Amphetamine side effects: what 1,699 FDA adverse event reports show

Amphetamine Sulfate Tablets · 61 reaction terms · 2,220 drug–reaction co-reports · data 2026-09-14

Drug class

Central Nervous System Stimulant

FDA label (Established Pharmacologic Class) · compare the class

Who reports

1,699 reports · 89% serious · 960 with death outcome · 41% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Amphetamine extended-release orally disintegrating tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older . Limitat.

FDA label, Indications and Usage

What it is

Amphetamine extended-release orally disintegrating tablets contain a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphet.

FDA label, Description section

Boxed warning

ABUSE, MISUSE, AND ADDICTION Amphetamine extended-release orally disintegrating tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. .

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 34 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 3Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 8Outcome field, not a reaction 1Not in label — unassessed 19

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. 27 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	461	68.4 63.2–74.0ROR 93.5 · χ² 30,496 / p <1e-300	67.8 EB05 62.8 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 44.4 · 100% clinician	no trial data cached
Toxicity to various agents	608	44.9 42.1–47.8ROR 69.3 · χ² 26,150 / p <1e-300	44.7 EB05 41.8 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 29.5 · 100% clinician	no trial data cached
Respiratory arrest	87	38.7 31.5–47.5ROR 40.8 · χ² 3,154 / p <1e-300	38.3 EB05 32.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.1 · 100% clinician	no trial data cached
Cardio-respiratory arrest	93	27.3 22.4–33.3ROR 28.9 · χ² 2,332 / p <1e-300	27.1 EB05 22.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 17.7 · 100% clinician	no trial data cached
Completed suicide (death by suicide)	175	25.7 22.3–29.6ROR 28.6 · χ² 4,141 / p <1e-300	25.6 EB05 22.6 · IC025 +4.3 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 16.6 · 100% clinician	no trial data cached
Drug toxicity	26	23.3 15.9–34.1ROR 23.6 · χ² 531 / p 7e-118	22.9 EB05 16.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.6	no trial data cached
Cardiogenic shock	23	19.9 13.3–29.9ROR 20.2 · χ² 394 / p 5e-88	19.6 EB05 13.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 12.8 · 100% clinician	no trial data cached
Cardiac arrest (heart stopping)	117	17.5 14.6–20.8ROR 18.7 · χ² 1,803 / p <1e-300	17.4 EB05 14.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.3 · 100% clinician	no trial data cached
Respiratory depression	13	13.1 7.6–22.5ROR 13.2 · χ² 133 / p 4e-31	11.7 EB05 6.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Poisoning	13	12.7 7.4–21.9ROR 12.8 · χ² 129 / p 4e-30	11.3 EB05 6.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Pulmonary congestion	13	12.1 7.1–20.9ROR 12.2 · χ² 122 / p 1e-28	10.6 EB05 6.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Brain oedema	12	11.7 6.7–20.6ROR 11.8 · χ² 107 / p 2e-25	10.1 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Rhabdomyolysis (muscle breakdown)	38	11.3 8.2–15.4ROR 11.5 · χ² 346 / p 2e-77	10.8 EB05 8.0 · IC025 +2.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.3 · ♀ 14% (drug 41%) · 100% clinician	no trial data cached
Disseminated intravascular coagulation	12	10.5 6.0–18.4ROR 10.6 · χ² 94 / p 2e-22	8.7 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Hepatitis c	10	10.1 5.4–18.8ROR 10.2 · χ² 73 / p 6e-18	8.0 EB05 4.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Cyanosis (blue skin from low oxygen)	10	7.8 4.2–14.5ROR 7.9 · χ² 53 / p 2e-13	6.1 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Encephalopathy	15	7.6 4.6–12.5ROR 7.6 · χ² 79 / p 3e-19	6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Pulmonary oedema	27	7.4 5.1–10.8ROR 7.5 · χ² 144 / p 2e-33	6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.9 · ♀ 11% (drug 41%) · 100% clinician	no trial data cached
Aggression	30	7.4 5.2–10.5ROR 7.5 · χ² 160 / p 7e-37	6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4 · ♀ 21% (drug 41%)	no trial data cached
Intentional drug misuse	12	7.0 4.0–12.3ROR 7.0 · χ² 56 / p 4e-14	5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4	no trial data cached
Dystonia	11	7.0 3.9–12.6ROR 7.0 · χ² 51 / p 6e-13	5.6 EB05 3.3 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial data cached
Unresponsive to stimuli	14	6.7 4.0–11.3ROR 6.8 · χ² 63 / p 1e-15	5.6 EB05 3.5 · IC025 +1.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 4.4	no trial data cached
Abnormal behaviour	21	6.5 4.2–9.9ROR 6.6 · χ² 92 / p 3e-22	5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial data cached
Accidental overdose	19	6.4 4.1–10.0ROR 6.5 · χ² 82 / p 8e-20	5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.5	no trial data cached
Metabolic acidosis	16	6.2 3.8–10.2ROR 6.3 · χ² 65 / p 3e-16	5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Coma	22	5.7 3.8–8.6ROR 5.8 · χ² 81 / p 1e-19	5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7 · 95% clinician	no trial data cached
Psychotic disorder	11	4.6 2.6–8.3ROR 4.6 · χ² 27 / p 8e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Exposure during pregnancy	19	3.8 2.4–5.9ROR 3.8 · χ² 36 / p 9e-10	3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.5	no trial data cached
Suicide attempt	18	3.7 2.3–5.8ROR 3.7 · χ² 32 / p 7e-9	3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.4	no trial data cached
Intentional product misuse	24	3.4 2.3–5.1ROR 3.4 · χ² 39 / p 3e-10	3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.0 · ♀ 8% (drug 41%) · 100% clinician	no trial data cached
Intentional overdose	17	3.3 2.1–5.3ROR 3.3 · χ² 25 / p 3e-7	3.1 EB05 2.0 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2	no trial data cached
Overdose	56	3.2 2.5–4.1ROR 3.3 · χ² 83 / p 4e-20	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6 · 98% clinician	no trial data cached
Withdrawal syndrome	10	2.9 1.6–5.4ROR 2.9 · χ² 11 / p 5e-4	2.7 EB05 1.6 · IC025 +0.3	Not in label — unassessed	serious PRR 2.2	no trial data cached
Product substitution issue	13	2.8 1.6–4.8ROR 2.8 · χ² 13 / p 1e-4	2.6 EB05 1.6 · IC025 +0.4	Reporting / coding artifact	serious PRR 2.4	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
Toxicity to various agents	608	44.9 42.1–47.8ROR 69.3 · χ² 26,150 / p <1e-300	44.7 EB05 41.8 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 29.5 · 100% clinician	no trial data cached
Drug abuse	461	68.4 63.2–74.0ROR 93.5 · χ² 30,496 / p <1e-300	67.8 EB05 62.8 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 44.4 · 100% clinician	no trial data cached
Completed suicide (death by suicide)	175	25.7 22.3–29.6ROR 28.6 · χ² 4,141 / p <1e-300	25.6 EB05 22.6 · IC025 +4.3 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 16.6 · 100% clinician	no trial data cached
Cardiac arrest (heart stopping)	117	17.5 14.6–20.8ROR 18.7 · χ² 1,803 / p <1e-300	17.4 EB05 14.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.3 · 100% clinician	no trial data cached
Cardio-respiratory arrest	93	27.3 22.4–33.3ROR 28.9 · χ² 2,332 / p <1e-300	27.1 EB05 22.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 17.7 · 100% clinician	no trial data cached
Respiratory arrest	87	38.7 31.5–47.5ROR 40.8 · χ² 3,154 / p <1e-300	38.3 EB05 32.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.1 · 100% clinician	no trial data cached
Overdose	56	3.2 2.5–4.1ROR 3.3 · χ² 83 / p 4e-20	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6 · 98% clinician	no trial data cached
Rhabdomyolysis (muscle breakdown)	38	11.3 8.2–15.4ROR 11.5 · χ² 346 / p 2e-77	10.8 EB05 8.0 · IC025 +2.8 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.3 · ♀ 14% (drug 41%) · 100% clinician	no trial data cached
Aggression	30	7.4 5.2–10.5ROR 7.5 · χ² 160 / p 7e-37	6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4 · ♀ 21% (drug 41%)	no trial data cached
Pulmonary oedema	27	7.4 5.1–10.8ROR 7.5 · χ² 144 / p 2e-33	6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.9 · ♀ 11% (drug 41%) · 100% clinician	no trial data cached
Drug toxicity	26	23.3 15.9–34.1ROR 23.6 · χ² 531 / p 7e-118	22.9 EB05 16.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 15.6	no trial data cached
Intentional product misuse	24	3.4 2.3–5.1ROR 3.4 · χ² 39 / p 3e-10	3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.0 · ♀ 8% (drug 41%) · 100% clinician	no trial data cached
Cardiogenic shock	23	19.9 13.3–29.9ROR 20.2 · χ² 394 / p 5e-88	19.6 EB05 13.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 12.8 · 100% clinician	no trial data cached
Coma	22	5.7 3.8–8.6ROR 5.8 · χ² 81 / p 1e-19	5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7 · 95% clinician	no trial data cached
Abnormal behaviour	21	6.5 4.2–9.9ROR 6.6 · χ² 92 / p 3e-22	5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	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.

Toxicity to various agents — n=608, PRR 44.9
Respiratory arrest — n=87, PRR 38.7
Cardio-respiratory arrest — n=93, PRR 27.3
Drug toxicity — n=26, PRR 23.3
Cardiogenic shock — n=23, PRR 19.9
Cardiac arrest — n=117, PRR 17.5
Pulmonary oedema — n=27, PRR 7.4
Abnormal behaviour — n=21, PRR 6.5

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 Amphetamine?

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

Yes. The current FDA label carries a boxed warning: ABUSE, MISUSE, AND ADDICTION Amphetamine extended-release orally disintegrating tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. .

Do FAERS signals prove that Amphetamine 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 243e88e7-6621-47e9-8d5c-3f79bcb088bb, effective 20250901; matched on openfda.generic_name.exact:"AMPHETAMINE")
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, 61 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.