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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ATOMOXETINE\ATOMOXETINE: 150 Adverse Event Reports & Safety Profile

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150
Total FAERS Reports
92 (61.3%)
Deaths Reported
84
Hospitalizations
150
As Primary/Secondary Suspect
80
Life-Threatening
80
Disabilities

Active Ingredient: ATOMOXETINE\ATOMOXETINE HYDROCHLORIDE ·

First Report: 20170801 · Latest Report: 20240605

What Are the Most Common ATOMOXETINE\ATOMOXETINE Side Effects?

#1 Most Reported
Off label use
70 reports (46.7%)
#2 Most Reported
Hypertension
69 reports (46.0%)
#3 Most Reported
Drug intolerance
68 reports (45.3%)

All ATOMOXETINE\ATOMOXETINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 70 46.7% 62 63
Hypertension 69 46.0% 66 56
Drug intolerance 68 45.3% 61 51
General physical health deterioration 65 43.3% 65 53
Glossodynia 65 43.3% 65 53
Abdominal discomfort 64 42.7% 62 51
Blood cholesterol increased 64 42.7% 64 55
Hand deformity 64 42.7% 64 53
Joint swelling 64 42.7% 64 53
Arthralgia 63 42.0% 63 51
Nail disorder 63 42.0% 63 52
Hepatic enzyme increased 62 41.3% 62 52
Alopecia 61 40.7% 60 51
Anti-cyclic citrullinated peptide antibody positive 61 40.7% 61 51
Arthropathy 61 40.7% 61 52
Drug ineffective 56 37.3% 39 29
Headache 56 37.3% 50 50
Live birth 55 36.7% 55 47
Exposure during pregnancy 54 36.0% 54 54
Condition aggravated 53 35.3% 50 50

Who Reports ATOMOXETINE\ATOMOXETINE Side Effects? Age & Gender Data

Gender: 94.3% female, 5.7% male. Average age: 39.4 years. Most reports from: CA. View detailed demographics →

Is ATOMOXETINE\ATOMOXETINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 1 1 1
2021 3 0 0
2023 6 0 1
2024 5 0 0

View full timeline →

What Is ATOMOXETINE\ATOMOXETINE Used For?

IndicationReports
Migraine 94
Attention deficit hyperactivity disorder 17
Product used for unknown indication 13

ATOMOXETINE\ATOMOXETINE vs Alternatives: Which Is Safer?

ATOMOXETINE\ATOMOXETINE vs ATORVASTATIN ATOMOXETINE\ATOMOXETINE vs ATORVASTATIN\EZETIMIBE ATOMOXETINE\ATOMOXETINE vs ATOSIBAN ATOMOXETINE\ATOMOXETINE vs ATOVAQUONE ATOMOXETINE\ATOMOXETINE vs ATOVAQUONE\PROGUANIL ATOMOXETINE\ATOMOXETINE vs ATRACURIUM ATOMOXETINE\ATOMOXETINE vs ATRIPLA ATOMOXETINE\ATOMOXETINE vs ATROPINE ATOMOXETINE\ATOMOXETINE vs ATROPINE\ATROPINE ATOMOXETINE\ATOMOXETINE vs ATROPINE\DIPHENOXYLATE

Official FDA Label for ATOMOXETINE\ATOMOXETINE

Official prescribing information from the FDA-approved drug label.