Important Safety Information

What Oral Minoxidil Is Approved For

Minoxidil tablets are an FDA-approved prescription medication. They are approved to treat symptomatic high blood pressure that has not responded to a diuretic plus two other blood-pressure medications.

Using oral minoxidil to treat hair loss is off-label. That means it is being prescribed for a purpose other than the one the FDA approved it for. Off-label prescribing is legal and common, and it is at the discretion of a licensed provider who judges it appropriate for a specific patient. Doses prescribed for hair loss are considerably lower than those used to treat high blood pressure.

Topical minoxidil is a separate product. It is FDA-approved for hair loss and is available without a prescription. The two are not interchangeable, and they should not be used at the same time.

Do Not Use If You:

The labeling for minoxidil tablets lists these contraindications:

• Have a pheochromocytoma, a tumor of the adrenal gland
• Have had an allergic reaction to minoxidil or any of its ingredients

Belle will also not prescribe this treatment if you:

• Are pregnant, trying to become pregnant, or breastfeeding
• Are under 18

Before Taking Oral Minoxidil

Tell your healthcare provider about your full medical history, including if you have:

• Any heart condition, including angina, a previous heart attack, heart failure, or a history of stroke
• Pericarditis or fluid around the heart
• Low blood pressure, or a tendency to feel faint or lightheaded when standing
• Kidney disease, or if you are on dialysis
• Fluid retention or unexplained swelling
• Any other medical conditions or allergies

Also tell your provider about every medication you take, including prescription and over-the-counter medicines, vitamins, herbal products, and dietary supplements. In particular:

• Guanethidine should be stopped before starting minoxidil, because taking them together can cause a severe drop in blood pressure.
• Other blood-pressure medications and diuretics, which can add to minoxidil’s effect on your blood pressure.
• Nitrates and other medicines that lower blood pressure.

Withholding information about your health, or giving inaccurate information in order to obtain treatment, can lead to serious harm.

Pregnancy & Breastfeeding

Belle does not prescribe oral minoxidil for hair loss if you are pregnant, trying to become pregnant, or breastfeeding.

It is worth being precise about where that rule comes from. The labeling for minoxidil tablets does not list pregnancy as a contraindication. It says minoxidil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and that a decision should be made to stop either nursing or the medication, because minoxidil passes into breast milk. That benefit-and-risk weighing is written for treating high blood pressure, where the benefit can be considerable. Treating hair loss is elective, so there is no comparable benefit to weigh against the risk, and Belle treats that as a reason not to prescribe.

• Minoxidil passes into breast milk.
• Tell your provider right away if you become pregnant while taking it.
• If you are being treated for high blood pressure and are pregnant, that is a different decision and one for the provider managing your blood pressure. Do not stop a prescribed medication on your own.

Serious Side Effects: Seek Care Immediately If You Experience:

If you are having a medical emergency, call 911 or go to the nearest emergency room.

• Fluid around the heart (pericardial effusion or tamponade): sharp chest pain, pain spreading to the arm or shoulder, shortness of breath, dizziness, lightheadedness, or fainting
• Worsening chest pain (angina): new chest pain, or chest pain that happens more often or more easily than before
• Rapid heartbeat (tachycardia): an increase of 20 beats per minute or more above your usual resting pulse
• Salt and water retention: rapid weight gain of five pounds or more, or new swelling or puffiness in the face, hands, ankles, or abdomen
• Blood pressure dropping too fast: fainting, severe dizziness, or confusion
• Serious allergic or skin reaction: rash, blistering, peeling skin, or swelling of the face, lips, tongue, or throat

Your provider may ask you to weigh yourself regularly and to check your resting pulse, particularly when you start treatment or change dose.

Unwanted Hair Growth (Hypertrichosis)

The most commonly reported side effect of oral minoxidil is hair growth where you do not want it: longer, thicker, darker hair on the face, arms, back, or legs. It is typically noticed within three to six weeks of starting treatment, is reported more often by women than by men, and becomes more likely at higher doses.

It is generally reversible. Hair growth usually slows and reverses within one to six months of stopping the medication. If it happens, tell your provider rather than adjusting your own dose. They can lower your dose or discuss other options with you.

Common Side Effects

• Unwanted hair growth on the face or body
• Salt and water retention, and swelling in the ankles, legs, or face
• Lightheadedness, dizziness, or low blood pressure, especially when standing up
• A faster heartbeat
• Headache, which often eases over time
• Breast tenderness
• Nausea or vomiting
• Changes on an ECG

This is not a complete list. Contact your provider if any side effect persists, worsens, or concerns you.

How to Take Oral Minoxidil

• Take it exactly as prescribed. It can be taken with or without food.
• Do not change your dose, take extra, or stop and restart without speaking to your provider first.
• Do not use oral and topical minoxidil at the same time. Combining them does not improve results.
• Hair regrowth is maintained only while you continue treatment. Hair regrown with minoxidil is usually lost again over several months after stopping.
• Some extra shedding in the first weeks is common and usually settles within about a month. Tell your care team if it continues.

A Note on Off-Label Prescribing

Once the FDA approves a medication, a licensed provider may prescribe it for a condition other than the approved one when, in their clinical judgment, it is appropriate for that patient. This is called off-label prescribing, and it is a normal part of medical practice. It does mean the FDA has not evaluated minoxidil tablets specifically for the treatment of hair loss, and that the warnings above come from its approved use at higher doses. Your provider will weigh that with you before prescribing.

Emergency Information

• In case of a medical emergency, call 911 or go to the nearest emergency room.
• To report side effects, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
• To reach the Belle care team, text +1-877-359-1724 or call +1-888-541-6003.

This information is not comprehensive. Ask your provider or pharmacist for the full Prescribing Information for complete safety information.