose/treatment if you experience: 

• Unwanted hair growth on the face or body (hypertrichosis) 
• Headache    
• Insomnia 
• Nausea 
• Hair shedding: It's common to experience increased hair shedding initially. This is typically a temporary phase as hair follicles regenerate. 
• Some may also experience changes in hair texture and color. 

These are not all of the possible side effects of oral minoxidil. For more information, ask your healthcare provider or pharmacist and refer to the full prescribing information for minoxidil.  

WARNING: SERIOUS CARDIAC EFFECTS
Oral minoxidil can lead to severe cardiovascular side effects. Pericardial effusions, which is the excessive buildup of fluid in the sac surrounding the heart (pericardium), have been reported in patients taking oral minoxidil. This can progress to cardiac tamponade, which is a life-threatening condition where the fluid pressure compresses the heart, preventing it from effectively pumping blood. Symptoms encompass sharp chest pain and breathing difficulties. If you notice these symptoms, seek immediate emergency medical care.

Animal Testing Results: During animal testing, minoxidil was found to cause cardiac lesions and other harmful heart effects. Although animal findings don't always reflect human responses, Tangl dermatologists adhere to a principle of caution when prescribing. Due to its potential cardiac implications and concerns arising from animal studies related to cancer, you should not use oral minoxidil if you have any heart conditions, a history of major cardiac events, or a history and/or risk of cancer. 

Always use oral minoxidil under the supervision of a healthcare professional and undergo regular medical assessments during treatment.

WARNING: TOXIC TO PETS  

• Minoxidil is highly toxic to animals, especially cats; even trace amounts can be life-threatening. 
• Always store minoxidil in a secure location out of reach of pets. 
• If you suspect your pet has come into contact with minoxidil or displays symptoms such as lethargy, rapid breathing, vomiting, or collapse, seek emergency veterinary care immediately.

Always Inform Medical Professionals:

•  Always consult a healthcare provider immediately about any unusual side effects, concerns or changes noticed during treatment.
• Minoxidil may cause changes to your EKG; always inform your doctor that you are taking oral minoxidil before an EKG or before starting any new medication. 
• You can message your Tangl dermatologist through your Tangl account (trytangl.com/account) if you have any questions or concerns about your treatment.  

Always Provide Accurate Health Information: Failing to provide accurate information about your health and medical history can lead to severe consequences, including harm or, in some instances, death.

Report Side Effects to the FDA: Negative side effects should be reported to the FDA at www.fda.gov/medwatch  or call 1-800-FDA-1088.

Disclaimer: The FDA has not evaluated all the claims made here. This medication is not guaranteed to diagnose, treat, cure, or prevent any disease. Individual results may vary.

This information is not comprehensive. Please see the full prescribing link below for complete safety information: Oral Minoxidil