AMPHETAMINE

N/A

Manufactured by Amneal Pharmaceuticals NY LLC

14,926 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AMPHETAMINE

AMPHETAMINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. The most commonly reported adverse reactions for AMPHETAMINE include TOXICITY TO VARIOUS AGENTS, DRUG ABUSE, COMPLETED SUICIDE, OVERDOSE, CARDIAC ARREST. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AMPHETAMINE.

Top Adverse Reactions

TOXICITY TO VARIOUS AGENTS2,100 reports
DRUG ABUSE1,661 reports
COMPLETED SUICIDE796 reports
OVERDOSE437 reports
CARDIAC ARREST387 reports
DEATH376 reports
CARDIO RESPIRATORY ARREST358 reports
DRUG INEFFECTIVE322 reports
RESPIRATORY ARREST299 reports
DRUG INTERACTION238 reports
FATIGUE226 reports
SUBSTANCE ABUSE205 reports
OFF LABEL USE200 reports
HEADACHE190 reports
NAUSEA190 reports
DRUG DEPENDENCE187 reports
SOMNOLENCE172 reports
ANXIETY162 reports
INTENTIONAL PRODUCT MISUSE156 reports
POISONING150 reports
AGGRESSION144 reports
PULMONARY OEDEMA139 reports
AGITATION135 reports
INTENTIONAL OVERDOSE131 reports
DEPRESSION125 reports
TACHYCARDIA125 reports
INSOMNIA124 reports
DIZZINESS118 reports
RHABDOMYOLYSIS117 reports
FALL113 reports
LOSS OF CONSCIOUSNESS112 reports
PAIN111 reports
VOMITING111 reports
BRAIN OEDEMA110 reports
ACCIDENTAL OVERDOSE106 reports
RESPIRATORY DEPRESSION99 reports
ACUTE KIDNEY INJURY97 reports
HYPERTENSION97 reports
SUICIDE ATTEMPT97 reports
DYSPNOEA95 reports
FEELING ABNORMAL94 reports
SEROTONIN SYNDROME94 reports
CONDITION AGGRAVATED90 reports
SUICIDAL IDEATION89 reports
HYPERHIDROSIS88 reports
ABNORMAL BEHAVIOUR87 reports
UNRESPONSIVE TO STIMULI87 reports
HYPOTENSION86 reports
SEIZURE85 reports
PRODUCT DOSE OMISSION ISSUE83 reports
IRRITABILITY80 reports
COMA79 reports
RASH78 reports
ASTHENIA77 reports
DIARRHOEA76 reports
DRUG DIVERSION76 reports
ROAD TRAFFIC ACCIDENT75 reports
DISTURBANCE IN ATTENTION73 reports
TREMOR73 reports
DEPRESSED LEVEL OF CONSCIOUSNESS71 reports
MEMORY IMPAIRMENT67 reports
ARTHRALGIA66 reports
WEIGHT DECREASED66 reports
INTENTIONAL PRODUCT USE ISSUE65 reports
PNEUMONIA65 reports
RENAL FAILURE62 reports
BACK PAIN60 reports
MALAISE60 reports
DECREASED APPETITE59 reports
DRUG USE DISORDER59 reports
CONFUSIONAL STATE58 reports
METABOLIC ACIDOSIS57 reports
FOETAL EXPOSURE DURING PREGNANCY56 reports
MIOSIS55 reports
MYDRIASIS55 reports
PSYCHOTIC DISORDER55 reports
WEIGHT INCREASED55 reports
WITHDRAWAL SYNDROME55 reports
HYPOAESTHESIA53 reports
MATERNAL EXPOSURE DURING PREGNANCY53 reports
PRODUCT SUBSTITUTION ISSUE53 reports
PYREXIA53 reports
PRURITUS52 reports
PULMONARY CONGESTION52 reports
CARDIOGENIC SHOCK51 reports
PAIN IN EXTREMITY51 reports
PALPITATIONS51 reports
SUSPECTED SUICIDE51 reports
PRODUCT USE ISSUE50 reports
DRUG SCREEN POSITIVE49 reports
INTENTIONAL DRUG MISUSE49 reports
SUBSTANCE USE DISORDER49 reports
ABDOMINAL PAIN UPPER48 reports
CHRONIC KIDNEY DISEASE48 reports
LETHARGY48 reports
ABDOMINAL PAIN47 reports
MYELOPATHY47 reports
GAIT DISTURBANCE46 reports
MUSCLE SPASMS46 reports
EXPOSURE DURING PREGNANCY45 reports

Report Outcomes

Out of 7,885 classified reports for AMPHETAMINE:

Serious 81.9%Non-Serious 18.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male3,774 (54.4%)
Female3,144 (45.3%)
Unknown25 (0.4%)

Reports by Age

Age 35198 reports
Age 32192 reports
Age 30190 reports
Age 31183 reports
Age 36181 reports
Age 21176 reports
Age 27176 reports
Age 28172 reports
Age 37172 reports
Age 33168 reports
Age 24156 reports
Age 40148 reports
Age 25141 reports
Age 34138 reports
Age 41135 reports
Age 39126 reports
Age 26124 reports
Age 44124 reports
Age 29122 reports
Age 38122 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with AMPHETAMINE?

This profile reflects 14,926 FDA FAERS reports that mention AMPHETAMINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AMPHETAMINE?

Frequently reported terms in FAERS include TOXICITY TO VARIOUS AGENTS, DRUG ABUSE, COMPLETED SUICIDE, OVERDOSE, CARDIAC ARREST, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AMPHETAMINE?

Labeling and FAERS entries often list Amneal Pharmaceuticals NY LLC in connection with AMPHETAMINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.