Drug · FAERS side-effect profile with label screen
Almotriptan side effects: what 1,008 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Almotriptan Malate
openFDA label
Who reports
1,008 reports · 90% serious · 48 with death outcome · 54% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Almotriptan tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: • Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) • Acute treatment of migraine headache pain in adolescents age 12 to 1.
FDA label, Indications and Usage
What it is
Almotriptan tablets, USP contain almotriptan malate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine (±)-hydroxybutanedioate (1:1) 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 7Labeled (related wording) 4Likely indication confounding 3Reporting / coding artifact 3Not in label — unassessed 23
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. 30 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 |
|---|---|---|---|---|---|---|
| Sedation | 413 | 334.9 310.7–361.0ROR 566.7 · χ² 135,119 / p <1e-300 | 324.6 EB05 299.1 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 290.7 · ♀ 0% (drug 54%) | no trial data cached |
| Nightmare | 415 | 251.4 233.3–270.8ROR 426.6 · χ² 102,160 / p <1e-300 | 245.5 EB05 226.3 · IC025 +7.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 270.0 · ♀ 1% (drug 54%) | no trial data cached |
| Nephrolithiasis (kidney stones) | 333 | 152.6 139.7–166.7ROR 227.3 · χ² 49,728 / p <1e-300 | 150.2 EB05 137.1 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 106.8 · ♀ 2% (drug 54%) | no trial data cached |
| Hyperhidrosis (excessive sweating) | 448 | 72.5 67.7–77.7ROR 129.7 · χ² 31,611 / p <1e-300 | 72.1 EB05 66.6 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 73.8 · ♀ 9% (drug 54%) | no trial data cached |
| Ligament sprain | 15 | 31.7 19.2–52.4ROR 32.1 · χ² 415 / p 2e-92 | 30.5 EB05 19.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Product use in unapproved indication | 338 | 28.8 26.4–31.4ROR 42.9 · χ² 9,143 / p <1e-300 | 28.7 EB05 26.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 40.5 · ♀ 6% (drug 54%) | no trial data cached |
| Sputum discoloured | 13 | 28.6 16.7–49.2ROR 29.0 · χ² 319 / p 1e-71 | 27.5 EB05 17.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 | no trial data cached |
| Ear discomfort | 13 | 26.5 15.4–45.4ROR 26.8 · χ² 293 / p 5e-66 | 25.5 EB05 15.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Eyelid ptosis | 12 | 24.6 14.0–43.1ROR 24.9 · χ² 248 / p 3e-56 | 23.6 EB05 14.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Temperature intolerance | 12 | 24.5 13.9–43.0ROR 24.8 · χ² 247 / p 6e-56 | 23.5 EB05 14.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Tenderness | 12 | 23.9 13.6–42.0ROR 24.2 · χ² 241 / p 1e-54 | 23.0 EB05 13.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Photophobia (light sensitivity) | 21 | 23.4 15.3–35.8ROR 23.9 · χ² 429 / p 2e-95 | 22.9 EB05 15.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 24.3 · ♀ 100% (drug 54%) | no trial data cached |
| Meningioma | 16 | 22.6 13.9–36.8ROR 23.0 · χ² 309 / p 2e-69 | 22.0 EB05 14.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Coordination abnormal | 15 | 22.2 13.5–36.8ROR 22.6 · χ² 283 / p 8e-64 | 21.6 EB05 13.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.7 | no trial data cached |
| Mydriasis | 12 | 19.5 11.1–34.2ROR 19.7 · χ² 192 / p 5e-44 | 18.6 EB05 10.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 | no trial data cached |
| Seasonal allergy | 12 | 17.7 10.1–31.1ROR 17.9 · χ² 173 / p 1e-39 | 16.7 EB05 9.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Migraine | 79 | 17.3 14.0–21.4ROR 18.7 · χ² 1,204 / p 4e-264 | 17.2 EB05 14.3 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.6 · ♀ 90% (drug 54%) | no trial data cached |
| Therapy partial responder | 12 | 16.6 9.4–29.1ROR 16.8 · χ² 160 / p 4e-37 | 15.5 EB05 8.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 12.9 | no trial data cached |
| Impaired quality of life | 11 | 15.9 8.8–28.6ROR 16.1 · χ² 139 / p 2e-32 | 14.6 EB05 7.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 | no trial data cached |
| Apathy | 11 | 15.8 8.8–28.4ROR 15.9 · χ² 138 / p 4e-32 | 14.4 EB05 7.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 | no trial data cached |
| Joint range of motion decreased | 10 | 15.6 8.4–28.9ROR 15.7 · χ² 122 / p 1e-28 | 13.9 EB05 6.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Impaired work ability | 16 | 15.5 9.5–25.3ROR 15.8 · χ² 203 / p 2e-46 | 14.8 EB05 9.0 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 | no trial data cached |
| Amenorrhoea (missed periods) | 12 | 15.0 8.5–26.3ROR 15.1 · χ² 143 / p 3e-33 | 13.7 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 21.9 | no trial data cached |
| Disability | 14 | 14.7 8.8–24.8ROR 14.9 · χ² 166 / p 3e-38 | 13.7 EB05 7.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Ear pain | 13 | 13.9 8.1–23.9ROR 14.1 · χ² 143 / p 3e-33 | 12.7 EB05 7.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Serotonin syndrome | 12 | 13.1 7.4–22.9ROR 13.2 · χ² 122 / p 1e-28 | 11.5 EB05 6.2 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | no trial data cached |
| Neck pain | 34 | 12.6 9.1–17.6ROR 13.1 · χ² 354 / p 3e-79 | 12.2 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · ♀ 100% (drug 54%) | no trial data cached |
| Upper limb fracture | 12 | 12.5 7.1–21.9ROR 12.6 · χ² 116 / p 3e-27 | 10.9 EB05 5.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Hypocalcaemia (low calcium) | 11 | 12.1 6.7–21.8ROR 12.3 · χ² 101 / p 4e-24 | 10.3 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Night sweats | 18 | 11.6 7.4–18.4ROR 11.8 · χ² 165 / p 5e-38 | 10.6 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Throat tightness | 14 | 10.8 6.4–18.1ROR 10.9 · χ² 115 / p 4e-27 | 9.3 EB05 5.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.9 | no trial data cached |
| Nausea | 402 | 10.6 9.8–11.4ROR 17.0 · χ² 3,622 / p <1e-300 | 10.6 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.0 · ♀ 20% (drug 54%) | no trial data cached |
| Epilepsy | 15 | 10.2 6.2–16.9ROR 10.4 · χ² 116 / p 2e-27 | 8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Muscle twitching | 11 | 9.9 5.5–17.8ROR 10.0 · χ² 79 / p 3e-19 | 8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Poor quality sleep | 10 | 9.7 5.2–18.0ROR 9.8 · χ² 70 / p 3e-17 | 7.7 EB05 4.1 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 | no trial data cached |
| Diplopia (double vision) | 12 | 9.6 5.5–16.9ROR 9.7 · χ² 84 / p 2e-20 | 7.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | no trial data cached |
| Limb discomfort | 12 | 8.1 4.6–14.2ROR 8.2 · χ² 67 / p 1e-16 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Joint stiffness | 10 | 7.9 4.3–14.7ROR 8.0 · χ² 54 / p 1e-13 | 6.2 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Crying | 13 | 7.4 4.3–12.7ROR 7.5 · χ² 66 / p 2e-16 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Nervous system disorder | 11 | 7.3 4.1–13.2ROR 7.4 · χ² 54 / p 1e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | 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 |
|---|---|---|---|---|---|---|
| Hyperhidrosis (excessive sweating) | 448 | 72.5 67.7–77.7ROR 129.7 · χ² 31,611 / p <1e-300 | 72.1 EB05 66.6 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 73.8 · ♀ 9% (drug 54%) | no trial data cached |
| Nightmare | 415 | 251.4 233.3–270.8ROR 426.6 · χ² 102,160 / p <1e-300 | 245.5 EB05 226.3 · IC025 +7.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 270.0 · ♀ 1% (drug 54%) | no trial data cached |
| Sedation | 413 | 334.9 310.7–361.0ROR 566.7 · χ² 135,119 / p <1e-300 | 324.6 EB05 299.1 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious PRR 290.7 · ♀ 0% (drug 54%) | no trial data cached |
| Nausea | 402 | 10.6 9.8–11.4ROR 17.0 · χ² 3,622 / p <1e-300 | 10.6 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.0 · ♀ 20% (drug 54%) | no trial data cached |
| Product use in unapproved indication | 338 | 28.8 26.4–31.4ROR 42.9 · χ² 9,143 / p <1e-300 | 28.7 EB05 26.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 40.5 · ♀ 6% (drug 54%) | no trial data cached |
| Nephrolithiasis (kidney stones) | 333 | 152.6 139.7–166.7ROR 227.3 · χ² 49,728 / p <1e-300 | 150.2 EB05 137.1 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 106.8 · ♀ 2% (drug 54%) | no trial data cached |
| Migraine | 79 | 17.3 14.0–21.4ROR 18.7 · χ² 1,204 / p 4e-264 | 17.2 EB05 14.3 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.6 · ♀ 90% (drug 54%) | no trial data cached |
| Neck pain | 34 | 12.6 9.1–17.6ROR 13.1 · χ² 354 / p 3e-79 | 12.2 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · ♀ 100% (drug 54%) | no trial data cached |
| Maternal exposure during pregnancy | 25 | 5.9 4.0–8.7ROR 6.0 · χ² 97 / p 3e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · ♀ 95% (drug 54%) · 100% clinician | no trial data cached |
| Photophobia (light sensitivity) | 21 | 23.4 15.3–35.8ROR 23.9 · χ² 429 / p 2e-95 | 22.9 EB05 15.8 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 24.3 · ♀ 100% (drug 54%) | no trial data cached |
| Drug abuse | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 45 / p 8e-12 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Night sweats | 18 | 11.6 7.4–18.4ROR 11.8 · χ² 165 / p 5e-38 | 10.6 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Completed suicide (death by suicide) | 16 | 4.0 2.4–6.4ROR 4.0 · χ² 33 / p 6e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.5 | no trial data cached |
| Impaired work ability | 16 | 15.5 9.5–25.3ROR 15.8 · χ² 203 / p 2e-46 | 14.8 EB05 9.0 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 | no trial data cached |
| Meningioma | 16 | 22.6 13.9–36.8ROR 23.0 · χ² 309 / p 2e-69 | 22.0 EB05 14.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | 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.
- Sedation — n=413, PRR 334.9
- Nephrolithiasis — n=333, PRR 152.6
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 Almotriptan?
In FDA FAERS, the most frequently co-reported reaction terms for Almotriptan are hyperhidrosis, nightmare, sedation, nausea, nephrolithiasis, migraine. 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 Almotriptan have an FDA boxed warning?
No. The FDA label retrieved for Almotriptan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Almotriptan 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 35617039-9f33-401b-bac3-8f85c65fa2c7, effective 20170509; matched on
openfda.generic_name.exact:"ALMOTRIPTAN") - 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, 70 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.