What is Frova used for?

Frova is a prescription medicine used to treat migraine headache attacks in adults. Frova is not used to prevent migraines, or to decrease the number of migraine attacks.
Frova has not been shown to treat headaches called “cluster headaches.”

Who should not take Frova?

Do not take Frova if you: 

• have uncontrolled high blood pressure 
• have heart disease or a history of heart disease 
• have hemiplegic or basilar migraine (if you are not sure about this, ask your health care provider) 
• have had a stroke 
• have circulation (blood flow) problems to your arms, legs, and bowels 
• have taken another migraine medicine in the same drug class as Frova (a serotonin receptor agonist) in the last 24 hours. Ask your health care provider or pharmacist for a list of these medicines. 
• have taken other migraine medicines that contain ergotamine, dihydroergotamine, or methylsergide in the last 24 hours 
• are allergic to Frova or to any of the ingredients in Frova 

What should I tell my health care provider?

Tell your health care provider if you: 

• are pregnant, or planning to become pregnant 
• are breast-feeding or plan to breast-feed 
• have any history of chest pain, shortness of breath, or palpitations 
• have any risk factors for heart disease, including 
  • high blood pressure  
  • diabetes 
  • high cholesterol 
  • overweight
  • smoking 
  • a family history of heart disease
  • past menopause
  • male over 40 years old 
• have any past or present medical problems 
• have allergies to any medicine 

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take: 

• propranolol 
• selective serotonin reuptake inhibitors (SSRIs) such as Prozac (fluoxetine), Luvox (fluvoxamine), Paxil (paroxetine), and Zoloft (sertraline) 

These medicines may affect how Frova works, or Frova may affect how these medicines work. 

What are some possible side effects of Frova? (This is NOT
a complete list of side effects reported with Frova. Your health care provider can
discuss with you a more complete list of side effects.)  

The most common side effects of Frova are: 

• dizziness 
• tiredness 
• headache (other than a migraine headache) 
• paresthesia (feeling of tingling) 
• dry mouth 
• flushing (hot flashes) 
• feeling hot or cold 
• chest pain 
• dyspepsia (indigestion or upset stomach) 
• nausea 
• pain in joints or bones 

For more detailed information about Frova, ask your health care
provider or pharmacist.

http://www.fda.gov/cder/foi/nda/2001/21-006_Frova.htm  Frova’s
Approved Label

Date Posted:  11/22/02