Almotriptan Malate side effects: what 502 FDA adverse event reports show

Almotriptan Malate · 33 reaction terms · 1,778 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

502 reports · 92% serious · 12 with death outcome · 37% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Almotriptan malate 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 t.

FDA label, Indications and Usage

What it is

Almotriptan malate tablets contain almotriptan malate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethyla.

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 25 strongest signals

Labeled adverse reaction 4Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 17

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. 8 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
Sedation	315	510.9 477.1–547.2ROR 1,369.9 · χ² 158,042 / p <1e-300	489.6 EB05 445.9 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious PRR 434.3 · ♀ 0% (drug 37%)	no trial data cached
Nightmare	315	382.0 356.8–409.0ROR 1,023.8 · χ² 118,420 / p <1e-300	370.0 EB05 336.9 · IC025 +7.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 401.4 · ♀ 0% (drug 37%)	no trial data cached
Nephrolithiasis (kidney stones)	282	259.1 239.7–280.1ROR 590.0 · χ² 71,962 / p <1e-300	253.1 EB05 229.3 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 177.2 · ♀ 1% (drug 37%)	no trial data cached
Hyperhidrosis (excessive sweating)	330	107.2 100.6–114.2ROR 310.9 · χ² 34,726 / p <1e-300	106.2 EB05 97.0 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 106.3 · ♀ 6% (drug 37%)	no trial data cached
Ligament sprain	14	59.3 35.4–99.5ROR 61.0 · χ² 745 / p 2e-164	55.1 EB05 34.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Eyelid ptosis	12	49.3 28.2–86.3ROR 50.5 · χ² 521 / p 2e-115	45.9 EB05 28.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Tenderness	12	48.1 27.5–84.1ROR 49.2 · χ² 507 / p 2e-112	44.8 EB05 27.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Meningioma	16	45.4 28.0–73.6ROR 46.9 · χ² 651 / p 6e-144	43.2 EB05 28.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 28.3	no trial data cached
Photophobia (light sensitivity)	18	40.3 25.6–63.5ROR 41.8 · χ² 651 / p 6e-144	38.8 EB05 25.9 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 40.7	no trial data cached
Product use in unapproved indication	232	39.7 36.1–43.6ROR 73.0 · χ² 8,809 / p <1e-300	39.6 EB05 35.5 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 55.2 · ♀ 3% (drug 37%)	no trial data cached
Mydriasis	12	39.1 22.4–68.5ROR 40.1 · χ² 408 / p 4e-91	37.0 EB05 22.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 31.6	no trial data cached
Coordination abnormal	12	35.7 20.4–62.5ROR 36.6 · χ² 371 / p 6e-83	33.9 EB05 20.7 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 30.9	no trial data cached
Impaired quality of life	11	32.0 17.8–57.3ROR 32.6 · χ² 300 / p 2e-67	30.4 EB05 18.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 29.6	no trial data cached
Apathy	11	31.6 17.6–56.8ROR 32.3 · χ² 297 / p 9e-67	30.1 EB05 17.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 28.6	no trial data cached
Amenorrhoea (missed periods)	12	30.0 17.2–52.6ROR 30.8 · χ² 309 / p 2e-69	28.8 EB05 17.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 42.9	no trial data cached
Disability	14	29.6 17.6–49.6ROR 30.4 · χ² 359 / p 3e-80	28.5 EB05 18.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Impaired work ability	14	27.3 16.3–45.7ROR 28.0 · χ² 329 / p 9e-74	26.4 EB05 16.6 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.8	no trial data cached
Upper limb fracture	12	25.1 14.3–43.8ROR 25.6 · χ² 254 / p 2e-57	24.1 EB05 14.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.9	no trial data cached
Hypocalcaemia (low calcium)	11	24.4 13.6–43.7ROR 24.9 · χ² 224 / p 7e-51	23.3 EB05 13.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Night sweats	16	20.8 12.8–33.6ROR 21.4 · χ² 282 / p 1e-63	20.2 EB05 13.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.3	no trial data cached
Muscle twitching	11	19.9 11.1–35.7ROR 20.3 · χ² 179 / p 4e-41	18.8 EB05 10.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 19.3	no trial data cached
Diplopia (double vision)	12	19.3 11.0–33.8ROR 19.8 · χ² 191 / p 1e-43	18.4 EB05 10.6 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.5	no trial data cached
Epilepsy	13	17.8 10.4–30.4ROR 18.2 · χ² 190 / p 2e-43	16.9 EB05 9.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Nervous system disorder	11	14.7 8.2–26.3ROR 15.0 · χ² 127 / p 9e-30	13.2 EB05 6.8 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.2	no trial data cached
Crying	11	12.6 7.0–22.6ROR 12.9 · χ² 106 / p 3e-25	10.8 EB05 5.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	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)	330	107.2 100.6–114.2ROR 310.9 · χ² 34,726 / p <1e-300	106.2 EB05 97.0 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 106.3 · ♀ 6% (drug 37%)	no trial data cached
Nightmare	315	382.0 356.8–409.0ROR 1,023.8 · χ² 118,420 / p <1e-300	370.0 EB05 336.9 · IC025 +7.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 401.4 · ♀ 0% (drug 37%)	no trial data cached
Sedation	315	510.9 477.1–547.2ROR 1,369.9 · χ² 158,042 / p <1e-300	489.6 EB05 445.9 · IC025 +7.9 3/3 methods agree	Not in label — unassessed	serious PRR 434.3 · ♀ 0% (drug 37%)	no trial data cached
Nephrolithiasis (kidney stones)	282	259.1 239.7–280.1ROR 590.0 · χ² 71,962 / p <1e-300	253.1 EB05 229.3 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 177.2 · ♀ 1% (drug 37%)	no trial data cached
Product use in unapproved indication	232	39.7 36.1–43.6ROR 73.0 · χ² 8,809 / p <1e-300	39.6 EB05 35.5 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 55.2 · ♀ 3% (drug 37%)	no trial data cached
Photophobia (light sensitivity)	18	40.3 25.6–63.5ROR 41.8 · χ² 651 / p 6e-144	38.8 EB05 25.9 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 40.7	no trial data cached
Night sweats	16	20.8 12.8–33.6ROR 21.4 · χ² 282 / p 1e-63	20.2 EB05 13.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.3	no trial data cached
Meningioma	16	45.4 28.0–73.6ROR 46.9 · χ² 651 / p 6e-144	43.2 EB05 28.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 28.3	no trial data cached
Impaired work ability	14	27.3 16.3–45.7ROR 28.0 · χ² 329 / p 9e-74	26.4 EB05 16.6 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.8	no trial data cached
Disability	14	29.6 17.6–49.6ROR 30.4 · χ² 359 / p 3e-80	28.5 EB05 18.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Ligament sprain	14	59.3 35.4–99.5ROR 61.0 · χ² 745 / p 2e-164	55.1 EB05 34.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Epilepsy	13	17.8 10.4–30.4ROR 18.2 · χ² 190 / p 2e-43	16.9 EB05 9.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Diplopia (double vision)	12	19.3 11.0–33.8ROR 19.8 · χ² 191 / p 1e-43	18.4 EB05 10.6 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.5	no trial data cached
Upper limb fracture	12	25.1 14.3–43.8ROR 25.6 · χ² 254 / p 2e-57	24.1 EB05 14.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.9	no trial data cached
Amenorrhoea (missed periods)	12	30.0 17.2–52.6ROR 30.8 · χ² 309 / p 2e-69	28.8 EB05 17.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 42.9	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=315, PRR 510.9
Nephrolithiasis — n=282, PRR 259.1

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 Malate?

In FDA FAERS, the most frequently co-reported reaction terms for Almotriptan Malate are hyperhidrosis, nightmare, sedation, nephrolithiasis, photophobia, night sweats. 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 Malate have an FDA boxed warning?

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

Do FAERS signals prove that Almotriptan Malate 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 c41a4579-9db0-402b-81b1-0adf5b3978c3, effective 20170531; matched on openfda.generic_name.exact:"ALMOTRIPTAN MALATE")
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, 33 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.