Drug · FAERS side-effect profile with label screen

Frovatriptan side effects: what 772 FDA adverse event reports show

Frovatriptan Succinate · 38 reaction terms · 2,066 drug–reaction co-reports · data 2026-09-14

Drug class

Serotonin (5-ht 1b / 1d ) receptor agonist (triptan)

FDA label, Indications wording of the closest related product

Label matched

Frovatriptan Succinate (Frovatriptan)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

772 reports · 76% serious · 6 with death outcome · 93% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If a patient has no response for the first migraine atta.

FDA label, Indications and Usage

What it is

Frovatriptan succinate tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine 1 (5-HT 1B/1D ) receptor subtype agonist (triptan), as the active ingredient. Frovatriptan succi.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 22 strongest signals

Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 6Not in label — unassessed 9

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 16 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Swollen tongue	203	177.5 157.7–199.9ROR 240.5 · χ² 35,275 / p <1e-300	173.5 EB05 154.4 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 187.6	no trial data cached
Angioedema (deep swelling of face/throat)	201	124.2 110.3–140.0ROR 167.6 · χ² 24,389 / p <1e-300	122.3 EB05 108.7 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 99.3	no trial data cached
Drug ineffective for unapproved indication	212	103.7 92.4–116.3ROR 142.6 · χ² 21,433 / p <1e-300	102.4 EB05 91.3 · IC025 +6.2 3/3 methods agree	Reporting / coding artifact	serious PRR 173.0	no trial data cached
Dysphonia	200	93.3 82.8–105.2ROR 125.6 · χ² 18,159 / p <1e-300	92.2 EB05 82.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 133.1	no trial data cached
Swelling face	203	85.1 75.6–95.7ROR 115.0 · χ² 16,777 / p <1e-300	84.1 EB05 74.9 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 105.5	no trial data cached
Extrapyramidal disorder	55	59.7 46.2–77.0ROR 64.2 · χ² 3,112 / p <1e-300	58.4 EB05 46.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 50.2 · 91% clinician	no trial data cached
Drug intolerance	209	59.1 52.6–66.4ROR 80.7 · χ² 11,910 / p <1e-300	58.7 EB05 52.3 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 72.6	no trial data cached
Migraine	127	36.4 31.1–42.7ROR 43.4 · χ² 4,352 / p <1e-300	36.2 EB05 31.2 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 45.1	no trial data cached
Sputum discoloured	11	31.6 17.6–56.9ROR 32.1 · χ² 296 / p 1e-66	30.1 EB05 17.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 28.5	no trial data cached
Hypersensitivity (allergic reaction)	210	30.8 27.4–34.6ROR 41.9 · χ² 6,073 / p <1e-300	30.7 EB05 27.4 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 43.4	no trial data cached
Eye haemorrhage	11	22.4 12.4–40.2ROR 22.7 · χ² 204 / p 2e-46	21.3 EB05 12.2 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.0	no trial data cached
Therapy partial responder	12	21.7 12.4–38.0ROR 22.0 · χ² 216 / p 3e-49	20.8 EB05 12.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 16.6	no trial data cached
Treatment failure	59	19.5 15.3–25.0ROR 21.1 · χ² 1,023 / p 1e-224	19.4 EB05 15.6 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 27.0	no trial data cached
Seasonal allergy	10	19.3 10.4–35.6ROR 19.5 · χ² 155 / p 6e-36	18.0 EB05 9.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Diplopia (double vision)	16	16.7 10.3–27.2ROR 17.1 · χ² 221 / p 2e-50	16.1 EB05 10.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached
Dyspepsia (indigestion)	56	15.5 12.1–20.0ROR 16.6 · χ² 749 / p 3e-165	15.4 EB05 12.2 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.0	no trial data cached
Product use in unapproved indication	118	13.1 11.1–15.5ROR 15.3 · χ² 1,325 / p 3e-290	13.0 EB05 11.2 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 21.7	no trial data cached
Throat tightness	11	11.1 6.2–19.9ROR 11.2 · χ² 91 / p 7e-22	9.2 EB05 4.9 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.0	no trial data cached
Withdrawal syndrome	11	7.1 3.9–12.7ROR 7.2 · χ² 52 / p 3e-13	5.7 EB05 3.3 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.0	no trial data cached
Foetal exposure during pregnancy	16	5.3 3.3–8.7ROR 5.4 · χ² 53 / p 2e-13	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9	no trial data cached
Injection site bruising	12	4.1 2.4–7.2ROR 4.2 · χ² 26 / p 2e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached
Injection site swelling	11	3.9 2.2–7.1ROR 4.0 · χ² 21 / p 2e-6	3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug ineffective for unapproved indication	212	103.7 92.4–116.3ROR 142.6 · χ² 21,433 / p <1e-300	102.4 EB05 91.3 · IC025 +6.2 3/3 methods agree	Reporting / coding artifact	serious PRR 173.0	no trial data cached
Hypersensitivity (allergic reaction)	210	30.8 27.4–34.6ROR 41.9 · χ² 6,073 / p <1e-300	30.7 EB05 27.4 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 43.4	no trial data cached
Drug intolerance	209	59.1 52.6–66.4ROR 80.7 · χ² 11,910 / p <1e-300	58.7 EB05 52.3 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 72.6	no trial data cached
Swelling face	203	85.1 75.6–95.7ROR 115.0 · χ² 16,777 / p <1e-300	84.1 EB05 74.9 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 105.5	no trial data cached
Swollen tongue	203	177.5 157.7–199.9ROR 240.5 · χ² 35,275 / p <1e-300	173.5 EB05 154.4 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 187.6	no trial data cached
Angioedema (deep swelling of face/throat)	201	124.2 110.3–140.0ROR 167.6 · χ² 24,389 / p <1e-300	122.3 EB05 108.7 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 99.3	no trial data cached
Dysphonia	200	93.3 82.8–105.2ROR 125.6 · χ² 18,159 / p <1e-300	92.2 EB05 82.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 133.1	no trial data cached
Migraine	127	36.4 31.1–42.7ROR 43.4 · χ² 4,352 / p <1e-300	36.2 EB05 31.2 · IC025 +4.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 45.1	no trial data cached
Product use in unapproved indication	118	13.1 11.1–15.5ROR 15.3 · χ² 1,325 / p 3e-290	13.0 EB05 11.2 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 21.7	no trial data cached
Treatment failure	59	19.5 15.3–25.0ROR 21.1 · χ² 1,023 / p 1e-224	19.4 EB05 15.6 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 27.0	no trial data cached
Dyspepsia (indigestion)	56	15.5 12.1–20.0ROR 16.6 · χ² 749 / p 3e-165	15.4 EB05 12.2 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.0	no trial data cached
Extrapyramidal disorder	55	59.7 46.2–77.0ROR 64.2 · χ² 3,112 / p <1e-300	58.4 EB05 46.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 50.2 · 91% clinician	no trial data cached
Foetal exposure during pregnancy	16	5.3 3.3–8.7ROR 5.4 · χ² 53 / p 2e-13	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9	no trial data cached
Diplopia (double vision)	16	16.7 10.3–27.2ROR 17.1 · χ² 221 / p 2e-50	16.1 EB05 10.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached
Injection site bruising	12	4.1 2.4–7.2ROR 4.2 · χ² 26 / p 2e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.4	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Swollen tongue — n=203, PRR 177.5
Dysphonia — n=200, PRR 93.3
Swelling face — n=203, PRR 85.1
Extrapyramidal disorder — n=55, PRR 59.7

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Frovatriptan?

In FDA FAERS, the most frequently co-reported reaction terms for Frovatriptan are hypersensitivity, swelling face, swollen tongue, angioedema, dysphonia, migraine. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Frovatriptan have an FDA boxed warning?

No. The FDA label retrieved for Frovatriptan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Frovatriptan causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 94b996dc-ddc4-41ce-9a9f-3d91cb187473, effective 20190930; matched on openfda.generic_name.exact:"FROVATRIPTAN SUCCINATE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 38 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.