Frova is a headache medicine that narrows blood vessels around the brain. This medicine also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Frova is used to treat migraine headaches. This medicine will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Frova should not be used to treat a common tension headache, or a headache that causes loss of movement on one side of your body. Use Frova only if your condition has been confirmed by a doctor as migraine headaches.

Frova may also be used for purposes not listed in this medication guide.

You should not use Frova if you have ever had heart disease, coronary artery disease, blood circulation problems, Wolff-Parkinson-White syndrome, uncontrolled high blood pressure, severe liver disease, a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches.

Do not take Frova within 24 hours before or after using another migraine headache medicine.

You may receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Take Frova as soon as you notice headache symptoms. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Take 1 tablet whole with a full glass of water.

After taking a tablet: If your headache does not completely go away, call your doctor before taking a second tablet. If your headache goes away and then comes back, take a second tablet if it has been at least 2 hours since your first tablet. Do not take more than 3 tablets in 24 hours.

Call your doctor if your headache does not go away at all after taking the first Frova tablet.

Tell your doctor if you have more than four headaches in one month (30 days). Tell your doctor if this medicine seems to stop working as well in treating your migraine attacks.

Store at room temperature away from moisture and heat.

You should not use Frova if you are allergic to it, if you have a headache that seems different from your usual migraine headaches, or if you have ever had:

• heart problems, or a stroke (including "mini-stroke");

• coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

• circulation problems affecting your legs, arms, stomach, intestines, or kidneys;

• a heart disorder called Wolff-Parkinson-White syndrome;

• uncontrolled high blood pressure; or

• severe liver disease.

Tell your doctor if you have ever had:

• liver or kidney disease;

• high blood pressure, a heart rhythm disorder; or

• risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, or being older than 40 and a man).

It is not known whether Frova will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Frova is not approved for use by anyone younger than 18 years old.

Since Frova is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using Frova.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not take Frova within 24 hours before or after using another migraine headache medicine, including:

• sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan, zolmitriptan; or

• ergot medicine such as dihydroergotamine, ergotamine, ergonovine, or methylergonovine.

Avoid driving or hazardous activity until you know how Frova will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Frova may cause serious side effects. Stop using Frova and call your doctor at once if you have:

• sudden and severe stomach pain and bloody diarrhea;

• severe chest pain, shortness of breath, irregular heartbeats;

• a seizure (convulsions);

• blood circulation problems in your legs or feet--cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects of Frova may include:

• mild headache (not a migraine);

• feeling too warm or too cold;

• dry mouth, upset stomach;

• chest pain;

• bone or joint pain;

• numbness or tingling in your fingers or toes;

• dizziness, tiredness; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using Frova while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• medicine to treat depression or a psychiatric disorder;

• medicine for Parkinson's disease;

• medicine for serious infections;

• herbal products;

• stimulant medicine;

• opioid medicine; or

• medicine to prevent nausea and vomiting.

This list is not complete. Other drugs may affect Frova, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.