ATOMOXETINE HYDROCHLORIDE

N/A

Manufactured by Eli Lilly and Company

63,960 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ATOMOXETINE HYDROCHLORIDE

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

Top Adverse Reactions

DRUG INEFFECTIVE2,316 reports
NAUSEA1,799 reports
FATIGUE1,788 reports
VOMITING1,424 reports
HEADACHE1,389 reports
SOMNOLENCE1,354 reports
DIZZINESS1,308 reports
INSOMNIA1,221 reports
OFF LABEL USE1,177 reports
FEELING ABNORMAL1,176 reports
PRESCRIBED OVERDOSE1,101 reports
DEPRESSION1,088 reports
ABDOMINAL PAIN UPPER1,070 reports
ANXIETY1,008 reports
SUICIDAL IDEATION999 reports
ABNORMAL BEHAVIOUR957 reports
AGGRESSION942 reports
DECREASED APPETITE926 reports
WEIGHT INCREASED850 reports
PAIN832 reports
DISTURBANCE IN ATTENTION761 reports
DRY MOUTH731 reports
WEIGHT DECREASED721 reports
ASTHENIA703 reports
RASH695 reports
PARAESTHESIA680 reports
DYSPNOEA673 reports
CONFUSIONAL STATE669 reports
IRRITABILITY654 reports
CONDITION AGGRAVATED648 reports
MEMORY IMPAIRMENT640 reports
HYPOAESTHESIA611 reports
ABDOMINAL DISCOMFORT599 reports
MIGRAINE598 reports
HYPERTENSION588 reports
AGITATION583 reports
DIARRHOEA583 reports
ANGER574 reports
GASTROOESOPHAGEAL REFLUX DISEASE558 reports
EPILEPSY557 reports
ALOPECIA555 reports
MOOD SWINGS555 reports
MALAISE539 reports
CRYING531 reports
SLEEP DISORDER528 reports
CHEST PAIN526 reports
PSYCHOMOTOR HYPERACTIVITY520 reports
BLEPHAROSPASM518 reports
NASOPHARYNGITIS514 reports
ARTHRALGIA503 reports
PRODUCT USE IN UNAPPROVED INDICATION497 reports
RHEUMATOID ARTHRITIS496 reports
TYPE 2 DIABETES MELLITUS495 reports
MUSCLE SPASMS492 reports
SWELLING490 reports
HEART RATE INCREASED487 reports
PSORIATIC ARTHROPATHY484 reports
URTICARIA482 reports
MATERNAL EXPOSURE DURING PREGNANCY480 reports
DRUG INTOLERANCE478 reports
SYSTEMIC LUPUS ERYTHEMATOSUS478 reports
PERICARDITIS475 reports
HYPERHIDROSIS474 reports
ABDOMINAL PAIN468 reports
HEPATIC ENZYME INCREASED458 reports
PEMPHIGUS450 reports
DYSPEPSIA449 reports
INFUSION RELATED REACTION443 reports
C REACTIVE PROTEIN INCREASED435 reports
SYNOVITIS432 reports
TASTE DISORDER432 reports
WOUND431 reports
INTENTIONAL PRODUCT USE ISSUE417 reports
BLOOD CHOLESTEROL INCREASED415 reports
ARTHROPATHY402 reports
DUODENAL ULCER PERFORATION402 reports
DRUG HYPERSENSITIVITY401 reports
FIBROMYALGIA400 reports
PRODUCT QUALITY ISSUE396 reports
FACET JOINT SYNDROME395 reports
GENERAL PHYSICAL HEALTH DETERIORATION393 reports
BREAST CANCER STAGE III392 reports
HELICOBACTER INFECTION388 reports
TIC385 reports
TREMOR385 reports
FOLLICULITIS384 reports
LOWER RESPIRATORY TRACT INFECTION384 reports
GLOSSODYNIA380 reports
LIVER INJURY379 reports
BURSITIS378 reports
STOMATITIS378 reports
BLISTER377 reports
IMPAIRED HEALING376 reports
INFLAMMATION376 reports
WHEEZING375 reports
CONSTIPATION373 reports
HAND DEFORMITY373 reports
LIP DRY373 reports
IRRITABLE BOWEL SYNDROME372 reports
PYREXIA365 reports

Report Outcomes

Out of 23,244 classified reports for ATOMOXETINE HYDROCHLORIDE:

Serious 38.7%Non-Serious 61.3%

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

Male12,750 (58.1%)
Female9,056 (41.3%)
Unknown126 (0.6%)

Reports by Age

Age 121,070 reports
Age 8990 reports
Age 10912 reports
Age 9905 reports
Age 7829 reports
Age 11737 reports
Age 14694 reports
Age 13691 reports
Age 40606 reports
Age 6594 reports
Age 16585 reports
Age 43583 reports
Age 15561 reports
Age 17373 reports
Age 5288 reports
Age 18288 reports
Age 35229 reports
Age 20214 reports
Age 25201 reports
Age 45194 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 HYDROCHLORIDE?

This profile reflects 63,960 FDA FAERS reports that mention ATOMOXETINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ATOMOXETINE HYDROCHLORIDE?

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

Who manufactures ATOMOXETINE HYDROCHLORIDE?

Labeling and FAERS entries often list Eli Lilly and Company in connection with ATOMOXETINE HYDROCHLORIDE. 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.