Drug · FAERS side-effect profile with label screen
Zolmitriptan side effects: what 7,154 FDA adverse event reports show
Drug class
Serotonin-1b and Serotonin-1d Receptor Agonist
FDA label (Established Pharmacologic Class) · compare the class
Who reports
7,154 reports · 64% serious · 169 with death outcome · 86% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZOLMITRIPTAN NASAL SPRAY is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Only use ZOLMITRIPTAN NASAL SPRAY if a clear diagnosis of migraine has been established.
FDA label, Indications and Usage
What it is
ZOLMITRIPTAN NASAL SPRAY contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino) ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical 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 2Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 27
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 514 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 |
|---|---|---|---|---|---|---|
| Migraine | 1,020 | 31.8 30.1–33.7ROR 37.0 · χ² 30,247 / p <1e-300 | 31.5 EB05 29.9 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 26.1 | no trial data cached |
| Swollen tongue | 212 | 20.0 17.5–22.8ROR 20.6 · χ² 3,788 / p <1e-300 | 19.8 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 216 | 14.4 12.6–16.4ROR 14.8 · χ² 2,674 / p <1e-300 | 14.3 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | no trial data cached |
| Temperature intolerance | 44 | 12.7 9.4–17.0ROR 12.8 · χ² 460 / p 2e-102 | 12.3 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=37 | no trial data cached |
| Therapy partial responder | 60 | 11.7 9.1–15.1ROR 11.8 · χ² 576 / p 2e-127 | 11.4 EB05 9.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 12.3 · ♀ 50% (drug 86%) | no trial data cached |
| Dysphonia | 227 | 11.4 10.1–13.0ROR 11.8 · χ² 2,147 / p <1e-300 | 11.3 EB05 10.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Intentional drug misuse | 80 | 11.1 8.9–13.8ROR 11.2 · χ² 722 / p 2e-159 | 10.9 EB05 8.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · 82% consumer | no trial data cached |
| Drug intolerance | 352 | 10.8 9.7–11.9ROR 11.3 · χ² 3,107 / p <1e-300 | 10.7 EB05 9.8 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.5 | no trial data cached |
| Swelling face | 219 | 9.9 8.7–11.3ROR 10.2 · χ² 1,743 / p <1e-300 | 9.8 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Drug ineffective for unapproved indication | 178 | 9.4 8.1–10.9ROR 9.6 · χ² 1,324 / p 3e-290 | 9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 17.7 | no trial data cached |
| Sputum discoloured | 25 | 7.8 5.2–11.5ROR 7.8 · χ² 140 / p 1e-32 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Muscle tightness | 40 | 7.3 5.3–9.9ROR 7.3 · χ² 209 / p 9e-48 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Serotonin syndrome | 44 | 6.8 5.0–9.1ROR 6.8 · χ² 210 / p 8e-48 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Tenderness | 23 | 6.5 4.3–9.7ROR 6.5 · χ² 101 / p 5e-24 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Throat tightness | 57 | 6.2 4.8–8.0ROR 6.2 · χ² 243 / p 5e-55 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Hypomagnesaemia | 29 | 6.1 4.3–8.8ROR 6.2 · χ² 119 / p 4e-28 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 100% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 23 | 6.1 4.0–9.2ROR 6.1 · χ² 93 / p 3e-22 | 5.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 | no trial data cached |
| Fibromyalgia | 48 | 5.8 4.4–7.7ROR 5.8 · χ² 186 / p 1e-42 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Sleep apnoea syndrome | 37 | 5.7 4.1–7.8ROR 5.7 · χ² 138 / p 4e-32 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Dyspnoea exertional | 70 | 5.5 4.3–6.9ROR 5.5 · χ² 251 / p 6e-57 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Ear discomfort | 19 | 5.4 3.5–8.5ROR 5.5 · χ² 65 / p 5e-16 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Disturbance in attention | 97 | 5.3 4.3–6.4ROR 5.3 · χ² 331 / p 3e-74 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Sneezing | 40 | 5.2 3.9–7.2ROR 5.3 · χ² 133 / p 4e-31 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Tuberculosis | 23 | 5.2 3.5–7.9ROR 5.3 · χ² 75 / p 3e-18 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Ear pain | 34 | 5.1 3.7–7.2ROR 5.2 · χ² 109 / p 9e-26 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | no trial data cached |
| Oral herpes | 33 | 5.0 3.5–7.0ROR 5.0 · χ² 101 / p 5e-24 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Drug dose omission | 284 | 5.0 4.4–5.6ROR 5.1 · χ² 902 / p 1e-198 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 95% consumer | no trial data cached |
| Stress | 116 | 4.7 4.0–5.7ROR 4.8 · χ² 338 / p 7e-76 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Photophobia (light sensitivity) | 30 | 4.7 3.3–6.7ROR 4.7 · χ² 84 / p 2e-20 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Brain injury | 16 | 4.7 2.9–7.6ROR 4.7 · χ² 43 / p 3e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Joint range of motion decreased | 21 | 4.6 3.0–7.1ROR 4.6 · χ² 56 / p 4e-14 | 4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Mouth ulceration | 33 | 4.6 3.3–6.5ROR 4.6 · χ² 89 / p 2e-21 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 100% clinician | no trial data cached |
| Seasonal allergy | 22 | 4.6 3.0–6.9ROR 4.6 · χ² 58 / p 1e-14 | 4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Bipolar disorder | 17 | 4.6 2.8–7.3ROR 4.6 · χ² 44 / p 2e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Vitamin d deficiency | 15 | 4.5 2.7–7.5ROR 4.5 · χ² 38 / p 4e-10 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Paralysis | 22 | 4.5 3.0–6.8ROR 4.5 · χ² 56 / p 3e-14 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 81% consumer | no trial data cached |
| Nephrolithiasis (kidney stones) | 70 | 4.5 3.6–5.7ROR 4.5 · χ² 187 / p 9e-43 | 4.4 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Ligament sprain | 15 | 4.5 2.7–7.4ROR 4.5 · χ² 37 / p 6e-10 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Headache | 935 | 4.4 4.1–4.7ROR 4.9 · χ² 2,508 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.6 | no trial data cached |
| Vertigo (spinning dizziness) | 89 | 4.3 3.5–5.3ROR 4.3 · χ² 221 / p 3e-50 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | 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 |
|---|---|---|---|---|---|---|
| Migraine | 1,020 | 31.8 30.1–33.7ROR 37.0 · χ² 30,247 / p <1e-300 | 31.5 EB05 29.9 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 26.1 | no trial data cached |
| Headache | 935 | 4.4 4.1–4.7ROR 4.9 · χ² 2,508 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.6 | no trial data cached |
| Drug ineffective (drug did not work) | 747 | 1.7 1.6–1.8ROR 1.7 · χ² 210 / p 7e-48 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Nausea | 554 | 2.1 1.9–2.2ROR 2.1 · χ² 312 / p 4e-70 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Off label use (used outside approved label) | 537 | 1.8 1.7–2.0ROR 1.9 · χ² 204 / p 2e-46 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Fatigue (tiredness) | 482 | 1.8 1.7–2.0ROR 1.9 · χ² 184 / p 4e-42 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Pain | 431 | 2.1 1.9–2.3ROR 2.1 · χ² 239 / p 4e-54 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Drug intolerance | 352 | 10.8 9.7–11.9ROR 11.3 · χ² 3,107 / p <1e-300 | 10.7 EB05 9.8 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 14.5 | no trial data cached |
| Vomiting | 342 | 2.1 1.9–2.4ROR 2.2 · χ² 211 / p 5e-48 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Dizziness | 332 | 2.0 1.8–2.2ROR 2.0 · χ² 158 / p 2e-36 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Malaise (feeling unwell) | 298 | 2.0 1.8–2.2ROR 2.0 · χ² 148 / p 2e-34 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 290 | 1.5 1.3–1.7ROR 1.5 · χ² 50 / p 9e-13 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Drug dose omission | 284 | 5.0 4.4–5.6ROR 5.1 · χ² 902 / p 1e-198 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 95% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 270 | 4.3 3.8–4.8ROR 4.4 · χ² 679 / p 6e-150 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Insomnia (trouble sleeping) | 256 | 2.8 2.5–3.2ROR 2.9 · χ² 301 / p 9e-68 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | 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=212, PRR 20.0
- Temperature intolerance — n=44, PRR 12.7
- Dysphonia — n=227, PRR 11.4
- Swelling face — n=219, PRR 9.9
- Sputum discoloured — n=25, PRR 7.8
- Muscle tightness — n=40, PRR 7.3
- Tenderness — n=23, PRR 6.5
- Hypomagnesaemia — n=29, PRR 6.1
- Fibromyalgia — n=48, PRR 5.8
- Sleep apnoea syndrome — n=37, PRR 5.7
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 Zolmitriptan?
In FDA FAERS, the most frequently co-reported reaction terms for Zolmitriptan are migraine, headache, nausea, fatigue, pain, vomiting. 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 Zolmitriptan have an FDA boxed warning?
No. The FDA label retrieved for Zolmitriptan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Zolmitriptan 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 05a40502-149d-41bd-966e-771e937a955b, effective 20190430; matched on
openfda.generic_name.exact:"ZOLMITRIPTAN") - 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, 554 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.