ATOMOXETINE

N/A

Manufactured by Aurobindo Pharma Limited

30,444 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ATOMOXETINE

ATOMOXETINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. The most commonly reported adverse reactions for ATOMOXETINE include DRUG INEFFECTIVE, OFF LABEL USE, NAUSEA, DRUG INTOLERANCE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATOMOXETINE.

Top Adverse Reactions

DRUG INEFFECTIVE606 reports
OFF LABEL USE606 reports
NAUSEA431 reports
DRUG INTOLERANCE407 reports
HEADACHE407 reports
FATIGUE401 reports
CONDITION AGGRAVATED395 reports
HYPERTENSION388 reports
INSOMNIA381 reports
VOMITING381 reports
PAIN379 reports
ARTHRALGIA374 reports
ABDOMINAL DISCOMFORT367 reports
HEPATIC ENZYME INCREASED367 reports
HYPOAESTHESIA360 reports
ABDOMINAL PAIN UPPER350 reports
ALOPECIA350 reports
GENERAL PHYSICAL HEALTH DETERIORATION350 reports
GLOSSODYNIA346 reports
DEPRESSION343 reports
PARAESTHESIA343 reports
DIZZINESS342 reports
BLOOD CHOLESTEROL INCREASED340 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE338 reports
MATERNAL EXPOSURE DURING PREGNANCY338 reports
JOINT SWELLING336 reports
ARTHROPATHY334 reports
HAND DEFORMITY333 reports
NAIL DISORDER327 reports
EPILEPSY321 reports
BLEPHAROSPASM319 reports
CONFUSIONAL STATE319 reports
GASTROOESOPHAGEAL REFLUX DISEASE319 reports
ASTHENIA311 reports
GASTROINTESTINAL DISORDER308 reports
PRODUCT USE IN UNAPPROVED INDICATION306 reports
MEMORY IMPAIRMENT305 reports
RASH301 reports
TASTE DISORDER300 reports
TREATMENT FAILURE299 reports
WEIGHT INCREASED298 reports
HELICOBACTER INFECTION295 reports
INFUSION RELATED REACTION295 reports
DIARRHOEA291 reports
PEMPHIGUS290 reports
PSORIATIC ARTHROPATHY288 reports
HYPERSENSITIVITY282 reports
LIVER INJURY282 reports
BURSITIS281 reports
MALAISE281 reports
FOLLICULITIS279 reports
PERIPHERAL SWELLING279 reports
DRY MOUTH278 reports
SLEEP DISORDER276 reports
SYNOVITIS276 reports
DRUG HYPERSENSITIVITY275 reports
TYPE 2 DIABETES MELLITUS275 reports
DYSPEPSIA274 reports
INFLAMMATION274 reports
IRRITABLE BOWEL SYNDROME274 reports
RHEUMATOID ARTHRITIS274 reports
OSTEOARTHRITIS272 reports
PERICARDITIS272 reports
SYSTEMIC LUPUS ERYTHEMATOSUS272 reports
C REACTIVE PROTEIN INCREASED270 reports
HYPERCHOLESTEROLAEMIA269 reports
DRUG INDUCED LIVER INJURY268 reports
GAIT INABILITY268 reports
PERIPHERAL VENOUS DISEASE268 reports
SWELLING268 reports
LIVE BIRTH267 reports
ONYCHOMADESIS267 reports
MUSCULOSKELETAL STIFFNESS266 reports
GRIP STRENGTH DECREASED265 reports
MOBILITY DECREASED265 reports
EXPOSURE DURING PREGNANCY264 reports
FIBROMYALGIA264 reports
CONTRAINDICATED PRODUCT ADMINISTERED262 reports
NASOPHARYNGITIS262 reports
BREAST CANCER STAGE III261 reports
MIGRAINE260 reports
URTICARIA260 reports
PNEUMONIA259 reports
BLISTER258 reports
IMPAIRED HEALING257 reports
STOMATITIS256 reports
ABDOMINAL DISTENSION255 reports
FACET JOINT SYNDROME255 reports
OBESITY253 reports
DUODENAL ULCER PERFORATION252 reports
MUSCLE SPASMS252 reports
WOUND250 reports
COELIAC DISEASE249 reports
LUNG DISORDER249 reports
INTENTIONAL PRODUCT USE ISSUE247 reports
NECK PAIN246 reports
LOWER RESPIRATORY TRACT INFECTION245 reports
PAIN IN EXTREMITY243 reports
NIGHT SWEATS242 reports
BACK INJURY241 reports

Report Outcomes

Out of 3,225 classified reports for ATOMOXETINE:

Serious 77.9%Non-Serious 22.1%

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

Female1,553 (57.4%)
Male1,064 (39.3%)
Unknown89 (3.3%)

Reports by Age

Age 40375 reports
Age 43226 reports
Age 1896 reports
Age 1269 reports
Age 958 reports
Age 1154 reports
Age 1454 reports
Age 1552 reports
Age 2649 reports
Age 1646 reports
Age 1045 reports
Age 2745 reports
Age 2943 reports
Age 2142 reports
Age 3241 reports
Age 1940 reports
Age 836 reports
Age 1736 reports
Age 3736 reports
Age 634 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 ATOMOXETINE?

This profile reflects 30,444 FDA FAERS reports that mention ATOMOXETINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ATOMOXETINE?

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

Who manufactures ATOMOXETINE?

Labeling and FAERS entries often list Aurobindo Pharma Limited in connection with ATOMOXETINE. 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.