Drug · FAERS side-effect profile with label screen
Eletriptan Hydrobromide side effects: what 6,995 FDA adverse event reports show
Drug class
Not stated in label
Who reports
6,995 reports · 52% serious · 97 with death outcome · 88% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Eletriptan hydrobromide 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 a.
FDA label, Indications and Usage
What it is
Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Eletriptan hydrobromide is chemically designated.
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 3Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 4Not 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. 453 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 |
|---|---|---|---|---|---|---|
| Migraine | 858 | 27.3 25.7–29.1ROR 31.0 · χ² 21,648 / p <1e-300 | 27.1 EB05 25.6 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 26.6 | no trial data cached |
| Fibromyalgia | 58 | 7.2 5.5–9.3ROR 7.2 · χ² 301 / p 8e-68 | 6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Breast pain | 23 | 6.5 4.3–9.7ROR 6.5 · χ² 101 / p 5e-24 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Muscle tightness | 33 | 6.1 4.4–8.6ROR 6.1 · χ² 136 / p 9e-32 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Throat tightness | 55 | 6.1 4.7–8.0ROR 6.2 · χ² 230 / p 3e-52 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Impaired driving ability | 23 | 6.1 4.0–9.1ROR 6.1 · χ² 92 / p 4e-22 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 76% consumer | no trial data cached |
| Therapy partial responder | 29 | 5.8 4.0–8.3ROR 5.8 · χ² 110 / p 6e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · ♀ 0% (drug 88%) · 100% clinician | no trial data cached |
| Impaired work ability | 40 | 5.6 4.1–7.6ROR 5.6 · χ² 146 / p 5e-34 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 83% consumer | no trial data cached |
| Hereditary angioedema | 19 | 5.4 3.5–8.5ROR 5.4 · χ² 64 / p 6e-16 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Sleep apnoea syndrome | 34 | 5.3 3.8–7.5ROR 5.4 · χ² 115 / p 3e-27 | 5.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Photophobia (light sensitivity) | 33 | 5.3 3.8–7.5ROR 5.3 · χ² 111 / p 3e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Gallbladder disorder | 31 | 5.2 3.7–7.4ROR 5.2 · χ² 101 / p 5e-24 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Drug effect incomplete | 63 | 5.1 4.0–6.6ROR 5.2 · χ² 205 / p 7e-47 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 74% consumer | no trial data cached |
| Neck pain | 91 | 4.9 4.0–6.0ROR 4.9 · χ² 277 / p 2e-62 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Serotonin syndrome | 30 | 4.7 3.3–6.7ROR 4.7 · χ² 84 / p 3e-20 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Drug dispensing error | 23 | 4.5 3.0–6.7ROR 4.5 · χ² 58 / p 1e-14 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Spinal disorder | 14 | 4.4 2.6–7.5ROR 4.4 · χ² 34 / p 3e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Seasonal allergy | 20 | 4.3 2.7–6.6ROR 4.3 · χ² 46 / p 5e-12 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 23 | 4.2 2.8–6.3ROR 4.2 · χ² 53 / p 2e-13 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Brain injury | 14 | 4.2 2.5–7.1ROR 4.2 · χ² 31 / p 1e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Activities of daily living impaired | 28 | 4.2 2.9–6.1ROR 4.2 · χ² 65 / p 5e-16 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Autoimmune disorder | 13 | 4.1 2.4–7.0ROR 4.1 · χ² 27 / p 1e-7 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Immunodeficiency | 20 | 4.1 2.6–6.3ROR 4.1 · χ² 43 / p 2e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Road traffic accident | 56 | 4.0 3.1–5.2ROR 4.0 · χ² 124 / p 5e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Coeliac disease | 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 | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Stress | 94 | 3.9 3.2–4.8ROR 4.0 · χ² 202 / p 4e-46 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Bladder disorder | 13 | 3.9 2.3–6.7ROR 3.9 · χ² 25 / p 2e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Product packaging issue | 12 | 3.9 2.2–6.8ROR 3.9 · χ² 23 / p 9e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Intervertebral disc degeneration | 12 | 3.9 2.2–6.8ROR 3.9 · χ² 23 / p 9e-7 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Back disorder | 21 | 3.9 2.5–5.9ROR 3.9 · χ² 42 / p 6e-11 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Nerve injury | 14 | 3.8 2.2–6.4ROR 3.8 · χ² 26 / p 2e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Intervertebral disc protrusion | 27 | 3.7 2.5–5.4ROR 3.7 · χ² 50 / p 6e-13 | 3.5 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 75% consumer | no trial data cached |
| Pharyngeal oedema | 19 | 3.7 2.3–5.7ROR 3.7 · χ² 34 / p 3e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Sinus disorder | 24 | 3.6 2.4–5.4ROR 3.6 · χ² 43 / p 3e-11 | 3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 82% consumer | no trial data cached |
| Body height decreased | 13 | 3.6 2.1–6.2ROR 3.6 · χ² 22 / p 1e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Bipolar disorder | 13 | 3.6 2.1–6.1ROR 3.6 · χ² 21 / p 2e-6 | 3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Chest discomfort | 121 | 3.6 3.0–4.2ROR 3.6 · χ² 221 / p 3e-50 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Motor dysfunction | 12 | 3.6 2.0–6.3ROR 3.6 · χ² 20 / p 5e-6 | 3.2 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Retching | 25 | 3.5 2.4–5.2ROR 3.5 · χ² 43 / p 3e-11 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Subarachnoid haemorrhage | 12 | 3.5 2.0–6.2ROR 3.5 · χ² 19 / p 6e-6 | 3.2 EB05 2.0 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 3.9 | 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) | 912 | 2.1 2.0–2.2ROR 2.2 · χ² 542 / p 4e-120 | 2.1 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Migraine | 858 | 27.3 25.7–29.1ROR 31.0 · χ² 21,648 / p <1e-300 | 27.1 EB05 25.6 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 26.6 | no trial data cached |
| Headache | 732 | 3.5 3.3–3.8ROR 3.8 · χ² 1,348 / p 2e-295 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.7 | no trial data cached |
| Nausea | 499 | 1.9 1.7–2.1ROR 2.0 · χ² 219 / p 1e-49 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Pain | 424 | 2.1 1.9–2.3ROR 2.1 · χ² 239 / p 3e-54 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Vomiting | 328 | 2.1 1.9–2.3ROR 2.2 · χ² 191 / p 8e-44 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Malaise (feeling unwell) | 288 | 2.0 1.8–2.2ROR 2.0 · χ² 138 / p 3e-32 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Dizziness | 267 | 1.6 1.4–1.8ROR 1.6 · χ² 62 / p 2e-15 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Anxiety | 220 | 2.3 2.0–2.6ROR 2.4 · χ² 165 / p 6e-38 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Feeling abnormal | 213 | 2.7 2.3–3.0ROR 2.7 · χ² 220 / p 4e-50 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Insomnia (trouble sleeping) | 201 | 2.3 2.0–2.6ROR 2.3 · χ² 141 / p 6e-33 | 2.3 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Condition aggravated | 197 | 2.0 1.7–2.2ROR 2.0 · χ² 92 / p 4e-22 | 2.0 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Paraesthesia (tingling/numbness) | 181 | 3.4 3.0–4.0ROR 3.5 · χ² 313 / p 2e-70 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Somnolence (drowsiness) | 174 | 2.6 2.2–3.0ROR 2.6 · χ² 171 / p 3e-39 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Drug hypersensitivity | 147 | 2.3 1.9–2.7ROR 2.3 · χ² 104 / p 1e-24 | 2.3 EB05 2.0 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 1.6 | 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.
- Fibromyalgia — n=58, PRR 7.2
- Breast pain — n=23, PRR 6.5
- Muscle tightness — n=33, PRR 6.1
- Impaired driving ability — n=23, PRR 6.1
- Impaired work ability — n=40, PRR 5.6
- Sleep apnoea syndrome — n=34, PRR 5.3
- Photophobia — n=33, PRR 5.3
- Gallbladder disorder — n=31, PRR 5.2
- Seasonal allergy — n=20, PRR 4.3
- Photosensitivity reaction — n=23, PRR 4.2
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 Eletriptan Hydrobromide?
In FDA FAERS, the most frequently co-reported reaction terms for Eletriptan Hydrobromide are migraine, headache, nausea, pain, vomiting, malaise. 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 Eletriptan Hydrobromide have an FDA boxed warning?
No. The FDA label retrieved for Eletriptan Hydrobromide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Eletriptan Hydrobromide 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 20276f5c-f2d6-469f-9a1b-aa254a1db21c, effective 20200415; matched on
openfda.generic_name.exact:"ELETRIPTAN HYDROBROMIDE") - 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, 493 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.