Drug · FAERS side-effect profile with label screen

Sumatriptan and Naproxen side effects: what 1,423 FDA adverse event reports show

Sumatriptan Succinate And Naproxen Sodium · 30 reaction terms · 368 drug–reaction co-reports · data 2026-09-14

Drug class

Serotonin-1b and Serotonin-1d Receptor Agonist

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Sumatriptan (Tosymra)

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

Who reports

1,423 reports · 33% serious · 24 with death outcome · 88% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of U.

FDA label, Indications and Usage

What it is

TOSYMRA contains sumatriptan, a selective 5-HT 1B/1D receptor agonist. Sumatriptan is chemically designated as 1-[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]- N -methylmethanesulfonamide, and it has the following structure:

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 1Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 6Not in label — unassessed 10

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. 8 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
Muscle tightness	18	16.4 10.4–26.0ROR 16.6 · χ² 246 / p 1e-55	15.9 EB05 10.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Throat tightness	28	15.3 10.6–22.1ROR 15.6 · χ² 360 / p 1e-80	15.0 EB05 10.6 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.3 · 92% consumer	no trial data cached
Migraine	93	14.5 11.9–17.6ROR 15.4 · χ² 1,158 / p 5e-254	14.4 EB05 12.1 · IC025 +3.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 19.8 · 76% consumer	no trial data cached
Gallbladder disorder	11	9.1 5.0–16.3ROR 9.1 · χ² 71 / p 2e-17	7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.9	no trial data cached
Foot fracture	11	8.5 4.7–15.4ROR 8.6 · χ² 66 / p 2e-16	6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Nephropathy	5	7.9 3.3–18.9ROR 7.9 · χ² 23 / p 6e-7	5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.7	no trial data cached
Pain in jaw	14	7.3 4.3–12.3ROR 7.4 · χ² 70 / p 3e-17	6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.0	no trial data cached
Drug administration error	15	7.1 4.3–11.8ROR 7.2 · χ² 73 / p 7e-18	6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5	no trial data cached
Serotonin syndrome	9	6.9 3.6–13.3ROR 7.0 · χ² 40 / p 1e-10	5.4 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.3	no trial data cached
Fibromyalgia	11	6.7 3.7–12.0ROR 6.7 · χ² 48 / p 3e-12	5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Product physical issue	9	6.7 3.5–12.8ROR 6.7 · χ² 38 / p 4e-10	5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Pharyngeal oedema	7	6.6 3.2–13.9ROR 6.7 · χ² 28 / p 6e-8	4.9 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Sensory disturbance	7	6.4 3.1–13.4ROR 6.4 · χ² 27 / p 1e-7	4.7 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial data cached
Application site irritation	5	5.9 2.5–14.2ROR 5.9 · χ² 16 / p 3e-5	4.1 EB05 1.9 · IC025 +0.5	Labeled (related wording) related wording	serious n=3	no trial data cached
Drug effect decreased	19	5.1 3.3–8.0ROR 5.2 · χ² 59 / p 7e-15	4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2	no trial data cached
Impaired work ability	7	4.8 2.3–10.1ROR 4.8 · χ² 18 / p 1e-5	3.8 EB05 2.0 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.1	no trial data cached
Therapeutic response unexpected	14	4.6 2.7–7.7ROR 4.6 · χ² 36 / p 1e-9	4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5	no trial data cached
Wrong technique in drug usage process	11	4.4 2.4–7.9ROR 4.4 · χ² 26 / p 2e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.0	no trial data cached
Application site erythema	7	3.9 1.9–8.2ROR 3.9 · χ² 12 / p 2e-4	3.2 EB05 1.7 · IC025 +0.4	Labeled (related wording) related wording	serious n=4	no trial data cached
Injection site urticaria	6	3.7 1.6–8.1ROR 3.7 · χ² 9 / p 0.001	3.0 EB05 1.5 · IC025 +0.2	Not in label — unassessed	serious n=2	no trial data cached
Drug effect incomplete	7	2.8 1.3–5.9ROR 2.8 · χ² 6 / p 0.006	2.5 EB05 1.3 · IC025 +0.0	Reporting / coding artifact	serious PRR 11.1	no trial data cached
Multiple sclerosis	8	2.5 1.2–4.9ROR 2.5 · χ² 6 / p 0.009	2.3 EB05 1.3 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 4.0	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
Migraine	93	14.5 11.9–17.6ROR 15.4 · χ² 1,158 / p 5e-254	14.4 EB05 12.1 · IC025 +3.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 19.8 · 76% consumer	no trial data cached
Throat tightness	28	15.3 10.6–22.1ROR 15.6 · χ² 360 / p 1e-80	15.0 EB05 10.6 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.3 · 92% consumer	no trial data cached
Drug effect decreased	19	5.1 3.3–8.0ROR 5.2 · χ² 59 / p 7e-15	4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2	no trial data cached
Muscle tightness	18	16.4 10.4–26.0ROR 16.6 · χ² 246 / p 1e-55	15.9 EB05 10.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Drug administration error	15	7.1 4.3–11.8ROR 7.2 · χ² 73 / p 7e-18	6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.5	no trial data cached
Therapeutic response unexpected	14	4.6 2.7–7.7ROR 4.6 · χ² 36 / p 1e-9	4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5	no trial data cached
Pain in jaw	14	7.3 4.3–12.3ROR 7.4 · χ² 70 / p 3e-17	6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.0	no trial data cached
Wrong technique in drug usage process	11	4.4 2.4–7.9ROR 4.4 · χ² 26 / p 2e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.0	no trial data cached
Fibromyalgia	11	6.7 3.7–12.0ROR 6.7 · χ² 48 / p 3e-12	5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Foot fracture	11	8.5 4.7–15.4ROR 8.6 · χ² 66 / p 2e-16	6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Gallbladder disorder	11	9.1 5.0–16.3ROR 9.1 · χ² 71 / p 2e-17	7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.9	no trial data cached
Completed suicide (death by suicide)	10	1.8 0.9–3.3ROR 1.8 · χ² 3 / p 0.056	1.7 EB05 1.0 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	serious PRR 3.1	no trial data cached
Injection site bruising	10	1.9 1.0–3.5ROR 1.9 · χ² 3 / p 0.036	1.8 EB05 1.1 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 4.0	no trial data cached
Product physical issue	9	6.7 3.5–12.8ROR 6.7 · χ² 38 / p 4e-10	5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Serotonin syndrome	9	6.9 3.6–13.3ROR 7.0 · χ² 40 / p 1e-10	5.4 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.3	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Sumatriptan and Naproxen?

In FDA FAERS, the most frequently co-reported reaction terms for Sumatriptan and Naproxen are migraine, throat tightness, muscle tightness, pain in jaw, fibromyalgia, foot fracture. 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 Sumatriptan and Naproxen have an FDA boxed warning?

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

Do FAERS signals prove that Sumatriptan and Naproxen 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 015a5cf9-f246-48bc-b91e-cd730a53d8aa, effective 20241118; matched on openfda.generic_name.exact:"SUMATRIPTAN")
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, 30 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.