Drug · FAERS side-effect profile with label screen

Methamphetamine side effects: what 1,074 FDA adverse event reports show

Methamphetamine Hydrochloride · 40 reaction terms · 1,306 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Methamphetamine Hydrochloride (Methamphetamine Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,074 reports · 94% serious · 747 with death outcome · 38% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Methamphetamine hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. • Methamphetamine hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. ( 1 )

FDA label, Indications and Usage

What it is

Methamphetamine hydrochloride, USP, chemically known as (αS)-α-Methylbenzeneethan-(N-methyl)-amine Hydrochloride, is a member of the amphetamine group of sympathomimetic amines. It has the fol.

FDA label, Description section

Boxed warning

Methamphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methamphetamine, can result.

FDA 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 — boxed warning 2Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 7Outcome field, not a reaction 1Not in label — unassessed 8

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 15 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
Drug abuse	238	55.7 49.8–62.3ROR 71.3 · χ² 12,746 / p <1e-300	55.3 EB05 49.7 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious PRR 34.2 · 92% clinician	no trial data cached
Drug toxicity	39	55.3 40.6–75.3ROR 57.3 · χ² 2,020 / p <1e-300	53.7 EB05 41.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 35.2 · 94% clinician	no trial data cached
Respiratory depression	29	46.3 32.3–66.3ROR 47.5 · χ² 1,238 / p 2e-271	44.9 EB05 32.8 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 29.2 · 96% clinician	no trial data cached
Respiratory arrest	65	45.7 36.1–57.9ROR 48.6 · χ² 2,797 / p <1e-300	45.1 EB05 36.6 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.1 · 100% clinician	no trial data cached
Pulmonary congestion	24	35.5 23.9–52.7ROR 36.2 · χ² 769 / p 2e-169	34.5 EB05 24.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.3	no trial data cached
Serotonin syndrome	32	32.7 23.2–46.0ROR 33.7 · χ² 952 / p 3e-209	32.1 EB05 23.8 · IC025 +3.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 20.2 · 100% clinician	no trial data cached
Intentional drug misuse	34	31.3 22.5–43.6ROR 32.3 · χ² 968 / p 8e-213	30.8 EB05 23.1 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 34.4 · 93% clinician	no trial data cached
Toxicity to various agents	268	31.2 28.1–34.6ROR 41.3 · χ² 7,861 / p <1e-300	31.1 EB05 28.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.5 · 93% clinician	no trial data cached
Poisoning	19	29.4 18.8–46.0ROR 30.0 · χ² 493 / p 1e-109	28.6 EB05 19.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Hepatitis c	16	25.6 15.7–41.7ROR 26.0 · χ² 354 / p 3e-79	24.9 EB05 16.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.8	no trial data cached
Cardio-respiratory arrest	47	21.8 16.5–28.9ROR 22.8 · χ² 914 / p 4e-201	21.6 EB05 16.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 100% clinician	no trial data cached
Completed suicide (death by suicide)	90	20.9 17.2–25.5ROR 22.7 · χ² 1,691 / p <1e-300	20.8 EB05 17.4 · IC025 +3.9 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 12.8 · 99% clinician	no trial data cached
Cardiac arrest (heart stopping)	71	16.7 13.4–21.0ROR 17.9 · χ² 1,039 / p 4e-228	16.6 EB05 13.6 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.3 · 99% clinician	no trial data cached
Pulmonary oedema	34	14.8 10.6–20.6ROR 15.3 · χ² 425 / p 1e-94	14.5 EB05 10.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · 97% clinician	no trial data cached
Aggression	28	10.9 7.6–15.7ROR 11.2 · χ² 243 / p 6e-55	10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.2 · ♀ 15% (drug 38%)	no trial data cached
Psychotic disorder	15	9.9 6.0–16.4ROR 10.0 · χ² 112 / p 2e-26	8.5 EB05 5.2 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.6	no trial data cached
Unresponsive to stimuli	13	9.9 5.7–16.9ROR 10.0 · χ² 95 / p 9e-23	8.3 EB05 4.8 · IC025 +2.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 6.2	no trial data cached
Rhabdomyolysis (muscle breakdown)	18	8.4 5.3–13.4ROR 8.6 · χ² 111 / p 3e-26	7.3 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 5.2	no trial data cached
Road traffic accident	18	8.4 5.3–13.3ROR 8.5 · χ² 110 / p 4e-26	7.3 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Accidental overdose	15	8.0 4.8–13.2ROR 8.1 · χ² 85 / p 1e-20	6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 8.1	no trial data cached
Suicide attempt	16	5.1 3.2–8.4ROR 5.2 · χ² 49 / p 1e-12	4.5 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.2	no trial data cached
Overdose	50	4.5 3.4–5.9ROR 4.7 · χ² 134 / p 2e-31	4.3 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Intentional overdose	11	3.4 1.9–6.1ROR 3.4 · χ² 16 / p 3e-5	3.0 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	serious PRR 2.1	no trial data cached
Foetal exposure during pregnancy	14	3.4 2.0–5.7ROR 3.4 · χ² 21 / p 2e-6	3.1 EB05 2.0 · IC025 +0.7	Reporting / coding artifact	serious PRR 2.1	no trial data cached
Drug dependence	23	2.8 1.8–4.1ROR 2.8 · χ² 24 / p 4e-7	2.7 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 1.7	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
Toxicity to various agents	268	31.2 28.1–34.6ROR 41.3 · χ² 7,861 / p <1e-300	31.1 EB05 28.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.5 · 93% clinician	no trial data cached
Drug abuse	238	55.7 49.8–62.3ROR 71.3 · χ² 12,746 / p <1e-300	55.3 EB05 49.7 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious PRR 34.2 · 92% clinician	no trial data cached
Completed suicide (death by suicide)	90	20.9 17.2–25.5ROR 22.7 · χ² 1,691 / p <1e-300	20.8 EB05 17.4 · IC025 +3.9 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 12.8 · 99% clinician	no trial data cached
Cardiac arrest (heart stopping)	71	16.7 13.4–21.0ROR 17.9 · χ² 1,039 / p 4e-228	16.6 EB05 13.6 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.3 · 99% clinician	no trial data cached
Respiratory arrest	65	45.7 36.1–57.9ROR 48.6 · χ² 2,797 / p <1e-300	45.1 EB05 36.6 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 28.1 · 100% clinician	no trial data cached
Overdose	50	4.5 3.4–5.9ROR 4.7 · χ² 134 / p 2e-31	4.3 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Cardio-respiratory arrest	47	21.8 16.5–28.9ROR 22.8 · χ² 914 / p 4e-201	21.6 EB05 16.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 13.4 · 100% clinician	no trial data cached
Drug toxicity	39	55.3 40.6–75.3ROR 57.3 · χ² 2,020 / p <1e-300	53.7 EB05 41.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 35.2 · 94% clinician	no trial data cached
Pulmonary oedema	34	14.8 10.6–20.6ROR 15.3 · χ² 425 / p 1e-94	14.5 EB05 10.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · 97% clinician	no trial data cached
Intentional drug misuse	34	31.3 22.5–43.6ROR 32.3 · χ² 968 / p 8e-213	30.8 EB05 23.1 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 34.4 · 93% clinician	no trial data cached
Serotonin syndrome	32	32.7 23.2–46.0ROR 33.7 · χ² 952 / p 3e-209	32.1 EB05 23.8 · IC025 +3.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 20.2 · 100% clinician	no trial data cached
Respiratory depression	29	46.3 32.3–66.3ROR 47.5 · χ² 1,238 / p 2e-271	44.9 EB05 32.8 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 29.2 · 96% clinician	no trial data cached
Aggression	28	10.9 7.6–15.7ROR 11.2 · χ² 243 / p 6e-55	10.2 EB05 7.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.2 · ♀ 15% (drug 38%)	no trial data cached
Pulmonary congestion	24	35.5 23.9–52.7ROR 36.2 · χ² 769 / p 2e-169	34.5 EB05 24.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.3	no trial data cached
Drug dependence	23	2.8 1.8–4.1ROR 2.8 · χ² 24 / p 4e-7	2.7 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 1.7	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.

Drug toxicity — n=39, PRR 55.3
Pulmonary congestion — n=24, PRR 35.5
Toxicity to various agents — n=268, PRR 31.2
Cardio-respiratory arrest — n=47, PRR 21.8
Pulmonary oedema — n=34, PRR 14.8

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 Methamphetamine?

In FDA FAERS, the most frequently co-reported reaction terms for Methamphetamine are toxicity to various agents, cardiac arrest, respiratory arrest, cardio-respiratory arrest, drug toxicity, pulmonary oedema. 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 Methamphetamine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Methamphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methamphetamine, can result.

Do FAERS signals prove that Methamphetamine 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 90c02ac6-e5e2-4c97-8c68-81e4e389a195, effective 20240930; matched on openfda.generic_name.exact:"METHAMPHETAMINE HYDROCHLORIDE")
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, 40 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.