What the label lists and what reports show
Frovatriptan side effects
Frovatriptan's FDA label: “Most common adverse reactions (≥2% and >placebo) were dizziness, headache, paresthesia, dry mouth, dyspepsia, fatigue, hot or cold sensation, chest pain, skeletal pain, and flushing (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at …” FAERS holds 772 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypersensitivity (210 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the frovatriptan FDA label on DailyMed (effective June 27, 2026, Leading Pharma, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of frovatriptan succinate tablets?Frovatriptan succinate tablets can cause serious side effects. See “What is the most important information I should know about frovatriptan succinate tablets?” Stroke. Stop taking frovatriptan succinate tablets and get emergency medical help right away if you have any of the following symptoms of a stroke: face drooping slurred speech unusual weakness or numbness Changes in color or sensation in your fingers and toes (Raynaud’ssyndrome) Stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain stomach pain after meals weight loss nausea or vomiting constipation or diarrhea bloody diarrhea fever Problems with blood circulation to your legs and feet (peripheral vascular ischemia). […]
Source: FDA drug label, Leading Pharma, LLC, effective June 27, 2026 (SPL set d303af88-e0c1-4fb2-ba8e-83b7e6d163cd), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥2% and >placebo) were dizziness, headache, paresthesia, dry mouth, dyspepsia, fatigue, hot or cold sensation, chest pain, skeletal pain, and flushing (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1: Adverse Reactions Reported within 48 Hours (Incidence ≥2% and Greater Than Placebo) of Patients in Four Pooled Placebo-Controlled Migraine Trials
| Reaction | Frovatriptan 2.5 mg (n=1554) 8% 4% 4% 3% 2% | Placebo (n=838) 5% 3% 2% 1% 1% |
|---|---|---|
| Body as a whole – general disorders | 5% | 2% |
| Fatigue | 3% | 2% |
| Hot or cold sensation Chest pain | 2% | 1% |
| Musculo-skeletal | 3% | 2% |
| Vascular | 4% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina [see Warnings and Precautions (5.1) ] Arrhythmias [see Warnings and Precautions (5.2) ] Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ] Cerebrovascular Events [see Warnings and Precautions (5.4) ] Other Vasospasm Reactions [see Warnings and Precautions (5.5) ] Medication Overuse Headache [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Increases in Blood Pressure [see Warnings and Precautions (5.8) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.9) ] Most common adverse reactions (≥2% and >placebo) were dizziness, headache, paresthesia, dry mouth, dyspepsia, fatigue, hot or cold sensation, chest pain, skeletal pain, and flushing (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. …
Source: FDA drug label, Leading Pharma, LLC, effective June 27, 2026 (SPL set d303af88-e0c1-4fb2-ba8e-83b7e6d163cd), via openFDA; the full label on DailyMed
What do FAERS reports show?
772 reports list frovatriptan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 134 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Frovatriptan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions