Drug · FAERS side-effect profile with label screen
Sumatriptan side effects: what 37,870 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
37,870 reports · 50% serious · 899 with death outcome · 85% 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 3Labeled (related wording) 2Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 28
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.
- 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). 1,135 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 |
|---|---|---|---|---|---|---|
| Medication overuse headache | 131 | 100.2 83.2–120.7ROR 100.5 · calibrated p 1e-7 ✓ | 83.8 EB05 72.4 · IC025 +5.7 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.6–2.6) | Labeled adverse reaction exact term | serious n=99 | not reported in cached trials |
| Iiird nerve paresis | 25 | 86.8 56.9–132.4ROR 86.9 · calibrated p 9e-7 ✓ | 71.1 EB05 50.7 · IC025 +4.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.9 (1.1–3.2) | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Migraine without aura | 23 | 46.1 30.1–70.6ROR 46.1 · calibrated p 5e-5 ✓ | 41.2 EB05 28.9 · IC025 +3.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.5 (0.9–2.6) | Likely indication confounding term in indications | serious n=20 | not reported in cached trials |
| Coronary artery dissection | 54 | 37.7 28.7–49.7ROR 37.8 · calibrated p 1e-4 ✓ | 35.0 EB05 27.8 · IC025 +4.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.1 (1.4–3.1) | Not in label — unassessed | serious n=54 · 100% clinician | not reported in cached trials |
| Reversible cerebral vasoconstriction syndrome | 103 | 30.6 25.1–37.3ROR 30.7 · calibrated p 3e-4 ✓ | 28.9 EB05 24.5 · IC025 +4.4 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.8 (1.4–2.3) | Not in label — unassessed | serious n=103 · 100% clinician | not reported in cached trials |
| Cluster headache | 70 | 30.0 23.6–38.1ROR 30.0 · calibrated p 3e-4 ✓ | 28.3 EB05 23.1 · IC025 +4.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.6–3.1) | Likely indication confounding term in indications | serious n=36 · ♀ 45% (drug 85%) | not reported in cached trials |
| Post-traumatic neck syndrome | 32 | 22.6 15.9–32.2ROR 22.6 · calibrated p 0.002 ✓ | 21.5 EB05 15.9 · IC025 +3.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.4 (0.9–2.2) | Not in label — unassessed | serious n=31 · 100% clinician | not reported in cached trials |
| Arteriospasm coronary | 142 | 20.6 17.5–24.4ROR 20.7 · calibrated p 0.002 ✓ | 19.9 EB05 17.3 · IC025 +3.9 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.4 (1.9–3.1) | Not in label — unassessed | serious n=141 · ♀ 64% (drug 85%) | not reported in cached trials |
| Soft tissue injury | 25 | 18.9 12.7–28.1ROR 18.9 · calibrated p 0.004 ✓ | 18.0 EB05 12.7 · IC025 +3.1 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.2 (0.7–2.0) | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Myofascial pain syndrome | 23 | 18.4 12.1–27.9ROR 18.4 · calibrated p 0.004 ✓ | 17.5 EB05 12.1 · 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=21 | not reported in cached trials |
| Vasospasm | 29 | 18.1 12.5–26.2ROR 18.1 · calibrated p 0.004 ✓ | 17.3 EB05 12.5 · IC025 +3.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.4 (1.4–4.1) | Labeled adverse reaction exact term | serious n=28 · 100% clinician | not reported in cached trials |
| Migraine | 2,806 | 16.8 16.2–17.5ROR 18.1 · calibrated p 0.003 ✓ | 16.4 EB05 15.9 · IC025 +4.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.9–2.1) | Likely indication confounding term in indications; also in warnings | serious PRR 19.5 | not reported in cached trials |
| Superior sagittal sinus thrombosis | 22 | 15.5 10.1–23.6ROR 15.5 · calibrated p 0.009 ✓ | 14.6 EB05 9.8 · 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=22 | not reported in cached trials |
| Drug specific antibody | 36 | 15.0 10.8–20.8ROR 15.0 · calibrated p 0.009 ✓ | 14.3 EB05 10.7 · IC025 +3.1 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 0.8 (0.6–1.3) | Lab value / disease marker | serious n=36 · 100% consumer | not reported in cached trials |
| Migraine with aura | 66 | 13.8 10.8–17.6ROR 13.8 · calibrated p 0.011 ✓ | 13.3 EB05 10.8 · IC025 +3.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.9 (2.0–4.2) | Likely indication confounding term in indications | serious n=44 | not reported in cached trials |
| Intracranial venous sinus thrombosis | 26 | 13.6 9.2–20.0ROR 13.6 · calibrated p 0.013 ✓ | 12.8 EB05 8.8 · 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=26 | not reported in cached trials |
| Device deployment issue | 280 | 13.2 11.7–14.9ROR 13.3 · calibrated p 0.012 ✓ | 12.9 EB05 11.7 · IC025 +3.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.7–2.4) | Reporting / coding artifact | – | not reported in cached trials |
| Sternal fracture | 28 | 12.8 8.8–18.7ROR 12.8 · calibrated p 0.016 ✓ | 12.1 EB05 8.4 · IC025 +2.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.4 (0.8–2.2) | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Pharmaceutical product complaint | 593 | 12.7 11.7–13.8ROR 12.9 · calibrated p 0.013 ✓ | 12.4 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 98.8 (55.8–175.0) | Not in label — unassessed | serious PRR 2.3 · 91% consumer | not reported in cached trials |
| Pre-existing condition improved | 137 | 12.3 10.4–14.5ROR 12.3 · calibrated p 0.016 ✓ | 11.9 EB05 10.3 · IC025 +3.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.6 (2.0–3.4) | Not in label — unassessed | serious n=65 | not reported in cached trials |
| Biliary dyskinesia | 36 | 11.8 8.5–16.5ROR 11.9 · calibrated p 0.021 ✓ | 11.2 EB05 8.2 · 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=37 | not reported in cached trials |
| Pituitary tumour benign | 32 | 11.0 7.7–15.6ROR 11.0 · calibrated p 0.027 ✓ | 10.2 EB05 7.3 · IC025 +2.6 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 |
| Endometriosis | 90 | 10.6 8.6–13.1ROR 10.6 · calibrated p 0.027 ✓ | 10.2 EB05 8.5 · IC025 +3.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.5 (1.1–1.9) | Not in label — unassessed | serious n=89 | NCT00898677: 1/164 (0.6%) on Sumatriptan (serious AE) |
| Therapeutic response delayed | 52 | 10.5 8.0–13.8ROR 10.5 · calibrated p 0.030 ✓ | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 6.1 (3.5–10.6) | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Binge eating | 20 | 10.5 6.7–16.3ROR 10.5 · calibrated p 0.035 ✓ | 9.3 EB05 6.0 · IC025 +2.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.2–4.2) | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Colitis ischaemic | 118 | 9.9 8.2–11.8ROR 9.9 · calibrated p 0.035 ✓ | 9.6 EB05 8.2 · IC025 +2.9 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.9 (1.5–2.4) | Not in label — unassessed | serious n=118 | not reported in cached trials |
| Abortion missed | 22 | 9.7 6.4–14.8ROR 9.7 · calibrated p 0.044 ✓ | 8.6 EB05 5.8 · IC025 +2.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.1 (1.2–3.8) | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Clonus | 47 | 9.6 7.2–12.9ROR 9.6 · calibrated p 0.040 ✓ | 9.0 EB05 7.0 · IC025 +2.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.8 (1.2–2.7) | Not in label — unassessed | serious n=46 · 100% clinician | not reported in cached trials |
| Application site paraesthesia | 22 | 9.4 6.2–14.4ROR 9.4 · calibrated p 0.048 ✓ | 8.3 EB05 5.6 · IC025 +2.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 3.1 (1.6–6.1) | Labeled (related wording) related wording | – | not reported in cached trials |
| Cholecystitis chronic | 113 | 9.4 7.8–11.3ROR 9.4 · calibrated p 0.042 ✓ | 9.0 EB05 7.7 · IC025 +2.8 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 10.8 (6.8–17.1) | Not in label — unassessed | serious PRR 10.6 | not reported in cached trials |
| Microcephaly | 21 | 9.3 6.0–14.3ROR 9.3 · calibrated p 0.051 | 8.2 EB05 5.4 · IC025 +2.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.8 (1.0–3.1) | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Renal infarct | 24 | 9.3 6.2–13.9ROR 9.3 · calibrated p 0.050 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.8 (1.0–3.1) | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Tension headache | 67 | 8.8 6.9–11.1ROR 8.8 · calibrated p 0.053 | 8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.6–3.1) | Labeled (related wording) related wording | serious n=45 | not reported in cached trials |
| Gallbladder injury | 30 | 8.7 6.1–12.4ROR 8.7 · calibrated p 0.059 | 7.9 EB05 5.7 · IC025 +2.3 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 |
| Cerebral venous thrombosis | 28 | 8.6 5.9–12.5ROR 8.6 · calibrated p 0.061 | 7.8 EB05 5.5 · IC025 +2.3 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (1.3–3.8) | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Hyperacusis | 55 | 8.3 6.3–10.8ROR 8.3 · calibrated p 0.064 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 3.9 (2.5–6.2) | Not in label — unassessed | serious n=35 | not reported in cached trials |
| Secondary adrenocortical insufficiency | 22 | 8.2 5.4–12.6ROR 8.2 · calibrated p 0.072 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.1–3.6) | Not in label — unassessed | serious n=22 · 100% clinician | not reported in cached trials |
| Angle closure glaucoma | 35 | 7.7 5.5–10.7ROR 7.7 · calibrated p 0.084 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.6 (1.6–4.3) | Not in label — unassessed | serious n=34 · 100% clinician | not reported in cached trials |
| Serotonin syndrome | 261 | 7.6 6.8–8.6ROR 7.7 · calibrated p 0.076 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.9 (1.6–2.2) | Labeled adverse reaction exact term | serious PRR 8.8 | not reported in cached trials |
| Nipple pain | 27 | 7.4 5.1–10.9ROR 7.4 · calibrated p 0.094 | 6.7 EB05 4.8 · IC025 +2.1 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=23 | 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 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) | 5,500 | 2.3 2.3–2.4ROR 2.5 · calibrated p 0.796 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 3.1 (2.9–3.2) | Reporting / coding artifact | serious PRR 2.1 · 73% consumer | not reported in cached trials |
| Headache | 3,179 | 2.8 2.7–2.9ROR 3.0 · calibrated p 0.631 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.1 (2.0–2.2) | Likely indication confounding term in indications; also in warnings | serious PRR 3.6 | NCT00898677: 11/388 (2.8%) on Sumatriptan; 2/160 (1.2%) control |
| Nausea | 2,872 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.999 | 2.0 EB05 2.0 · IC025 +0.9 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.5 (2.3–2.6) | Labeled adverse reaction exact term | serious PRR 2.4 | NCT00898677: 35/388 (9.0%) on Sumatriptan; 4/160 (2.5%) control |
| Migraine | 2,806 | 16.8 16.2–17.5ROR 18.1 · calibrated p 0.003 ✓ | 16.4 EB05 15.9 · IC025 +4.0 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.0 (1.9–2.1) | Likely indication confounding term in indications; also in warnings | serious PRR 19.5 | not reported in cached trials |
| Fatigue (tiredness) | 2,153 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.686 | 1.5 EB05 1.5 · IC025 +0.5 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (2.1–2.3) | Not in label — unassessed | serious PRR 1.9 | NCT00898677: 32/388 (8.2%) on Sumatriptan; 6/160 (3.8%) control |
| Pain | 2,001 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.858 | 1.8 EB05 1.7 · IC025 +0.8 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.5 (2.3–2.7) | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00898677: 20/388 (5.2%) on Sumatriptan; 2/160 (1.2%) control |
| Dizziness | 1,719 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.921 | 1.9 EB05 1.8 · IC025 +0.9 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (2.1–2.4) | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00898677: 35/388 (9.0%) on Sumatriptan; 6/160 (3.8%) control |
| Vomiting | 1,642 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.936 | 1.9 EB05 1.9 · IC025 +0.9 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.5 (2.4–2.7) | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00898677: 10/388 (2.6%) on Sumatriptan; 8/160 (5.0%) control |
| Dyspnoea (shortness of breath) | 1,367 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.543 | 1.3 EB05 1.3 · IC025 +0.3 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (2.1–2.4) | Not in label — unassessed | serious PRR 1.6 | NCT00898677: 4/388 (1.0%) on Sumatriptan |
| Off label use (used outside approved label) | 1,302 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.198 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 1.5 (1.4–1.6) | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Anxiety | 1,285 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.791 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.5 (2.3–2.7) | Not in label — unassessed | serious PRR 3.3 | NCT00898677: 9/388 (2.3%) on Sumatriptan; 1/160 (0.6%) control |
| Diarrhoea (diarrhea) | 1,216 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.338 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.8 (2.6–3.1) | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00898677: 3/388 (0.8%) on Sumatriptan; 1/160 (0.6%) control |
| Arthralgia (joint pain) | 1,079 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.612 | 1.4 EB05 1.4 · IC025 +0.4 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (2.0–2.4) | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Malaise (feeling unwell) | 1,071 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.548 | 1.3 EB05 1.3 · IC025 +0.3 vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.2 (2.0–2.4) | Not in label — unassessed | serious PRR 1.5 | not reported in cached trials |
| Depression | 1,054 | 2.6 2.4–2.7ROR 2.6 · calibrated p 0.770 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Serotonin-1b and Serotonin-1d Receptor Agonists: PRR 2.3 (2.1–2.5) | Labeled (related wording) related wording | serious PRR 3.2 | NCT00898677: 3/388 (0.8%) on Sumatriptan |
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=25, PRR 86.8
- Coronary artery dissection — n=54, PRR 37.7
- Reversible cerebral vasoconstriction syndrome — n=103, PRR 30.6
- Post-traumatic neck syndrome — n=32, PRR 22.6
- Arteriospasm coronary — n=142, PRR 20.6
- Soft tissue injury — n=25, PRR 18.9
- Myofascial pain syndrome — n=23, PRR 18.4
- Superior sagittal sinus thrombosis — n=22, PRR 15.5
- Intracranial venous sinus thrombosis — n=26, PRR 13.6
- Sternal fracture — n=28, PRR 12.8
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?
In FDA FAERS, the most frequently co-reported reaction terms for Sumatriptan are headache, nausea, migraine, fatigue, pain, dizziness. 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 have an FDA boxed warning?
No. The FDA label retrieved for Sumatriptan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sumatriptan 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, 1,175 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.