Drug · FAERS side-effect profile with label screen
Rimegepant side effects: what 12,592 FDA adverse event reports show
Drug class
Calcitonin gene-related peptide receptor antagonist
FDA label, Indications wording of the closest related product
Label matched
Rimegepant Sulfate (Nurtec Odt)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
12,592 reports · 19% serious · 109 with death outcome · 86% female
openFDA FAERS counts, all years, deduplication not applied
Used for
NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: • acute treatment of migraine with or without aura in adults ( 1.1 ) • preventive treatment of episodic migraine in adults ( 1.2 ) 1.1 Acute Treatment of Migraine NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults .
FDA label, Indications and Usage
What it is
NURTEC ODT contains rimegepant sulfate, a calcitonin gene-related peptide receptor antagonist. Rimegepant sulfate is described chemically as (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-t.
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
Likely indication confounding 3Reporting / coding artifact 15Not in label — unassessed 22
What the badges mean
- 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. 955 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 |
|---|---|---|---|---|---|---|
| Postnatal growth restriction | 45 | 1,070.5 735.6–1,557.8ROR 1,074.3 · χ² 28,458 / p <1e-300 | 507.7 EB05 394.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 19% (drug 86%) · 100% clinician | no trial data cached |
| Therapeutic product effect variable | 178 | 81.4 70.1–94.5ROR 82.5 · χ² 13,391 / p <1e-300 | 77.0 EB05 67.9 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Medication overuse headache | 35 | 71.0 50.6–99.6ROR 71.2 · χ² 2,249 / p <1e-300 | 65.8 EB05 49.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Therapeutic product effect delayed | 131 | 49.8 41.9–59.2ROR 50.3 · χ² 6,032 / p <1e-300 | 48.0 EB05 41.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=6 · 88% consumer | no trial data cached |
| Gestational hypertension | 21 | 27.8 18.1–42.7ROR 27.8 · χ² 507 / p 1e-112 | 26.7 EB05 18.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Product after taste | 13 | 23.4 13.5–40.4ROR 23.4 · χ² 253 / p 3e-57 | 22.3 EB05 13.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Aura | 20 | 18.1 11.6–28.1ROR 18.1 · χ² 302 / p 5e-68 | 17.5 EB05 11.7 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious n=6 · 75% consumer | no trial data cached |
| Therapeutic product effect incomplete | 647 | 15.4 14.2–16.6ROR 16.1 · χ² 8,621 / p <1e-300 | 15.2 EB05 14.3 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 91% consumer | no trial data cached |
| Migraine | 858 | 15.2 14.2–16.2ROR 16.2 · χ² 11,299 / p <1e-300 | 15.0 EB05 14.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 27.4 · 81% consumer | no trial data cached |
| Product administration interrupted | 69 | 15.1 11.9–19.1ROR 15.2 · χ² 887 / p 4e-195 | 14.9 EB05 12.1 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=65 | no trial data cached |
| Reaction to excipient | 20 | 14.6 9.4–22.6ROR 14.6 · χ² 237 / p 8e-54 | 13.8 EB05 9.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Mast cell activation syndrome | 11 | 13.9 7.7–25.2ROR 13.9 · χ² 118 / p 7e-28 | 12.2 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Therapeutic response delayed | 21 | 12.6 8.2–19.4ROR 12.6 · χ² 212 / p 3e-48 | 11.8 EB05 7.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Migraine with aura | 16 | 9.9 6.0–16.1ROR 9.9 · χ² 118 / p 8e-28 | 8.5 EB05 5.3 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | – | no trial data cached |
| Drug effect less than expected | 81 | 9.6 7.7–11.9ROR 9.7 · χ² 613 / p 1e-135 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=10 · 74% consumer | no trial data cached |
| Therapeutic product effect decreased | 241 | 9.1 8.0–10.3ROR 9.2 · χ² 1,719 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 82% consumer | no trial data cached |
| Tension headache | 23 | 9.0 5.9–13.5ROR 9.0 · χ² 154 / p 1e-35 | 8.0 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Live birth | 44 | 8.8 6.6–11.9ROR 8.9 · χ² 296 / p 1e-66 | 8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 | no trial data cached |
| Product packaging difficult to open | 13 | 8.8 5.1–15.2ROR 8.8 · χ² 82 / p 8e-20 | 7.2 EB05 4.3 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Allergic reaction to excipient | 10 | 8.5 4.6–15.8ROR 8.5 · χ² 58 / p 1e-14 | 6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Electric shock sensation | 12 | 7.5 4.2–13.1ROR 7.5 · χ² 61 / p 4e-15 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Pre-eclampsia | 21 | 7.4 4.8–11.4ROR 7.4 · χ² 110 / p 6e-26 | 6.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Hangover | 15 | 7.1 4.3–11.8ROR 7.1 · χ² 72 / p 1e-17 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Pharyngeal swelling | 37 | 6.5 4.7–8.9ROR 6.5 · χ² 165 / p 6e-38 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=17 · 80% consumer | no trial data cached |
| Therapeutic response shortened | 117 | 6.1 5.1–7.4ROR 6.2 · χ² 497 / p 2e-110 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 71% consumer | no trial data cached |
| Product solubility abnormal | 18 | 6.0 3.8–9.6ROR 6.0 · χ² 70 / p 3e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Brain fog | 52 | 5.9 4.5–7.8ROR 6.0 · χ² 209 / p 1e-47 | 5.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 · 71% consumer | no trial data cached |
| Incorrect drug administration rate | 15 | 5.9 3.6–9.8ROR 5.9 · χ² 56 / p 3e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Infusion site pruritus | 11 | 5.9 3.3–10.6ROR 5.9 · χ² 40 / p 1e-10 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Vomiting projectile | 10 | 5.8 3.1–10.9ROR 5.8 · χ² 35 / p 1e-9 | 4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Product use complaint | 53 | 5.7 4.4–7.5ROR 5.7 · χ² 201 / p 8e-46 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=5 · 92% consumer | no trial data cached |
| Emergency care | 10 | 5.6 3.0–10.4ROR 5.6 · χ² 33 / p 4e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Impaired gastric emptying | 40 | 5.2 3.8–7.1ROR 5.2 · χ² 132 / p 6e-31 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 | no trial data cached |
| Head discomfort | 55 | 5.2 4.0–6.8ROR 5.2 · χ² 182 / p 7e-42 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 95% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 4,050 | 5.1 5.0–5.3ROR 7.1 · χ² 14,329 / p <1e-300 | 5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 85% consumer | no trial data cached |
| Product taste abnormal | 41 | 5.1 3.7–6.9ROR 5.1 · χ² 130 / p 2e-30 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=4 · 80% consumer | no trial data cached |
| Gestational diabetes | 14 | 5.0 2.9–8.4ROR 5.0 · χ² 40 / p 1e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Tongue discomfort | 12 | 4.8 2.7–8.4ROR 4.8 · χ² 32 / p 8e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Feeling drunk | 21 | 4.7 3.1–7.2ROR 4.7 · χ² 57 / p 2e-14 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=6 · 90% consumer | no trial data cached |
| Paraesthesia oral | 39 | 4.5 3.3–6.2ROR 4.5 · χ² 103 / p 1e-24 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 79% consumer | 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) | 4,050 | 5.1 5.0–5.3ROR 7.1 · χ² 14,329 / p <1e-300 | 5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 85% consumer | no trial data cached |
| Nausea | 1,176 | 2.5 2.4–2.6ROR 2.6 · χ² 1,079 / p 5e-237 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 81% consumer | no trial data cached |
| Migraine | 858 | 15.2 14.2–16.2ROR 16.2 · χ² 11,299 / p <1e-300 | 15.0 EB05 14.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 27.4 · 81% consumer | no trial data cached |
| Headache | 767 | 2.0 1.9–2.2ROR 2.1 · χ² 418 / p 4e-93 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 3.6 · 77% consumer | no trial data cached |
| Therapeutic product effect incomplete | 647 | 15.4 14.2–16.6ROR 16.1 · χ² 8,621 / p <1e-300 | 15.2 EB05 14.3 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 91% consumer | no trial data cached |
| Off label use (used outside approved label) | 507 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.267 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | no trial data cached |
| Dizziness | 453 | 1.5 1.4–1.7ROR 1.5 · χ² 81 / p 1e-19 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.5 · 77% consumer | no trial data cached |
| Fatigue (tiredness) | 446 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.170 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.8 · 79% consumer | no trial data cached |
| Vomiting | 385 | 1.4 1.2–1.5ROR 1.4 · χ² 38 / p 3e-10 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 2.1 · 77% consumer | no trial data cached |
| Feeling abnormal | 325 | 2.3 2.0–2.5ROR 2.3 · χ² 227 / p 1e-51 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 88% consumer | no trial data cached |
| Product dose omission issue | 293 | 1.7 1.5–1.9ROR 1.7 · χ² 87 / p 4e-21 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 7.0 · 77% consumer | no trial data cached |
| Pain | 290 | 0.8 0.7–0.9ROR 0.8 · χ² 17 / p 1e-5 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.8 · 73% consumer | no trial data cached |
| Somnolence (drowsiness) | 284 | 2.4 2.1–2.6ROR 2.4 · χ² 221 / p 2e-50 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 83% consumer | no trial data cached |
| Rash | 280 | 1.1 1.0–1.2ROR 1.1 · χ² 1 / p 0.117 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Pruritus (itching) | 256 | 1.1 1.0–1.3ROR 1.1 · χ² 4 / p 0.028 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.0 | 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.
- Postnatal growth restriction — n=45, PRR 1,070.5
- Medication overuse headache — n=35, PRR 71.0
- Gestational hypertension — n=21, PRR 27.8
- Reaction to excipient — n=20, PRR 14.6
- Tension headache — n=23, PRR 9.0
- Live birth — n=44, PRR 8.8
- Pre-eclampsia — n=21, PRR 7.4
- Pharyngeal swelling — n=37, PRR 6.5
- Brain fog — n=52, PRR 5.9
- Impaired gastric emptying — n=40, PRR 5.2
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 Rimegepant?
In FDA FAERS, the most frequently co-reported reaction terms for Rimegepant are nausea, migraine, headache, dizziness, fatigue, 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 Rimegepant have an FDA boxed warning?
No. The FDA label retrieved for Rimegepant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rimegepant 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 9ef08e09-1098-35cc-e053-2a95a90a3e1d, effective 20260604; matched on
openfda.generic_name.exact:"RIMEGEPANT SULFATE") - 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, 995 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.