Drug · FAERS side-effect profile with label screen
Amphetamine side effects: what 2,175 FDA adverse event reports show
Drug class
Central Nervous System Stimulant
FDA label (Established Pharmacologic Class) · compare the class
Who reports
2,175 reports · 77% serious · 964 with death outcome · 44% 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 40 strongest signals
Labeled — boxed warning 1Labeled adverse reaction 7Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 6Outcome field, not a reaction 1Not in label — unassessed 20
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. 37 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 |
|---|---|---|---|---|---|---|
| Drug abuse | 461 | 53.4 49.2–57.9ROR 67.5 · χ² 23,624 / p <1e-300 | 53.0 EB05 49.1 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 40.0 · 100% clinician | no trial data cached |
| Toxicity to various agents | 608 | 35.1 32.8–37.5ROR 48.3 · χ² 20,166 / p <1e-300 | 34.9 EB05 32.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · 100% clinician | no trial data cached |
| Respiratory arrest | 87 | 30.2 24.6–37.2ROR 31.5 · χ² 2,427 / p <1e-300 | 30.0 EB05 25.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 100% clinician | no trial data cached |
| Cardio-respiratory arrest | 93 | 21.3 17.5–26.0ROR 22.3 · χ² 1,783 / p <1e-300 | 21.2 EB05 17.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · 100% clinician | no trial data cached |
| Completed suicide (death by suicide) | 176 | 20.2 17.5–23.3ROR 21.9 · χ² 3,200 / p <1e-300 | 20.1 EB05 17.8 · IC025 +4.0 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 15.0 · 100% clinician | no trial data cached |
| Drug toxicity | 26 | 18.2 12.4–26.6ROR 18.4 · χ² 405 / p 3e-90 | 17.9 EB05 12.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Cardiogenic shock | 23 | 15.6 10.4–23.4ROR 15.7 · χ² 299 / p 3e-67 | 15.1 EB05 10.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 24% (drug 44%) · 100% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 117 | 13.6 11.4–16.3ROR 14.3 · χ² 1,360 / p 5e-298 | 13.5 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 100% clinician | no trial data cached |
| Respiratory depression | 13 | 10.2 5.9–17.6ROR 10.3 · χ² 99 / p 1e-23 | 8.6 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Poisoning | 13 | 9.9 5.8–17.1ROR 10.0 · χ² 96 / p 7e-23 | 8.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Pulmonary congestion | 13 | 9.5 5.5–16.3ROR 9.5 · χ² 90 / p 1e-21 | 7.9 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Brain oedema | 12 | 9.2 5.2–16.1ROR 9.2 · χ² 79 / p 3e-19 | 7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 38 | 8.8 6.4–12.1ROR 8.9 · χ² 256 / p 8e-58 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.6 · ♀ 14% (drug 44%) · 100% clinician | no trial data cached |
| Aggression | 45 | 8.7 6.5–11.6ROR 8.8 · χ² 298 / p 6e-67 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 18% (drug 44%) | no trial data cached |
| Disseminated intravascular coagulation | 12 | 8.2 4.7–14.4ROR 8.2 · χ² 69 / p 5e-17 | 6.6 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Hepatitis c | 10 | 7.9 4.3–14.7ROR 7.9 · χ² 54 / p 1e-13 | 6.2 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Abnormal behaviour | 29 | 7.0 4.9–10.1ROR 7.1 · χ² 144 / p 2e-33 | 6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 10 | 6.1 3.3–11.4ROR 6.1 · χ² 38 / p 4e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Encephalopathy | 15 | 5.9 3.6–9.8ROR 5.9 · χ² 56 / p 3e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Mania | 10 | 5.9 3.2–10.9ROR 5.9 · χ² 36 / p 1e-9 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Pulmonary oedema | 27 | 5.8 4.0–8.5ROR 5.9 · χ² 103 / p 2e-24 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 11% (drug 44%) · 100% clinician | no trial data cached |
| Intentional drug misuse | 12 | 5.5 3.1–9.6ROR 5.5 · χ² 39 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Dystonia | 11 | 5.5 3.0–9.8ROR 5.5 · χ² 36 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Accidental overdose | 20 | 5.3 3.4–8.2ROR 5.3 · χ² 65 / p 3e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Unresponsive to stimuli | 14 | 5.2 3.1–8.8ROR 5.3 · χ² 44 / p 2e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.0 | no trial data cached |
| Metabolic acidosis | 16 | 4.9 3.0–7.9ROR 4.9 · χ² 46 / p 8e-12 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Irritability | 30 | 4.8 3.4–6.9ROR 4.9 · χ² 87 / p 6e-21 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 · 85% consumer | no trial data cached |
| Anger | 16 | 4.5 2.8–7.4ROR 4.6 · χ² 41 / p 8e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Coma | 22 | 4.5 2.9–6.7ROR 4.5 · χ² 56 / p 5e-14 | 4.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · 95% clinician | no trial data cached |
| Agitation | 31 | 4.1 2.9–5.8ROR 4.1 · χ² 69 / p 6e-17 | 3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Psychotic disorder | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 7e-7 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Sedation | 10 | 3.7 2.0–6.9ROR 3.7 · χ² 17 / p 2e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Disturbance in attention | 20 | 3.6 2.3–5.5ROR 3.6 · χ² 34 / p 2e-9 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.0 | no trial data cached |
| Suicide attempt | 20 | 3.2 2.1–4.9ROR 3.2 · χ² 28 / p 7e-8 | 3.0 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Emotional disorder | 10 | 3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4 | 2.8 EB05 1.7 · IC025 +0.4 | Labeled (related wording) related wording | serious PRR 1.3 | no trial data cached |
| Intentional product misuse | 27 | 3.0 2.1–4.4ROR 3.0 · χ² 34 / p 3e-9 | 2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 11% (drug 44%) | no trial data cached |
| Withdrawal syndrome | 13 | 3.0 1.7–5.1ROR 3.0 · χ² 15 / p 5e-5 | 2.8 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Exposure during pregnancy | 19 | 2.9 1.9–4.6ROR 3.0 · χ² 23 / p 1e-6 | 2.8 EB05 1.9 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 26 | 2.7 1.9–4.0ROR 2.8 · χ² 27 / p 1e-7 | 2.6 EB05 1.9 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 2.1 | no trial data cached |
| Overdose | 58 | 2.6 2.0–3.3ROR 2.6 · χ² 55 / p 5e-14 | 2.5 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 95% clinician | 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 | 35.1 32.8–37.5ROR 48.3 · χ² 20,166 / p <1e-300 | 34.9 EB05 32.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · 100% clinician | no trial data cached |
| Drug abuse | 461 | 53.4 49.2–57.9ROR 67.5 · χ² 23,624 / p <1e-300 | 53.0 EB05 49.1 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 40.0 · 100% clinician | no trial data cached |
| Completed suicide (death by suicide) | 176 | 20.2 17.5–23.3ROR 21.9 · χ² 3,200 / p <1e-300 | 20.1 EB05 17.8 · IC025 +4.0 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 15.0 · 100% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 117 | 13.6 11.4–16.3ROR 14.3 · χ² 1,360 / p 5e-298 | 13.5 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 100% clinician | no trial data cached |
| Cardio-respiratory arrest | 93 | 21.3 17.5–26.0ROR 22.3 · χ² 1,783 / p <1e-300 | 21.2 EB05 17.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · 100% clinician | no trial data cached |
| Respiratory arrest | 87 | 30.2 24.6–37.2ROR 31.5 · χ² 2,427 / p <1e-300 | 30.0 EB05 25.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 100% clinician | no trial data cached |
| Overdose | 58 | 2.6 2.0–3.3ROR 2.6 · χ² 55 / p 5e-14 | 2.5 EB05 2.0 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 95% clinician | no trial data cached |
| Aggression | 45 | 8.7 6.5–11.6ROR 8.8 · χ² 298 / p 6e-67 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 18% (drug 44%) | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 38 | 8.8 6.4–12.1ROR 8.9 · χ² 256 / p 8e-58 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.6 · ♀ 14% (drug 44%) · 100% clinician | no trial data cached |
| Agitation | 31 | 4.1 2.9–5.8ROR 4.1 · χ² 69 / p 6e-17 | 3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Irritability | 30 | 4.8 3.4–6.9ROR 4.9 · χ² 87 / p 6e-21 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 · 85% consumer | no trial data cached |
| Abnormal behaviour | 29 | 7.0 4.9–10.1ROR 7.1 · χ² 144 / p 2e-33 | 6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Intentional product misuse | 27 | 3.0 2.1–4.4ROR 3.0 · χ² 34 / p 3e-9 | 2.9 EB05 2.1 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 11% (drug 44%) | no trial data cached |
| Pulmonary oedema | 27 | 5.8 4.0–8.5ROR 5.9 · χ² 103 / p 2e-24 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 11% (drug 44%) · 100% clinician | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 26 | 2.7 1.9–4.0ROR 2.8 · χ² 27 / p 1e-7 | 2.6 EB05 1.9 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 2.1 | 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 35.1
- Respiratory arrest — n=87, PRR 30.2
- Cardio-respiratory arrest — n=93, PRR 21.3
- Drug toxicity — n=26, PRR 18.2
- Cardiogenic shock — n=23, PRR 15.6
- Cardiac arrest — n=117, PRR 13.6
- Abnormal behaviour — n=29, PRR 7.0
- Pulmonary oedema — n=27, PRR 5.8
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 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, aggression, rhabdomyolysis. 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, fieldpatient.drug.openfda.generic_name.exact, 77 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.