Drug · FAERS side-effect profile with label screen
Rizatriptan Benzoate side effects: what 10,114 FDA adverse event reports show
Drug class
Serotonin (5-ht) 1b/1d receptor agonist (triptan)
FDA label, Indications wording
Who reports
10,114 reports · 59% serious · 194 with death outcome · 86% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Rizatriptan 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.
FDA label, Indications and Usage
What it is
Rizatriptan benzoate tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Rizatriptan benzoate 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:
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 1Labeled (related wording) 1Likely indication confounding 5Reporting / coding artifact 3Not in label — unassessed 30
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. 1,034 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 |
|---|---|---|---|---|---|---|
| Neovascularisation | 61 | 649.8 487.5–866.1ROR 653.7 · χ² 29,496 / p <1e-300 | 427.0 EB05 344.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=61 · 92% clinician | no trial data cached |
| Cervicogenic headache | 15 | 262.2 153.2–448.7ROR 262.6 · χ² 3,232 / p <1e-300 | 179.7 EB05 115.6 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Purpura senile | 12 | 231.5 127.5–420.5ROR 231.8 · χ² 2,271 / p <1e-300 | 156.7 EB05 95.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pineal gland cyst | 14 | 229.1 131.9–397.8ROR 229.4 · χ² 2,657 / p <1e-300 | 161.2 EB05 102.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Post-traumatic headache | 14 | 207.5 119.8–359.4ROR 207.8 · χ² 2,428 / p <1e-300 | 150.3 EB05 95.1 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | no trial data cached |
| Migraine without aura | 22 | 164.8 106.8–254.4ROR 165.2 · χ² 3,165 / p <1e-300 | 135.0 EB05 94.0 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications | serious n=20 | no trial data cached |
| Tarsal tunnel syndrome | 11 | 108.7 59.3–199.2ROR 108.8 · χ² 1,014 / p 7e-223 | 88.0 EB05 52.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Product used for unknown indication | 50 | 86.6 65.3–114.8ROR 87.0 · χ² 3,977 / p <1e-300 | 80.6 EB05 63.6 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=49 · ♀ 0% (drug 86%) | no trial data cached |
| Gastroenteritis radiation | 10 | 64.7 34.5–121.4ROR 64.8 · χ² 548 / p 2e-121 | 56.4 EB05 32.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Gallbladder polyp | 23 | 62.9 41.5–95.2ROR 63.0 · χ² 1,300 / p 7e-285 | 58.2 EB05 40.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Product ineffective for unapproved use | 33 | 50.1 35.5–70.7ROR 50.3 · χ² 1,503 / p <1e-300 | 47.7 EB05 35.5 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=33 | no trial data cached |
| Dust allergy | 21 | 46.1 29.9–71.1ROR 46.2 · χ² 863 / p 5e-190 | 43.5 EB05 30.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Medication overuse headache | 15 | 37.0 22.2–61.6ROR 37.1 · χ² 481 / p 5e-107 | 34.9 EB05 22.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=9 | no trial data cached |
| Sedation | 457 | 37.0 33.8–40.5ROR 38.7 · χ² 15,700 / p <1e-300 | 36.3 EB05 33.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 48.2 · ♀ 7% (drug 86%) | no trial data cached |
| Paradoxical drug reaction | 64 | 36.8 28.7–47.0ROR 37.0 · χ² 2,153 / p <1e-300 | 35.8 EB05 29.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=64 · 92% clinician | no trial data cached |
| Local anaesthetic systemic toxicity | 17 | 34.6 21.4–55.8ROR 34.6 · χ² 512 / p 1e-113 | 32.9 EB05 21.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Nasal discharge discolouration | 20 | 30.4 19.6–47.3ROR 30.5 · χ² 532 / p 4e-118 | 29.3 EB05 20.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Reflux oesophagitis | 11 | 30.1 16.6–54.5ROR 30.1 · χ² 277 / p 2e-62 | 28.3 EB05 16.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Allergy to animal | 15 | 30.0 18.1–50.0ROR 30.1 · χ² 387 / p 2e-86 | 28.7 EB05 18.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Resorption bone increased | 11 | 28.2 15.6–51.1ROR 28.2 · χ² 258 / p 2e-58 | 26.6 EB05 15.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Biliary dyskinesia | 23 | 28.2 18.7–42.5ROR 28.2 · χ² 568 / p 8e-126 | 27.2 EB05 19.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Nightmare | 455 | 27.5 25.1–30.1ROR 28.7 · χ² 11,453 / p <1e-300 | 27.1 EB05 25.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 44.5 · ♀ 6% (drug 86%) | no trial data cached |
| Complex regional pain syndrome | 19 | 26.8 17.1–42.1ROR 26.9 · χ² 441 / p 3e-98 | 25.9 EB05 17.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Postural orthostatic tachycardia syndrome | 16 | 25.6 15.6–41.9ROR 25.6 · χ² 350 / p 2e-78 | 24.6 EB05 16.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Pre-existing condition improved | 72 | 23.9 19.0–30.2ROR 24.1 · χ² 1,541 / p <1e-300 | 23.5 EB05 19.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial data cached |
| Migraine | 987 | 21.8 20.5–23.1ROR 24.0 · χ² 19,439 / p <1e-300 | 21.6 EB05 20.5 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 24.6 | no trial data cached |
| Cholecystitis chronic | 68 | 21.0 16.5–26.6ROR 21.1 · χ² 1,261 / p 1e-276 | 20.7 EB05 16.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 | no trial data cached |
| Vestibular disorder | 12 | 20.5 11.6–36.2ROR 20.5 · χ² 201 / p 5e-46 | 19.4 EB05 11.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Nephrolithiasis (kidney stones) | 426 | 19.5 17.7–21.4ROR 20.3 · χ² 7,398 / p <1e-300 | 19.3 EB05 17.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · ♀ 24% (drug 86%) | no trial data cached |
| Swollen tongue | 239 | 16.0 14.1–18.1ROR 16.3 · χ² 3,317 / p <1e-300 | 15.8 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 | no trial data cached |
| Migraine with aura | 20 | 15.4 9.9–23.9ROR 15.4 · χ² 253 / p 3e-57 | 14.7 EB05 9.7 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious n=16 | no trial data cached |
| Anuria | 63 | 15.2 11.9–19.5ROR 15.3 · χ² 816 / p 9e-180 | 15.0 EB05 12.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · 92% clinician | no trial data cached |
| Gallbladder injury | 14 | 15.1 8.9–25.5ROR 15.1 · χ² 169 / p 7e-39 | 14.0 EB05 8.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Oral mucosal erythema | 11 | 14.8 8.2–26.9ROR 14.9 · χ² 128 / p 7e-30 | 13.3 EB05 6.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Cataplexy | 10 | 14.6 7.8–27.2ROR 14.6 · χ² 113 / p 1e-26 | 12.8 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Oral pruritus | 16 | 14.6 8.9–23.8ROR 14.6 · χ² 188 / p 5e-43 | 13.6 EB05 8.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Thrombophlebitis superficial | 21 | 14.2 9.3–21.8ROR 14.3 · χ² 244 / p 3e-55 | 13.5 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Reversible cerebral vasoconstriction syndrome | 13 | 13.8 8.0–23.8ROR 13.8 · χ² 141 / p 8e-33 | 12.5 EB05 6.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Vertigo positional | 11 | 13.1 7.3–23.7ROR 13.1 · χ² 111 / p 3e-26 | 11.3 EB05 5.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Product administration interrupted | 45 | 12.2 9.1–16.4ROR 12.3 · χ² 450 / p 3e-100 | 11.9 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=45 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,507 | 2.4 2.3–2.5ROR 2.6 · χ² 1,277 / p 6e-280 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Nausea | 1,208 | 3.2 3.0–3.4ROR 3.5 · χ² 1,869 / p <1e-300 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Headache | 1,051 | 3.5 3.3–3.7ROR 3.8 · χ² 1,914 / p <1e-300 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.7 | no trial data cached |
| Migraine | 987 | 21.8 20.5–23.1ROR 24.0 · χ² 19,439 / p <1e-300 | 21.6 EB05 20.5 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 24.6 | no trial data cached |
| Off label use (used outside approved label) | 923 | 2.2 2.1–2.3ROR 2.3 · χ² 633 / p 5e-140 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · ♀ 60% (drug 86%) | no trial data cached |
| Fatigue (tiredness) | 659 | 1.8 1.6–1.9ROR 1.8 · χ² 223 / p 8e-51 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Pain | 608 | 2.1 1.9–2.2ROR 2.1 · χ² 335 / p 3e-75 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Product use in unapproved indication | 598 | 5.1 4.7–5.5ROR 5.3 · χ² 1,977 / p <1e-300 | 5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · ♀ 41% (drug 86%) | no trial data cached |
| Hyperhidrosis (excessive sweating) | 560 | 9.0 8.3–9.8ROR 9.5 · χ² 4,003 / p <1e-300 | 9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 24% (drug 86%) | no trial data cached |
| Vomiting | 466 | 2.1 1.9–2.3ROR 2.1 · χ² 259 / p 1e-58 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Sedation | 457 | 37.0 33.8–40.5ROR 38.7 · χ² 15,700 / p <1e-300 | 36.3 EB05 33.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 48.2 · ♀ 7% (drug 86%) | no trial data cached |
| Nightmare | 455 | 27.5 25.1–30.1ROR 28.7 · χ² 11,453 / p <1e-300 | 27.1 EB05 25.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 44.5 · ♀ 6% (drug 86%) | no trial data cached |
| Diarrhoea (diarrhea) | 446 | 1.4 1.3–1.6ROR 1.5 · χ² 61 / p 3e-15 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Dizziness | 429 | 1.8 1.6–2.0ROR 1.8 · χ² 151 / p 4e-35 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Nephrolithiasis (kidney stones) | 426 | 19.5 17.7–21.4ROR 20.3 · χ² 7,398 / p <1e-300 | 19.3 EB05 17.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · ♀ 24% (drug 86%) | 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.
- Neovascularisation — n=61, PRR 649.8
- Gallbladder polyp — n=23, PRR 62.9
- Dust allergy — n=21, PRR 46.1
- Sedation — n=457, PRR 37.0
- Paradoxical drug reaction — n=64, PRR 36.8
- Nasal discharge discolouration — n=20, PRR 30.4
- Biliary dyskinesia — n=23, PRR 28.2
- Nightmare — n=455, PRR 27.5
- Pre-existing condition improved — n=72, PRR 23.9
- Cholecystitis chronic — n=68, PRR 21.0
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 Benzoate?
In FDA FAERS, the most frequently co-reported reaction terms for Rizatriptan Benzoate are nausea, headache, migraine, fatigue, pain, hyperhidrosis. 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 Benzoate have an FDA boxed warning?
No. The FDA label retrieved for Rizatriptan Benzoate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rizatriptan Benzoate 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 075f47ee-88d1-102b-e063-6394a90acbf8, effective 20240325; matched on
openfda.generic_name.exact:"RIZATRIPTAN BENZOATE") - 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, 1,074 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.