Amphetamine side effects: what 7,975 FDA adverse event reports show

Amphetamine · 1,009 reaction terms · 26,062 drug–reaction co-reports · data 2026-09-14

Drug class

Central Nervous System Stimulant

FDA label (Established Pharmacologic Class) · compare the class

Who reports

7,975 reports · 84% serious · 3,899 with death outcome · 45% 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 (related wording) 4Reporting / coding artifact 8Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 25

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 (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 969 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
Physical abuse	13	189.0 107.6–331.9ROR 189.3 · χ² 2,089 / p <1e-300	140.1 EB05 87.1 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious n=13	no trial data cached
Macular detachment	14	157.9 92.0–270.8ROR 158.1 · χ² 1,908 / p <1e-300	123.9 EB05 78.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Child neglect	10	125.1 66.3–236.0ROR 125.3 · χ² 1,057 / p 3e-232	97.6 EB05 56.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Coronary artery dissection	32	100.3 70.5–142.8ROR 100.7 · χ² 2,931 / p <1e-300	91.4 EB05 67.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 79% (drug 45%) · 100% clinician	no trial data cached
Decreased eye contact	10	87.0 46.3–163.4ROR 87.1 · χ² 741 / p 2e-163	72.9 EB05 42.3 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious n=10	no trial data cached
Oppositional defiant disorder	11	72.2 39.7–131.5ROR 72.3 · χ² 683 / p 6e-151	62.9 EB05 37.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Legal problem	20	71.2 45.7–111.0ROR 71.4 · χ² 1,279 / p 2e-280	65.2 EB05 44.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=20	no trial data cached
Substance abuse	210	67.4 58.8–77.1ROR 69.1 · χ² 13,312 / p <1e-300	65.3 EB05 58.2 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious PRR 51.2	no trial data cached
Myelopathy	48	65.9 49.5–87.7ROR 66.3 · χ² 2,928 / p <1e-300	62.7 EB05 49.2 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 0% (drug 45%) · 100% clinician	no trial data cached
Choroidal effusion	18	58.7 36.8–93.6ROR 58.8 · χ² 942 / p 3e-207	54.3 EB05 36.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=18	no trial data cached
Congestive hepatopathy	10	58.6 31.3–109.7ROR 58.7 · χ² 499 / p 1e-110	52.0 EB05 30.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Amphetamines positive	17	58.6 36.2–94.7ROR 58.7 · χ² 884 / p 1e-194	54.0 EB05 35.7 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=13	no trial data cached
Drug abuse	1,733	53.9 51.7–56.3ROR 68.0 · χ² 88,419 / p <1e-300	52.8 EB05 50.7 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious PRR 37.9	no trial data cached
Internal injury	12	47.4 26.8–83.8ROR 47.4 · χ² 490 / p 7e-109	43.5 EB05 26.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Substance use	28	47.2 32.5–68.5ROR 47.3 · χ² 1,197 / p 1e-262	45.0 EB05 32.7 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=25 · ♀ 21% (drug 45%) · 92% clinician	no trial data cached
Bladder dilatation	19	45.2 28.8–71.2ROR 45.3 · χ² 765 / p 1e-168	42.7 EB05 28.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=19	no trial data cached
Substance use disorder	53	44.7 34.1–58.6ROR 45.0 · χ² 2,181 / p <1e-300	43.3 EB05 34.4 · IC025 +4.5 3/3 methods agree	Labeled — boxed warning exact term	serious n=53 · 92% clinician	no trial data cached
Accidental poisoning	23	44.1 29.2–66.6ROR 44.3 · χ² 911 / p 2e-200	42.0 EB05 29.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 14% (drug 45%) · 95% clinician	no trial data cached
Exposure via ingestion	43	43.7 32.3–59.0ROR 43.9 · χ² 1,721 / p <1e-300	42.2 EB05 32.6 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=43 · 100% clinician	no trial data cached
Homicide	29	41.6 28.8–60.0ROR 41.7 · χ² 1,091 / p 2e-239	39.9 EB05 29.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 21% (drug 45%) · 86% consumer	no trial data cached
Renal infarct	22	39.1 25.7–59.5ROR 39.2 · χ² 767 / p 5e-169	37.3 EB05 26.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=22 · ♀ 100% (drug 45%) · 100% clinician	no trial data cached
Drug diversion	83	37.5 30.2–46.5ROR 37.9 · χ² 2,869 / p <1e-300	36.7 EB05 30.5 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=73 · 79% consumer	no trial data cached
Quadriparesis	24	37.4 25.0–55.9ROR 37.5 · χ² 802 / p 9e-177	35.9 EB05 25.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 17% (drug 45%) · 100% clinician	no trial data cached
Intestinal infarction	13	36.8 21.3–63.6ROR 36.9 · χ² 412 / p 8e-92	34.6 EB05 21.5 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious n=13	no trial data cached
Toxicity to various agents	2,183	33.6 32.4–34.8ROR 45.4 · χ² 68,625 / p <1e-300	33.1 EB05 32.0 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 24.0 · 93% clinician	no trial data cached
Suspected suicide	60	32.5 25.2–41.9ROR 32.7 · χ² 1,776 / p <1e-300	31.8 EB05 25.6 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=60 · 95% clinician	no trial data cached
Poisoning	154	31.5 26.9–36.9ROR 32.1 · χ² 4,462 / p <1e-300	31.0 EB05 27.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 22.4 · 95% clinician	no trial data cached
Respiratory arrest	303	28.1 25.1–31.4ROR 29.1 · χ² 7,806 / p <1e-300	27.7 EB05 25.2 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.8 · 99% clinician	no trial data cached
Compartment syndrome	28	27.7 19.1–40.1ROR 27.8 · χ² 686 / p 2e-151	26.9 EB05 19.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 11% (drug 45%) · 100% clinician	no trial data cached
Completed suicide (death by suicide)	824	25.2 23.6–26.9ROR 27.9 · χ² 19,014 / p <1e-300	25.0 EB05 23.6 · IC025 +4.5 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 17.7 · 98% clinician	no trial data cached
Brain oedema	114	23.2 19.3–27.9ROR 23.5 · χ² 2,381 / p <1e-300	22.9 EB05 19.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 16.5 · ♀ 17% (drug 45%) · 96% clinician	no trial data cached
Cardio-respiratory arrest	358	21.9 19.7–24.2ROR 22.8 · χ² 7,059 / p <1e-300	21.7 EB05 19.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.4 · 99% clinician	no trial data cached
Product monitoring error	12	21.5 12.2–37.9ROR 21.5 · χ² 213 / p 2e-48	20.4 EB05 12.0 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=12	no trial data cached
Alcohol abuse	22	21.0 13.8–31.9ROR 21.0 · χ² 395 / p 3e-88	20.4 EB05 14.1 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=20	no trial data cached
Respiratory depression	100	21.0 17.2–25.5ROR 21.2 · χ² 1,866 / p <1e-300	20.7 EB05 17.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.2 · ♀ 17% (drug 45%) · 95% clinician	no trial data cached
Substance-induced psychotic disorder	18	20.9 13.2–33.2ROR 20.9 · χ² 319 / p 1e-71	20.3 EB05 13.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=18	no trial data cached
Alcohol poisoning	20	19.3 12.5–30.0ROR 19.4 · χ² 327 / p 2e-73	18.8 EB05 12.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=20	no trial data cached
Cluster headache	10	18.9 10.1–35.1ROR 18.9 · χ² 151 / p 6e-35	17.4 EB05 9.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=10	no trial data cached
Drug use disorder	60	18.6 14.4–24.0ROR 18.7 · χ² 975 / p 3e-214	18.4 EB05 14.8 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.6 · ♀ 23% (drug 45%) · 98% clinician	no trial data cached
Hypoxic-ischaemic encephalopathy	19	18.6 11.8–29.1ROR 18.6 · χ² 296 / p 1e-66	18.0 EB05 11.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=19	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	2,183	33.6 32.4–34.8ROR 45.4 · χ² 68,625 / p <1e-300	33.1 EB05 32.0 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 24.0 · 93% clinician	no trial data cached
Drug abuse	1,733	53.9 51.7–56.3ROR 68.0 · χ² 88,419 / p <1e-300	52.8 EB05 50.7 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious PRR 37.9	no trial data cached
Completed suicide (death by suicide)	824	25.2 23.6–26.9ROR 27.9 · χ² 19,014 / p <1e-300	25.0 EB05 23.6 · IC025 +4.5 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 17.7 · 98% clinician	no trial data cached
Overdose	456	5.4 4.9–5.9ROR 5.6 · χ² 1,633 / p <1e-300	5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7	no trial data cached
Cardiac arrest (heart stopping)	399	12.3 11.2–13.6ROR 12.9 · χ² 4,139 / p <1e-300	12.2 EB05 11.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 96% clinician	no trial data cached
Death	391	1.2 1.1–1.3ROR 1.2 · χ² 9 / p 0.002	1.2 EB05 1.1 · IC025 +0.0	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 0.8	no trial data cached
Cardio-respiratory arrest	358	21.9 19.7–24.2ROR 22.8 · χ² 7,059 / p <1e-300	21.7 EB05 19.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.4 · 99% clinician	no trial data cached
Drug ineffective (drug did not work)	346	0.7 0.6–0.7ROR 0.7 · χ² 60 / p 5e-15	0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.5	no trial data cached
Respiratory arrest	303	28.1 25.1–31.4ROR 29.1 · χ² 7,806 / p <1e-300	27.7 EB05 25.2 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.8 · 99% clinician	no trial data cached
Fatigue (tiredness)	242	0.8 0.7–0.9ROR 0.8 · χ² 13 / p 1e-4	0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.6	no trial data cached
Drug interaction	240	3.9 3.4–4.4ROR 3.9 · χ² 509 / p 6e-113	3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0 · ♀ 23% (drug 45%) · 93% clinician	no trial data cached
Off label use (used outside approved label)	221	0.6 0.6–0.7ROR 0.6 · χ² 43 / p 2e-11	0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.5	no trial data cached
Substance abuse	210	67.4 58.8–77.1ROR 69.1 · χ² 13,312 / p <1e-300	65.3 EB05 58.2 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious PRR 51.2	no trial data cached
Drug dependence	203	3.2 2.8–3.6ROR 3.2 · χ² 304 / p 2e-68	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3	no trial data cached
Headache	199	0.8 0.7–0.9ROR 0.8 · χ² 9 / p 0.001	0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.6 · ♀ 69% (drug 45%)	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.

Coronary artery dissection — n=32, PRR 100.3
Legal problem — n=20, PRR 71.2
Myelopathy — n=48, PRR 65.9
Accidental poisoning — n=23, PRR 44.1
Homicide — n=29, PRR 41.6
Renal infarct — n=22, PRR 39.1
Quadriparesis — n=24, PRR 37.4
Toxicity to various agents — n=2,183, PRR 33.6
Poisoning — n=154, PRR 31.5
Respiratory arrest — n=303, PRR 28.1

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 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, fatigue, headache. 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, 1,009 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.