Drug · FAERS side-effect profile with label screen
Sumatriptan Succinate side effects: what 25,117 FDA adverse event reports show
Drug class
Serotonin-1b and Serotonin-1d Receptor Agonist
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Tosymra
openFDA label
Who reports
25,117 reports · 58% serious · 768 with death outcome · 83% 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 40 strongest signals
Labeled adverse reaction 2Likely indication confounding 5Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 29
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.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,123 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cervicogenic headache | 21 | 155.6 97.6–248.0ROR 155.7 · calibrated p 2e-8 ✓ | 117.3 EB05 80.9 · IC025 +4.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | not reported in cached trials |
| Medication overuse headache | 130 | 149.8 124.3–180.5ROR 150.5 · calibrated p 6e-9 ✓ | 124.6 EB05 107.6 · IC025 +6.1 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.6–2.5) | Labeled adverse reaction exact term | serious n=107 | not reported in cached trials |
| Iiird nerve paresis | 27 | 143.3 95.2–215.6ROR 143.4 · calibrated p 2e-8 ✓ | 112.6 EB05 81.3 · IC025 +4.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.3–3.7) | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Postnatal growth restriction | 15 | 124.6 72.4–214.5ROR 124.7 · calibrated p 2e-7 ✓ | 95.5 EB05 61.5 · IC025 +3.7 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Pineal gland cyst | 17 | 114.6 69.0–190.3ROR 114.7 · calibrated p 2e-7 ✓ | 90.7 EB05 60.0 · IC025 +3.9 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Migraine without aura | 30 | 93.1 63.8–135.8ROR 93.2 · calibrated p 5e-7 ✓ | 79.6 EB05 58.5 · IC025 +4.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.6 (1.5–4.5) | Likely indication confounding term in indications | serious n=29 | not reported in cached trials |
| Drug specific antibody | 85 | 55.4 44.5–69.0ROR 55.6 · calibrated p 9e-6 ✓ | 51.4 EB05 42.9 · IC025 +5.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 4.7 (3.2–7.0) | Lab value / disease marker | serious n=85 | not reported in cached trials |
| Coronary artery dissection | 51 | 53.6 40.4–71.1ROR 53.7 · calibrated p 1e-5 ✓ | 49.5 EB05 39.1 · IC025 +4.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.9 (1.3–2.8) | Not in label — unassessed | serious n=51 · 100% clinician | not reported in cached trials |
| Reversible cerebral vasoconstriction syndrome | 115 | 51.9 43.0–62.7ROR 52.1 · calibrated p 1e-5 ✓ | 48.5 EB05 41.5 · IC025 +5.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.7–2.9) | Not in label — unassessed | serious n=115 · 100% clinician | not reported in cached trials |
| Soft tissue injury | 42 | 48.9 35.8–66.8ROR 49.0 · calibrated p 2e-5 ✓ | 45.4 EB05 35.0 · IC025 +4.4 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 3.4 (2.0–5.5) | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Post-traumatic neck syndrome | 45 | 48.8 36.2–65.9ROR 48.9 · calibrated p 2e-5 ✓ | 45.3 EB05 35.3 · IC025 +4.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.8 (1.8–4.4) | Not in label — unassessed | serious n=44 · 100% clinician | not reported in cached trials |
| Cluster headache | 64 | 41.2 32.0–52.9ROR 41.3 · calibrated p 6e-5 ✓ | 38.8 EB05 31.5 · IC025 +4.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.8 (1.3–2.6) | Likely indication confounding term in indications | serious n=38 · ♀ 44% (drug 83%) | not reported in cached trials |
| Cerebral vasoconstriction | 25 | 29.2 19.6–43.5ROR 29.2 · calibrated p 5e-4 ✓ | 27.7 EB05 19.7 · IC025 +3.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Sternal fracture | 41 | 28.7 21.0–39.1ROR 28.7 · calibrated p 4e-4 ✓ | 27.4 EB05 21.1 · IC025 +3.9 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.9 (1.8–4.7) | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Arteriospasm coronary | 117 | 25.5 21.2–30.6ROR 25.6 · calibrated p 7e-4 ✓ | 24.7 EB05 21.1 · IC025 +4.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.6 (1.3–2.1) | Not in label — unassessed | serious n=117 · ♀ 52% (drug 83%) · 94% clinician | not reported in cached trials |
| Vasospasm | 24 | 22.4 15.0–33.6ROR 22.5 · calibrated p 0.002 ✓ | 21.5 EB05 15.2 · IC025 +3.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.7 (1.0–2.8) | Labeled adverse reaction exact term | serious n=24 · 100% clinician | not reported in cached trials |
| Endometriosis | 124 | 22.2 18.6–26.6ROR 22.4 · calibrated p 0.001 ✓ | 21.6 EB05 18.6 · IC025 +4.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.8 (2.1–3.6) | Not in label — unassessed | serious n=122 | NCT00898677: 1/164 (0.6%) on Sumatriptan Succinate (serious AE) |
| Renal aplasia | 18 | 21.8 13.6–34.8ROR 21.8 · calibrated p 0.002 ✓ | 20.8 EB05 13.7 · IC025 +3.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Product ineffective for unapproved use | 33 | 20.2 14.3–28.5ROR 20.2 · calibrated p 0.003 ✓ | 19.5 EB05 14.5 · IC025 +3.4 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Reporting / coding artifact | serious n=32 | not reported in cached trials |
| Pulmonary artery stenosis congenital | 17 | 19.7 12.2–31.9ROR 19.7 · calibrated p 0.004 ✓ | 18.8 EB05 12.1 · IC025 +2.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Device deployment issue | 277 | 19.7 17.5–22.2ROR 19.9 · calibrated p 0.002 ✓ | 19.2 EB05 17.4 · IC025 +4.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.7–2.3) | Reporting / coding artifact | – | not reported in cached trials |
| Foetal heart rate abnormal | 21 | 19.3 12.6–29.8ROR 19.4 · calibrated p 0.004 ✓ | 18.5 EB05 12.6 · IC025 +3.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Lab value / disease marker | serious n=21 · 100% clinician | not reported in cached trials |
| Drug-disease interaction | 16 | 19.2 11.7–31.5ROR 19.2 · calibrated p 0.004 ✓ | 18.2 EB05 11.5 · IC025 +2.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Brugada syndrome | 23 | 19.2 12.7–29.0ROR 19.2 · calibrated p 0.004 ✓ | 18.4 EB05 12.8 · IC025 +3.1 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=23 · ♀ 0% (drug 83%) · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 31 | 18.9 13.3–27.0ROR 19.0 · calibrated p 0.003 ✓ | 18.3 EB05 13.4 · IC025 +3.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Transient global amnesia | 16 | 18.7 11.4–30.8ROR 18.8 · calibrated p 0.005 ✓ | 17.8 EB05 11.2 · IC025 +2.7 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Neonatal respiratory distress | 18 | 17.7 11.1–28.2ROR 17.7 · calibrated p 0.005 ✓ | 16.8 EB05 10.9 · IC025 +2.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Central obesity | 15 | 17.4 10.5–29.1ROR 17.4 · calibrated p 0.006 ✓ | 16.4 EB05 10.0 · IC025 +2.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Extensor plantar response | 19 | 17.4 11.1–27.4ROR 17.4 · calibrated p 0.006 ✓ | 16.6 EB05 10.9 · IC025 +2.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Libido increased | 40 | 16.8 12.3–22.9ROR 16.8 · calibrated p 0.005 ✓ | 16.3 EB05 12.4 · IC025 +3.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 3.5 (2.1–5.8) | Not in label — unassessed | serious n=40 · 100% clinician | not reported in cached trials |
| Pituitary tumour benign | 32 | 16.6 11.7–23.5ROR 16.6 · calibrated p 0.006 ✓ | 16.0 EB05 11.7 · IC025 +3.1 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.2–3.3) | Not in label — unassessed | serious n=32 · 100% clinician | not reported in cached trials |
| Migraine | 1,843 | 16.5 15.8–17.3ROR 17.7 · calibrated p 0.003 ✓ | 16.2 EB05 15.6 · IC025 +3.9 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.0 (0.9–1.0) | Likely indication confounding term in indications; also in warnings | serious PRR 19.6 | not reported in cached trials |
| Postural orthostatic tachycardia syndrome | 25 | 16.2 10.9–24.1ROR 16.2 · calibrated p 0.007 ✓ | 15.6 EB05 10.8 · IC025 +3.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Microcephaly | 24 | 16.1 10.7–24.1ROR 16.1 · calibrated p 0.007 ✓ | 15.4 EB05 10.6 · IC025 +2.9 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.3 (1.3–4.1) | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Colitis ischaemic | 126 | 15.9 13.4–19.0ROR 16.0 · calibrated p 0.006 ✓ | 15.6 EB05 13.4 · IC025 +3.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.1 (1.7–2.7) | Not in label — unassessed | serious n=126 · 90% clinician | not reported in cached trials |
| Clonus | 51 | 15.8 12.0–20.8ROR 15.8 · calibrated p 0.006 ✓ | 15.4 EB05 12.1 · IC025 +3.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.5–3.2) | Not in label — unassessed | serious n=50 · 100% clinician | not reported in cached trials |
| Renal infarct | 27 | 15.7 10.8–23.0ROR 15.8 · calibrated p 0.008 ✓ | 15.1 EB05 10.7 · IC025 +3.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.3–3.9) | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Craniosynostosis | 16 | 15.6 9.5–25.6ROR 15.6 · calibrated p 0.009 ✓ | 14.6 EB05 8.9 · IC025 +2.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: only this drug | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Migraine with aura | 46 | 14.4 10.7–19.2ROR 14.4 · calibrated p 0.010 ✓ | 13.9 EB05 10.8 · IC025 +3.1 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.4 (1.0–2.0) | Likely indication confounding term in indications | serious n=36 | not reported in cached trials |
| Binge eating | 18 | 14.2 8.9–22.6ROR 14.2 · calibrated p 0.013 ✓ | 13.2 EB05 8.3 · IC025 +2.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.8 (1.0–3.4) | Not in label — unassessed | serious n=18 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Sumatriptan Succinate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT00898677 — Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) (N=1268, PHASE3; 44 AE terms posted; arms: Rizatriptan 5 mg; Rizatriptan 10 mg; Sumatriptan 100 mg; Placebo)
- NCT01430442 — Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine (N=1026, PHASE2; 5 AE terms posted; arms: Treatment A: Rimegepant, 10 mg; Treatment B: Rimegepant, 25 mg; Treatment C: Rimegepant, 75 mg; Treatment D: Rimegepant, 150 mg)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 (drug did not work) | 2,848 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.894 | 1.8 EB05 1.7 · IC025 +0.8 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 0.9 (0.9–1.0) | Reporting / coding artifact | serious PRR 2.2 | not reported in cached trials |
| Headache | 2,158 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.607 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.0 (1.0–1.1) | Likely indication confounding term in indications; also in warnings | serious PRR 3.9 | NCT00898677: 11/388 (2.8%) on Sumatriptan Succinate; 2/160 (1.2%) control |
| Migraine | 1,843 | 16.5 15.8–17.3ROR 17.7 · calibrated p 0.003 ✓ | 16.2 EB05 15.6 · IC025 +3.9 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.0 (0.9–1.0) | Likely indication confounding term in indications; also in warnings | serious PRR 19.6 | not reported in cached trials |
| Nausea | 1,786 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.922 | 1.9 EB05 1.8 · IC025 +0.8 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.0 (1.0–1.1) | Labeled adverse reaction exact term | serious PRR 2.4 | NCT00898677: 35/388 (9.0%) on Sumatriptan Succinate; 4/160 (2.5%) control |
| Fatigue (tiredness) | 1,497 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.737 | 1.6 EB05 1.5 · IC025 +0.6 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.1 (1.1–1.2) | Not in label — unassessed | serious PRR 1.9 | NCT00898677: 32/388 (8.2%) on Sumatriptan Succinate; 6/160 (3.8%) control |
| Dizziness | 1,208 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.987 | 2.0 EB05 1.9 · IC025 +0.9 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.2 (1.1–1.3) | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00898677: 35/388 (9.0%) on Sumatriptan Succinate; 6/160 (3.8%) control |
| Off label use (used outside approved label) | 1,176 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.398 | 1.1 EB05 1.1 · IC025 +0.1 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.3 (1.2–1.4) | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Pain | 1,176 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.723 | 1.6 EB05 1.5 · IC025 +0.6 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.0 (0.9–1.0) | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00898677: 20/388 (5.2%) on Sumatriptan Succinate; 2/160 (1.2%) control |
| Product dose omission issue | 1,010 | 3.0 2.8–3.2ROR 3.0 · calibrated p 0.611 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.8 (2.5–3.1) | Reporting / coding artifact | serious PRR 2.2 · 79% consumer | not reported in cached trials |
| Vomiting | 953 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.785 | 1.7 EB05 1.6 · IC025 +0.7 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.0 (0.9–1.0) | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00898677: 10/388 (2.6%) on Sumatriptan Succinate; 8/160 (5.0%) control |
| Dyspnoea (shortness of breath) | 937 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.574 | 1.4 EB05 1.3 · IC025 +0.4 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 1.6 | NCT00898677: 4/388 (1.0%) on Sumatriptan Succinate |
| Diarrhoea (diarrhea) | 865 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.391 | 1.1 EB05 1.1 · IC025 +0.1 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.4 (1.3–1.6) | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00898677: 3/388 (0.8%) on Sumatriptan Succinate; 1/160 (0.6%) control |
| Anxiety | 844 | 2.5 2.3–2.6ROR 2.5 · calibrated p 0.803 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.1 (1.1–1.2) | Not in label — unassessed | serious PRR 2.9 | NCT00898677: 9/388 (2.3%) on Sumatriptan Succinate; 1/160 (0.6%) control |
| Arthralgia (joint pain) | 735 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.639 | 1.5 EB05 1.4 · IC025 +0.4 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Product quality issue | 705 | 4.4 4.1–4.7ROR 4.5 · calibrated p 0.300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.8 (1.7–2.0) | Reporting / coding artifact | serious PRR 2.1 · 80% consumer | not reported in cached trials |
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.
- Iiird nerve paresis — n=27, PRR 143.3
- Coronary artery dissection — n=51, PRR 53.6
- Reversible cerebral vasoconstriction syndrome — n=115, PRR 51.9
- Soft tissue injury — n=42, PRR 48.9
- Post-traumatic neck syndrome — n=45, PRR 48.8
- Cerebral vasoconstriction — n=25, PRR 29.2
- Sternal fracture — n=41, PRR 28.7
- Arteriospasm coronary — n=117, PRR 25.5
- Endometriosis — n=124, PRR 22.2 (also seen in trial arm)
- Brugada syndrome — n=23, PRR 19.2
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 Succinate?
In FDA FAERS, the most frequently co-reported reaction terms for Sumatriptan Succinate are headache, migraine, nausea, fatigue, dizziness, pain. 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 Succinate have an FDA boxed warning?
No. The FDA label retrieved for Sumatriptan Succinate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sumatriptan Succinate 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, fieldpatient.drug.openfda.generic_name.exact, 1,163 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 - ClinicalTrials.gov API v2 (query
SUMATRIPTAN, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.