"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
Frova Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Frova (frovatriptan succinate) is a headache medicine used to treat migraine headaches. Frova will only treat a headache that has already begun. Frova will not prevent headaches or reduce the number of attacks. Common side effects of Frova include flushing, sensations of tingling/numbness/prickling/heat/warmth under your skin, weakness, stomach upset, dry mouth, drowsiness, dizziness, tired feeling, mild headache (not a migraine), feeling too warm or too cold, bone or joint pain, or pressure or heavy feeling in any part of your body.
The recommended dose is a single tablet of Frova taken orally with fluids. If the headache recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses. The total daily dose of Frova should not exceed 3 tablets (3 x 2.5 mg per day). Frova may interact with propranolol or antidepressants. Other drugs may interact with Frova. Tell your doctor all prescription and over-the-counter medications and supplements you use. Frova should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Frova (frovatriptan succinate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Frova in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using frovatriptan and call your doctor at once if you have a serious side effect such as:
- feeling of pain or tightness in your jaw, neck, or throat;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- sudden and severe stomach pain and bloody diarrhea;
- numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
- (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Less serious side effects may include:
- mild headache (not a migraine);
- feeling too warm or too cold;
- dry mouth, upset stomach;
- bone or joint pain;
- pressure or heavy feeling in any part of your body;
- dizziness, drowsiness, tired feeling; or
- warmth, redness, or mild tingling under your skin.
Read the entire detailed patient monograph for Frova (Frovatriptan Succinate)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Frova Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, hearing changes, mental/mood changes.
Chest/jaw/neck tightness can commonly occur soon after using frovatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction due to a lack of blood flow to the heart, brain, or other parts of the body. Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea, change in the amount of urine.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Frova (Frovatriptan Succinate)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Frova FDA Prescribing Information: Side Effects
The following adverse reactions are described elsewhere in other sections of the labeling:
- Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest, throat, neck and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
- Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
- Medication overuse headache [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Increases in blood pressure [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
FROVA was evaluated in four randomized, double-blind, placebo-controlled, short-term trials. These trials involved 2392 patients (1554 on FROVA 2.5 mg and 838 on placebo). In these short-term trials, patients were predominately female (88%) and Caucasian (94%) with a mean age of 42 years (range 18 -69).The treatment-emergent adverse events that occurred most frequently following administration of FROVA 2.5 mg (i.e., in at least 2% of patients), and at an incidence ≥ 1% greater than with placebo, were dizziness, paresthesia, headache, dry mouth, fatigue, flushing, hot or cold sensation, dyspepsia, skeletal pain, and chest pain. In a long term, open-label study where 496 patients were allowed to treat multiple migraine attacks with FROVA 2.5 mg for up to 1 year, 5% of patients (n=26) discontinued due to treatment-emergent adverse events.
Table 1 lists treatment-emergent adverse events reported within 48 hours of drug administration that occurred with FROVA 2.5 mg at an incidence of ≥ 2% and more often than on placebo, in the four placebo-controlled trials. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these incidence estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.
Table 1 : Treatment-Emergent Adverse Events Reported
within 48 Hours (Incidence ≥ 2% and Greater Than Placebo) of
Patients in Four Pooled Placebo-Controlled Migraine Trials
|Adverse events||FROVA 2.5 mg
|Central & peripheral nervous system|
|Gastrointestinal system disorders|
|Body as a whole - general disorders|
|Hot or cold sensation||3%||2%|
The incidence of adverse events in clinical trials did not increase when up to 3 doses were used within 24 hours. The incidence of adverse events in placebo-controlled clinical trials was not affected by gender, age or concomitant medications commonly used by migraine patients. There were insufficient data to assess the impact of race on the incidence of adverse events.
Other Events Observed in Association with the Administration of FROVA
The incidence of frequently reported adverse events in four placebo-controlled trials are presented below. Events are further classified within body system categories. Frequent adverse events are those occurring in at least 1/100 patients.
Central and peripheral nervous system: dysesthesia and hypoesthesia.
Gastrointestinal: vomiting, abdominal pain and diarrhea.
Body as a whole: pain.
Psychiatric: insomnia and anxiety.
Vision disorders: vision abnormal.
Skin and appendages: sweating increased.
Hearing and vestibular disorders: tinnitus.
Heart rate and rhythm: palpitation.
The following adverse reactions were identified during post approval use of FROVA. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Central and peripheral nervous system: Seizure.
Read the entire FDA prescribing information for Frova (Frovatriptan Succinate)
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