Rizatriptan side effects: what 6,295 FDA adverse event reports show
Drug class
Serotonin (5-ht)1b/1d receptor agonist (triptan)
Who reports
6,295 reports · 57% serious · 142 with death outcome · 85% female
Used for
Ri zatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use • Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established.
What it is
Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N -dimethyl-5-(1 H -1,2,4-triazol-1-ylmethyl)-1 H -indole-3-ethanamine monobenzoate and its structural formula is:
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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. 434 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Migraine | 555 | 19.6 18.1–21.2ROR 21.4 · χ² 9,760 / p <1e-300 | 19.5 EB05 18.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 22.7 | no trial data cached |
| Serotonin syndrome | 98 | 17.1 14.1–20.9ROR 17.4 · χ² 1,468 / p <1e-300 | 17.0 EB05 14.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.0 | no trial data cached |
| Impaired gastric emptying | 42 | 11.0 8.1–14.9ROR 11.1 · χ² 371 / p 6e-83 | 10.6 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 85% consumer | no trial data cached |
| Impaired quality of life | 45 | 10.4 7.8–14.0ROR 10.5 · χ² 374 / p 1e-83 | 10.0 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Swollen tongue | 85 | 9.1 7.3–11.2ROR 9.2 · χ² 602 / p 3e-133 | 8.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Ankylosing spondylitis | 34 | 8.7 6.2–12.2ROR 8.8 · χ² 224 / p 6e-51 | 8.1 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Infusion site pain | 24 | 6.3 4.2–9.3ROR 6.3 · χ² 101 / p 5e-24 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=14 · 75% consumer | no trial data cached |
| Angioedema (deep swelling of face/throat) | 80 | 6.0 4.9–7.5ROR 6.1 · χ² 332 / p 2e-74 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 91% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 98 | 5.9 4.8–7.1ROR 5.9 · χ² 391 / p 3e-87 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 11.3 | no trial data cached |
| Dermatitis contact | 19 | 5.6 3.6–8.7ROR 5.6 · χ² 67 / p 1e-16 | 5.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Pharyngeal swelling | 16 | 5.6 3.4–9.1ROR 5.6 · χ² 55 / p 5e-14 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Dysphonia | 95 | 5.4 4.4–6.6ROR 5.5 · χ² 339 / p 6e-76 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Hereditary angioedema | 17 | 5.4 3.4–8.7ROR 5.4 · χ² 57 / p 3e-14 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Swelling face | 103 | 5.3 4.4–6.4ROR 5.4 · χ² 354 / p 3e-79 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Euphoric mood | 16 | 5.2 3.2–8.4ROR 5.2 · χ² 50 / p 9e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Brain injury | 15 | 5.0 3.0–8.3ROR 5.0 · χ² 44 / p 2e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Body height decreased | 16 | 4.9 3.0–8.1ROR 4.9 · χ² 46 / p 5e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Sleep apnoea syndrome | 26 | 4.5 3.1–6.7ROR 4.5 · χ² 68 / p 8e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Impaired work ability | 29 | 4.5 3.1–6.5ROR 4.5 · χ² 76 / p 2e-18 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · ♀ 65% (drug 85%) · 79% consumer | no trial data cached |
| Seasonal allergy | 19 | 4.5 2.9–7.0ROR 4.5 · χ² 48 / p 2e-12 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Middle insomnia | 25 | 4.5 3.0–6.6ROR 4.5 · χ² 64 / p 6e-16 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 · 87% consumer | no trial data cached |
| Skin infection | 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 PRR 5.0 | no trial data cached |
| Drug intolerance | 129 | 4.5 3.8–5.3ROR 4.5 · χ² 345 / p 3e-77 | 4.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Product taste abnormal | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 45 / p 1e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Gait inability | 44 | 4.4 3.3–5.9ROR 4.5 · χ² 114 / p 8e-27 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Hypokinesia | 19 | 4.4 2.8–6.8ROR 4.4 · χ² 46 / p 6e-12 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Bladder disorder | 13 | 4.4 2.5–7.5ROR 4.4 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Head discomfort | 23 | 4.4 2.9–6.5ROR 4.4 · χ² 56 / p 4e-14 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 74% consumer | no trial data cached |
| Ovarian cyst | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Insurance issue | 19 | 4.3 2.7–6.7ROR 4.3 · χ² 44 / p 1e-11 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Eyelid ptosis | 13 | 4.3 2.5–7.3ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Accident | 15 | 4.2 2.5–7.0ROR 4.2 · χ² 33 / p 4e-9 | 3.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Candida infection (yeast infection) | 21 | 4.2 2.7–6.4ROR 4.2 · χ² 48 / p 2e-12 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Neck pain | 70 | 4.2 3.3–5.3ROR 4.2 · χ² 166 / p 3e-38 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Vertigo (spinning dizziness) | 75 | 4.1 3.3–5.1ROR 4.1 · χ² 173 / p 8e-40 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Therapeutic response shortened | 39 | 4.1 3.0–5.6ROR 4.1 · χ² 88 / p 4e-21 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 | no trial data cached |
| Spinal pain | 14 | 4.0 2.4–6.7ROR 4.0 · χ² 28 / p 5e-8 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Sedation | 31 | 4.0 2.8–5.6ROR 4.0 · χ² 66 / p 3e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 45% (drug 85%) · 100% clinician | no trial data cached |
| Gastrointestinal pain | 13 | 4.0 2.3–6.8ROR 4.0 · χ² 26 / p 2e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Initial insomnia | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 7e-7 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 731 | 1.8 1.7–2.0ROR 2.0 · χ² 303 / p 3e-68 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Headache | 641 | 3.4 3.2–3.7ROR 3.7 · χ² 1,123 / p 2e-246 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.2 | no trial data cached |
| Nausea | 594 | 2.5 2.3–2.7ROR 2.7 · χ² 558 / p 1e-123 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Migraine | 555 | 19.6 18.1–21.2ROR 21.4 · χ² 9,760 / p <1e-300 | 19.5 EB05 18.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 22.7 | no trial data cached |
| Fatigue (tiredness) | 430 | 1.8 1.7–2.0ROR 1.9 · χ² 172 / p 2e-39 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Pain | 333 | 1.8 1.6–2.0ROR 1.8 · χ² 122 / p 1e-28 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Vomiting | 309 | 2.2 2.0–2.4ROR 2.3 · χ² 204 / p 1e-46 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Dizziness | 302 | 2.0 1.8–2.3ROR 2.1 · χ² 158 / p 1e-36 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Arthralgia (joint pain) | 257 | 2.1 1.8–2.3ROR 2.1 · χ² 143 / p 3e-33 | 2.1 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Product dose omission issue | 217 | 2.5 2.2–2.9ROR 2.6 · χ² 204 / p 2e-46 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 70% consumer | no trial data cached |
| Anxiety | 196 | 2.3 2.0–2.6ROR 2.3 · χ² 143 / p 3e-33 | 2.3 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Malaise (feeling unwell) | 190 | 1.4 1.3–1.7ROR 1.5 · χ² 26 / p 2e-7 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Product use in unapproved indication | 183 | 2.5 2.2–2.9ROR 2.5 · χ² 164 / p 6e-38 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Injection site pain (pain where injected) | 175 | 1.9 1.7–2.2ROR 1.9 · χ² 77 / p 7e-19 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 2.3 | no trial data cached |
| Pruritus (itching) | 159 | 1.4 1.2–1.6ROR 1.4 · χ² 18 / p 1e-5 | 1.4 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.5 | 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.
- Impaired gastric emptying — n=42, PRR 11.0
- Impaired quality of life — n=45, PRR 10.4
- Swollen tongue — n=85, PRR 9.1
- Ankylosing spondylitis — n=34, PRR 8.7
- Dysphonia — n=95, PRR 5.4
- Swelling face — n=103, PRR 5.3
- Sleep apnoea syndrome — n=26, PRR 4.5
- Impaired work ability — n=29, PRR 4.5
- Middle insomnia — n=25, PRR 4.5
- Gait inability — n=44, PRR 4.4
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 Rizatriptan?
In FDA FAERS, the most frequently co-reported reaction terms for Rizatriptan are headache, nausea, migraine, 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 Rizatriptan have an FDA boxed warning?
No. The FDA label retrieved for Rizatriptan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rizatriptan 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 27bc2cfc-fefb-4b50-a0dc-6268c69b4902, effective 20220701; matched on
openfda.generic_name.exact:"RIZATRIPTAN") - 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, 474 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.