Naratriptan side effects: what 1,369 FDA adverse event reports show

Naratriptan · 62 reaction terms · 705 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,369 reports · 56% serious · 20 with death outcome · 87% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks.

FDA label, Indications and Usage

What it is

Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT 1B/1D receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following 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 21 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 6Not in label — unassessed 8

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.
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. 41 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
Red blood cell sedimentation rate increased	24	33.2 22.3–49.4ROR 33.8 · χ² 717 / p 3e-158	32.4 EB05 22.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 38.4	no trial data cached
Oesophagitis	18	25.2 15.9–40.0ROR 25.6 · χ² 395 / p 4e-88	24.6 EB05 16.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.6	no trial data cached
Lymphocyte count decreased	26	22.5 15.4–33.0ROR 23.0 · χ² 514 / p 5e-114	22.2 EB05 15.9 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious PRR 28.2	no trial data cached
Subarachnoid haemorrhage	14	21.0 12.5–35.4ROR 21.2 · χ² 247 / p 6e-56	20.3 EB05 12.5 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.5	no trial data cached
Blood lactate dehydrogenase increased	20	19.2 12.4–29.7ROR 19.5 · χ² 328 / p 2e-73	18.8 EB05 12.7 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 20.9	no trial data cached
Migraine	117	18.9 15.9–22.5ROR 20.6 · χ² 1,973 / p <1e-300	18.8 EB05 16.1 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.3	no trial data cached
Gamma-glutamyltransferase increased	21	14.5 9.5–22.2ROR 14.7 · χ² 251 / p 8e-57	13.9 EB05 9.2 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 15.4	no trial data cached
Blood alkaline phosphatase increased	22	13.6 9.0–20.5ROR 13.8 · χ² 244 / p 3e-55	12.9 EB05 8.6 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 15.9	no trial data cached
Hepatitis (liver inflammation)	21	12.6 8.2–19.2ROR 12.8 · χ² 212 / p 2e-48	11.8 EB05 7.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
C-reactive protein increased	22	9.3 6.1–14.0ROR 9.4 · χ² 154 / p 1e-35	8.3 EB05 5.6 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 9.8	no trial data cached
Dystonia	11	8.7 4.8–15.6ROR 8.7 · χ² 67 / p 1e-16	6.9 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.9	no trial data cached
Therapeutic product effect decreased	18	6.2 3.9–9.8ROR 6.3 · χ² 74 / p 4e-18	5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.0	no trial data cached
Product substitution issue	20	5.3 3.4–8.2ROR 5.4 · χ² 66 / p 2e-16	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	no trial data cached
Therapeutic response shortened	10	4.8 2.6–8.9ROR 4.8 · χ² 27 / p 1e-7	4.0 EB05 2.4 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial data cached
Foetal exposure during pregnancy	23	4.3 2.9–6.5ROR 4.4 · χ² 56 / p 4e-14	4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5	no trial data cached
Underdose	19	4.0 2.5–6.2ROR 4.0 · χ² 40 / p 2e-10	3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.7	no trial data cached
Injection site pruritus	12	2.8 1.6–4.9ROR 2.8 · χ² 12 / p 3e-4	2.6 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 1.7	no trial data cached
Multiple sclerosis relapse	12	2.7 1.5–4.7ROR 2.7 · χ² 11 / p 5e-4	2.5 EB05 1.5 · IC025 +0.3	Not in label — unassessed	serious PRR 3.5	no trial data cached
Injection site bruising	13	2.5 1.5–4.3ROR 2.5 · χ² 11 / p 6e-4	2.4 EB05 1.5 · IC025 +0.3	Not in label — unassessed	serious PRR 4.8	no trial data cached
Suicide attempt	10	2.5 1.4–4.7ROR 2.5 · χ² 8 / p 0.003	2.4 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 2.6	no trial data cached
Injection site reaction	11	2.5 1.4–4.4ROR 2.5 · χ² 8 / p 0.002	2.3 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 7.1	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	117	18.9 15.9–22.5ROR 20.6 · χ² 1,973 / p <1e-300	18.8 EB05 16.1 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.3	no trial data cached
Lymphocyte count decreased	26	22.5 15.4–33.0ROR 23.0 · χ² 514 / p 5e-114	22.2 EB05 15.9 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious PRR 28.2	no trial data cached
Red blood cell sedimentation rate increased	24	33.2 22.3–49.4ROR 33.8 · χ² 717 / p 3e-158	32.4 EB05 22.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 38.4	no trial data cached
Foetal exposure during pregnancy	23	4.3 2.9–6.5ROR 4.4 · χ² 56 / p 4e-14	4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5	no trial data cached
C-reactive protein increased	22	9.3 6.1–14.0ROR 9.4 · χ² 154 / p 1e-35	8.3 EB05 5.6 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 9.8	no trial data cached
Blood alkaline phosphatase increased	22	13.6 9.0–20.5ROR 13.8 · χ² 244 / p 3e-55	12.9 EB05 8.6 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 15.9	no trial data cached
Hepatitis (liver inflammation)	21	12.6 8.2–19.2ROR 12.8 · χ² 212 / p 2e-48	11.8 EB05 7.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Gamma-glutamyltransferase increased	21	14.5 9.5–22.2ROR 14.7 · χ² 251 / p 8e-57	13.9 EB05 9.2 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	serious PRR 15.4	no trial data cached
Product substitution issue	20	5.3 3.4–8.2ROR 5.4 · χ² 66 / p 2e-16	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	no trial data cached
Blood lactate dehydrogenase increased	20	19.2 12.4–29.7ROR 19.5 · χ² 328 / p 2e-73	18.8 EB05 12.7 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 20.9	no trial data cached
Underdose	19	4.0 2.5–6.2ROR 4.0 · χ² 40 / p 2e-10	3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.7	no trial data cached
Therapeutic product effect decreased	18	6.2 3.9–9.8ROR 6.3 · χ² 74 / p 4e-18	5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.0	no trial data cached
Oesophagitis	18	25.2 15.9–40.0ROR 25.6 · χ² 395 / p 4e-88	24.6 EB05 16.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 28.6	no trial data cached
Injection site erythema (redness where injected)	15	1.9 1.1–3.1ROR 1.9 · χ² 5 / p 0.011	1.8 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 2.3	no trial data cached
Subarachnoid haemorrhage	14	21.0 12.5–35.4ROR 21.2 · χ² 247 / p 6e-56	20.3 EB05 12.5 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.5	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.

Hepatitis — n=21, PRR 12.6

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 Naratriptan?

In FDA FAERS, the most frequently co-reported reaction terms for Naratriptan are migraine, lymphocyte count decreased, red blood cell sedimentation rate increased, c-reactive protein increased, blood alkaline phosphatase increased, hepatitis. 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 Naratriptan have an FDA boxed warning?

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

Do FAERS signals prove that Naratriptan 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 93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda, effective 20260630; matched on openfda.generic_name.exact:"NARATRIPTAN")
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, 62 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.