DEXTROAMPHETAMINE SULFATE

N/A

Manufactured by Amneal Pharmaceuticals LLC

8,480 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DEXTROAMPHETAMINE SULFATE

DEXTROAMPHETAMINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for DEXTROAMPHETAMINE SULFATE include DRUG INEFFECTIVE, FATIGUE, NAUSEA, ANXIETY, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROAMPHETAMINE SULFATE.

Top Adverse Reactions

DRUG INEFFECTIVE644 reports
FATIGUE295 reports
NAUSEA259 reports
ANXIETY257 reports
HEADACHE231 reports
DEPRESSION221 reports
FEELING ABNORMAL197 reports
INSOMNIA195 reports
SOMNOLENCE192 reports
WEIGHT DECREASED159 reports
PAIN152 reports
OFF LABEL USE147 reports
DIZZINESS145 reports
PRODUCT DOSE OMISSION ISSUE145 reports
CONDITION AGGRAVATED121 reports
DIARRHOEA116 reports
DISTURBANCE IN ATTENTION106 reports
HYPERTENSION106 reports
MIGRAINE104 reports
WEIGHT INCREASED104 reports
VOMITING103 reports
PRODUCT AVAILABILITY ISSUE102 reports
ASTHENIA101 reports
DYSPNOEA101 reports
MALAISE101 reports
FALL99 reports
SLEEP APNOEA SYNDROME94 reports
BLOOD PRESSURE INCREASED84 reports
PRE EXISTING CONDITION IMPROVED83 reports
SUICIDAL IDEATION81 reports
DRUG HYPERSENSITIVITY78 reports
TREMOR76 reports
THERAPEUTIC RESPONSE UNEXPECTED74 reports
INTENTIONAL PRODUCT USE ISSUE72 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS72 reports
PRODUCT SUBSTITUTION ISSUE71 reports
RASH70 reports
HYPERHIDROSIS69 reports
ARTHRITIS68 reports
DECREASED APPETITE68 reports
PNEUMONIA68 reports
PALPITATIONS66 reports
UNEVALUABLE EVENT66 reports
MUSCLE SPASMS65 reports
SURGERY64 reports
IRRITABILITY63 reports
PRODUCT ADMINISTRATION INTERRUPTED63 reports
HEART RATE INCREASED62 reports
CHEST PAIN59 reports
NASOPHARYNGITIS59 reports
PRURITUS59 reports
ARTHRALGIA58 reports
HYPOAESTHESIA58 reports
MEMORY IMPAIRMENT58 reports
DRY MOUTH57 reports
STRESS57 reports
THERAPEUTIC RESPONSE DECREASED57 reports
BACK PAIN54 reports
PARAESTHESIA54 reports
OVERDOSE53 reports
PRODUCT QUALITY ISSUE52 reports
ABDOMINAL DISCOMFORT51 reports
HYPERSENSITIVITY51 reports
SINUSITIS51 reports
ABDOMINAL PAIN UPPER49 reports
CONFUSIONAL STATE49 reports
GASTROOESOPHAGEAL REFLUX DISEASE49 reports
SLEEP DISORDER48 reports
VISION BLURRED48 reports
PRODUCT USE ISSUE47 reports
PYREXIA47 reports
AGITATION46 reports
COUGH46 reports
PAIN IN EXTREMITY46 reports
DRUG INTERACTION45 reports
PHARMACEUTICAL PRODUCT COMPLAINT44 reports
CONSTIPATION43 reports
COVID 1943 reports
PANIC ATTACK43 reports
URINARY TRACT INFECTION43 reports
ABDOMINAL PAIN41 reports
HYPERSOMNIA41 reports
AGGRESSION40 reports
GAIT DISTURBANCE40 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION40 reports
PSYCHOTIC DISORDER40 reports
SEIZURE40 reports
TOXICITY TO VARIOUS AGENTS40 reports
ALOPECIA39 reports
DEPRESSED MOOD39 reports
DRUG EFFECT DECREASED39 reports
LETHARGY39 reports
INTENTIONAL OVERDOSE38 reports
PERIPHERAL SWELLING38 reports
ROAD TRAFFIC ACCIDENT38 reports
TACHYCARDIA38 reports
COGNITIVE DISORDER37 reports
DRUG DEPENDENCE37 reports
ADVERSE EVENT36 reports
GASTROINTESTINAL DISORDER36 reports

Report Outcomes

Out of 3,979 classified reports for DEXTROAMPHETAMINE SULFATE:

Serious 51.6%Non-Serious 48.4%

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

Female2,356 (63.8%)
Male1,320 (35.7%)
Unknown17 (0.5%)

Reports by Age

Age 5447 reports
Age 5546 reports
Age 4343 reports
Age 5743 reports
Age 3042 reports
Age 5241 reports
Age 4040 reports
Age 5038 reports
Age 3437 reports
Age 4537 reports
Age 3836 reports
Age 4436 reports
Age 4636 reports
Age 4736 reports
Age 3135 reports
Age 4235 reports
Age 5335 reports
Age 5635 reports
Age 4134 reports
Age 3533 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 DEXTROAMPHETAMINE SULFATE?

This profile reflects 8,480 FDA FAERS reports that mention DEXTROAMPHETAMINE SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEXTROAMPHETAMINE SULFATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FATIGUE, NAUSEA, ANXIETY, HEADACHE, DEPRESSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DEXTROAMPHETAMINE SULFATE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with DEXTROAMPHETAMINE SULFATE. 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.