Zavegepant side effects: what 856 FDA adverse event reports show

Zavegepant · Zavzpret · 14 reaction terms · 531 drug–reaction co-reports · data 2026-09-14

Drug class

Calcitonin gene-related peptide receptor antagonist

FDA label, Indications wording

Brand names

Zavzpret

openFDA label

Who reports

856 reports · 9% serious · 0 with death outcome · 89% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ( 1 )

FDA label, Indications and Usage

What it is

ZAVZPRET (zavegepant) nasal spray contains zavegepant hydrochloride, a calcitonin gene-related peptide receptor antagonist. Zavegepant hydrochloride is described chemically as (R)-N-(3-(7-meth.

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 12 strongest signals

Labeled adverse reaction 2Likely indication confounding 1Reporting / coding artifact 4Not in label — unassessed 5

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.
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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dysgeusia (altered taste)	248	81.5 73.4–90.6ROR 114.3 · χ² 19,647 / p <1e-300	80.8 EB05 72.7 · IC025 +5.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.6	no trial data cached
Taste disorder	36	44.0 32.0–60.6ROR 45.9 · χ² 1,470 / p <1e-300	43.0 EB05 32.5 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.6	no trial data cached
Throat irritation	75	41.1 33.1–51.0ROR 45.0 · χ² 2,897 / p <1e-300	40.7 EB05 33.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 42.9	no trial data cached
Product taste abnormal	12	21.8 12.5–38.3ROR 22.1 · χ² 218 / p 1e-49	21.0 EB05 12.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Myoclonus	10	20.5 11.1–38.0ROR 20.8 · χ² 167 / p 2e-38	19.3 EB05 10.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 131.9	no trial data cached
Therapeutic product effect incomplete	44	15.2 11.4–20.3ROR 16.0 · χ² 573 / p 8e-127	15.0 EB05 11.6 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	77% consumer	no trial data cached
Pharyngeal swelling	5	12.8 5.3–30.6ROR 12.9 · χ² 43 / p 3e-11	8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Migraine	43	11.1 8.3–14.8ROR 11.6 · χ² 386 / p 2e-86	10.7 EB05 8.1 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 51.2	no trial data cached
Burning sensation	31	10.8 7.7–15.3ROR 11.2 · χ² 267 / p 2e-60	10.2 EB05 7.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Sneezing	9	9.8 5.1–18.9ROR 9.9 · χ² 63 / p 1e-15	7.6 EB05 3.9 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Drug effect less than expected	5	8.7 3.6–20.8ROR 8.7 · χ² 27 / p 1e-7	5.5 EB05 2.4 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Therapeutic response shortened	6	4.6 2.1–10.2ROR 4.6 · χ² 14 / p 1e-4	3.6 EB05 1.8 · IC025 +0.4	Reporting / coding artifact	serious PRR 15.3	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
Dysgeusia (altered taste)	248	81.5 73.4–90.6ROR 114.3 · χ² 19,647 / p <1e-300	80.8 EB05 72.7 · IC025 +5.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.6	no trial data cached
Throat irritation	75	41.1 33.1–51.0ROR 45.0 · χ² 2,897 / p <1e-300	40.7 EB05 33.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 42.9	no trial data cached
Therapeutic product effect incomplete	44	15.2 11.4–20.3ROR 16.0 · χ² 573 / p 8e-127	15.0 EB05 11.6 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	77% consumer	no trial data cached
Migraine	43	11.1 8.3–14.8ROR 11.6 · χ² 386 / p 2e-86	10.7 EB05 8.1 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 51.2	no trial data cached
Taste disorder	36	44.0 32.0–60.6ROR 45.9 · χ² 1,470 / p <1e-300	43.0 EB05 32.5 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.6	no trial data cached
Burning sensation	31	10.8 7.7–15.3ROR 11.2 · χ² 267 / p 2e-60	10.2 EB05 7.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Product taste abnormal	12	21.8 12.5–38.3ROR 22.1 · χ² 218 / p 1e-49	21.0 EB05 12.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Myoclonus	10	20.5 11.1–38.0ROR 20.8 · χ² 167 / p 2e-38	19.3 EB05 10.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 131.9	no trial data cached
Sneezing	9	9.8 5.1–18.9ROR 9.9 · χ² 63 / p 1e-15	7.6 EB05 3.9 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Therapeutic response shortened	6	4.6 2.1–10.2ROR 4.6 · χ² 14 / p 1e-4	3.6 EB05 1.8 · IC025 +0.4	Reporting / coding artifact	serious PRR 15.3	no trial data cached
Drug effect less than expected	5	8.7 3.6–20.8ROR 8.7 · χ² 27 / p 1e-7	5.5 EB05 2.4 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Pharyngeal swelling	5	12.8 5.3–30.6ROR 12.9 · χ² 43 / p 3e-11	8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Wrong technique in device usage process	4	2.1 0.8–5.7ROR 2.1 · χ² 1 / p 0.116	1.9 EB05 0.9 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Device defective	3	4.5 1.5–14.0ROR 4.5 · χ² 5 / p 0.012	3.0 EB05 1.2 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	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.

Throat irritation — n=75, PRR 41.1
Burning sensation — n=31, PRR 10.8

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 Zavegepant?

In FDA FAERS, the most frequently co-reported reaction terms for Zavegepant are dysgeusia, throat irritation, migraine, taste disorder, burning sensation, myoclonus. 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 Zavegepant have an FDA boxed warning?

No. The FDA label retrieved for Zavegepant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Zavegepant 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 1191475f-e999-49f4-a805-93ad08596b1b, effective 20251226; matched on openfda.generic_name.exact:"ZAVEGEPANT")
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, field patient.drug.openfda.generic_name.exact, 14 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.