Atomoxetine side effects: what 3,549 FDA adverse event reports show

Atomoxetine · 323 reaction terms · 38,698 drug–reaction co-reports · data 2026-09-14

Drug class

Selective norepinephrine reuptake inhibitor

FDA label, Indications wording

Who reports

3,549 reports · 77% serious · 954 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

FDA label, Indications and Usage

What it is

Atomoxetine, USP is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochoride is the R (-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N -Methyl-3-phenyl-3-( o -tolyloxy)-propylamine hydrochloride.

FDA label, Description section

Boxed warning

SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 1Labeled (related wording) 4Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 30

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 283 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Helicobacter infection	307	183.3 164.4–204.4ROR 200.6 · χ² 53,814 / p <1e-300	175.8 EB05 159.9 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 140.3 · ♀ 95% (drug 60%) · 94% clinician	no trial data cached
Hypercholesterolaemia	286	181.9 162.5–203.7ROR 197.8 · χ² 49,748 / p <1e-300	174.4 EB05 158.1 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 140.1 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Folliculitis	291	171.1 153.0–191.4ROR 186.3 · χ² 47,675 / p <1e-300	164.5 EB05 149.2 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 146.0 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Hand deformity	341	158.0 142.6–175.0ROR 174.7 · χ² 51,668 / p <1e-300	152.5 EB05 139.4 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious PRR 125.0 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Coeliac disease	254	156.8 139.1–176.9ROR 168.8 · χ² 38,162 / p <1e-300	151.0 EB05 136.1 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 142.0 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Bursitis	293	146.9 131.5–164.2ROR 160.1 · χ² 41,304 / p <1e-300	142.0 EB05 128.9 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 126.0 · ♀ 100% (drug 60%) · 93% clinician	no trial data cached
Pemphigus	301	146.5 131.3–163.4ROR 159.9 · χ² 42,307 / p <1e-300	141.6 EB05 128.7 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 107.1 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Back injury	257	143.5 127.4–161.7ROR 154.7 · χ² 35,381 / p <1e-300	138.7 EB05 125.0 · IC025 +6.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 138.6 · ♀ 100% (drug 60%) · 96% clinician	no trial data cached
Wound infection	253	140.7 124.7–158.7ROR 151.4 · χ² 34,145 / p <1e-300	136.0 EB05 122.5 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 110.1 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Joint range of motion decreased	235	105.6 93.3–119.7ROR 113.1 · χ² 23,836 / p <1e-300	102.9 EB05 92.3 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 98.8 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Pericarditis	283	102.0 91.1–114.2ROR 110.7 · χ² 27,733 / p <1e-300	99.6 EB05 90.2 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 75.5 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Obesity	261	98.2 87.3–110.4ROR 105.9 · χ² 24,610 / p <1e-300	95.9 EB05 86.5 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 83.7 · ♀ 100% (drug 60%) · 93% clinician	no trial data cached
Adverse reaction	211	95.4 83.6–108.9ROR 101.4 · χ² 19,311 / p <1e-300	93.1 EB05 83.0 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious n=211 · ♀ 100% (drug 60%) · 96% clinician	no trial data cached
Synovitis	285	94.7 84.6–106.0ROR 102.9 · χ² 25,933 / p <1e-300	92.6 EB05 84.0 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 72.9 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Glossodynia (burning tongue/mouth pain)	353	94.7 85.7–104.7ROR 105.0 · χ² 32,146 / p <1e-300	92.7 EB05 84.9 · IC025 +6.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 100.8 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Taste disorder	308	92.1 82.7–102.6ROR 100.8 · χ² 27,272 / p <1e-300	90.2 EB05 82.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 136.1 · ♀ 100% (drug 60%) · 93% clinician	no trial data cached
Irritable bowel syndrome	286	80.1 71.6–89.6ROR 87.0 · χ² 21,977 / p <1e-300	78.6 EB05 71.3 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 74.9 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Liver injury	287	70.9 63.4–79.3ROR 77.0 · χ² 19,494 / p <1e-300	69.7 EB05 63.2 · IC025 +5.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 54.3 · ♀ 100% (drug 60%)	no trial data cached
Fibromyalgia	280	68.8 61.5–77.1ROR 74.7 · χ² 18,457 / p <1e-300	67.8 EB05 61.3 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 66.4 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Liver function test increased	241	67.5 59.7–76.3ROR 72.3 · χ² 15,550 / p <1e-300	66.4 EB05 59.6 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 77.8 · ♀ 98% (drug 60%) · 93% clinician	no trial data cached
Epilepsy	337	65.9 59.5–73.0ROR 72.7 · χ² 21,270 / p <1e-300	65.0 EB05 59.3 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 49.0 · ♀ 98% (drug 60%) · 93% clinician	no trial data cached
Wound	258	55.3 49.1–62.2ROR 59.5 · χ² 13,588 / p <1e-300	54.6 EB05 49.2 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 48.7 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Contraindicated product administered	272	53.7 47.9–60.2ROR 58.1 · χ² 13,910 / p <1e-300	53.0 EB05 48.0 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious PRR 49.0 · ♀ 96% (drug 60%) · 95% clinician	no trial data cached
Drug-induced liver injury	274	52.9 47.2–59.3ROR 57.2 · χ² 13,797 / p <1e-300	52.3 EB05 47.3 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 39.5 · ♀ 99% (drug 60%) · 95% clinician	no trial data cached
Gait inability	288	51.8 46.4–57.9ROR 56.3 · χ² 14,196 / p <1e-300	51.2 EB05 46.4 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 47.6 · ♀ 100% (drug 60%) · 91% clinician	no trial data cached
Type 2 diabetes mellitus	283	49.9 44.6–55.8ROR 54.1 · χ² 13,413 / p <1e-300	49.3 EB05 44.7 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 38.9 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Impaired healing	270	48.9 43.6–54.9ROR 52.9 · χ² 12,545 / p <1e-300	48.4 EB05 43.7 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious PRR 43.7 · ♀ 99% (drug 60%) · 93% clinician	no trial data cached
Systemic lupus erythematosus	282	47.4 42.4–53.1ROR 51.4 · χ² 12,689 / p <1e-300	46.9 EB05 42.5 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.1 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Night sweats	254	46.9 41.7–52.9ROR 50.5 · χ² 11,299 / p <1e-300	46.4 EB05 41.8 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 59.5 · ♀ 99% (drug 60%)	no trial data cached
C-reactive protein increased	280	45.8 40.9–51.3ROR 49.6 · χ² 12,150 / p <1e-300	45.3 EB05 41.0 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious PRR 35.3 · ♀ 99% (drug 60%) · 94% clinician	no trial data cached
Blood cholesterol increased	349	44.5 40.3–49.2ROR 49.2 · χ² 14,719 / p <1e-300	44.1 EB05 40.3 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious PRR 49.9 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached
Psoriatic arthropathy	300	44.4 39.8–49.5ROR 48.4 · χ² 12,600 / p <1e-300	43.9 EB05 39.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 41.1 · ♀ 99% (drug 60%) · 92% clinician	no trial data cached
Hepatitis (liver inflammation)	186	43.2 37.5–49.7ROR 45.5 · χ² 7,580 / p <1e-300	42.7 EB05 37.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 32.6 · ♀ 99% (drug 60%) · 91% clinician	no trial data cached
Osteoarthritis	283	39.6 35.4–44.3ROR 42.9 · χ² 10,557 / p <1e-300	39.2 EB05 35.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 33.0 · ♀ 100% (drug 60%) · 93% clinician	no trial data cached
Arthropathy	341	36.3 32.8–40.2ROR 40.1 · χ² 11,630 / p <1e-300	36.0 EB05 32.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 32.9 · ♀ 100% (drug 60%) · 95% clinician	no trial data cached
Inflammation	289	33.4 29.9–37.3ROR 36.3 · χ² 9,027 / p <1e-300	33.2 EB05 30.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 33.0 · ♀ 99% (drug 60%) · 92% clinician	no trial data cached
Lower respiratory tract infection	254	33.3 29.5–37.5ROR 35.8 · χ² 7,890 / p <1e-300	33.0 EB05 29.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.1 · ♀ 99% (drug 60%) · 93% clinician	no trial data cached
Hepatic enzyme increased	374	32.7 29.7–36.0ROR 36.4 · χ² 11,421 / p <1e-300	32.4 EB05 29.8 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 34.8 · ♀ 94% (drug 60%) · 94% clinician	no trial data cached
Autoimmune disorder	51	31.6 24.1–41.5ROR 32.1 · χ² 1,474 / p <1e-300	31.1 EB05 24.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 25.1 · ♀ 100% (drug 60%)	no trial data cached
Lung disorder	257	31.1 27.7–35.0ROR 33.5 · χ² 7,446 / p <1e-300	30.9 EB05 27.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.9 · ♀ 100% (drug 60%) · 94% clinician	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug ineffective (drug did not work)	639	2.9 2.7–3.1ROR 3.3 · χ² 826 / p 6e-182	2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7	no trial data cached
Off label use (used outside approved label)	635	4.3 4.0–4.6ROR 5.0 · χ² 1,687 / p <1e-300	4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8 · ♀ 83% (drug 60%)	no trial data cached
Nausea	450	3.4 3.1–3.7ROR 3.7 · χ² 776 / p 5e-171	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.4 · ♀ 85% (drug 60%)	no trial data cached
Headache	424	4.0 3.7–4.4ROR 4.4 · χ² 980 / p 3e-215	4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.7 · ♀ 83% (drug 60%)	no trial data cached
Fatigue (tiredness)	422	3.2 2.9–3.5ROR 3.5 · χ² 663 / p 1e-146	3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1 · ♀ 84% (drug 60%)	no trial data cached
Condition aggravated	421	8.2 7.5–9.0ROR 9.2 · χ² 2,706 / p <1e-300	8.2 EB05 7.5 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1 · ♀ 86% (drug 60%)	no trial data cached
Drug intolerance	415	25.6 23.3–28.0ROR 28.8 · χ² 9,772 / p <1e-300	25.4 EB05 23.4 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 30.6 · ♀ 96% (drug 60%) · 92% clinician	no trial data cached
Insomnia (trouble sleeping)	405	9.0 8.2–9.8ROR 10.0 · χ² 2,894 / p <1e-300	8.9 EB05 8.2 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.3	no trial data cached
Vomiting	404	5.1 4.6–5.6ROR 5.6 · χ² 1,353 / p 2e-296	5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4 · ♀ 85% (drug 60%)	no trial data cached
Hypertension (high blood pressure)	400	11.2 10.2–12.2ROR 12.4 · χ² 3,719 / p <1e-300	11.1 EB05 10.2 · IC025 +3.3 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 10.4 · ♀ 98% (drug 60%)	no trial data cached
Pain	390	3.7 3.4–4.1ROR 4.1 · χ² 805 / p 3e-177	3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.2 · ♀ 95% (drug 60%)	no trial data cached
Arthralgia (joint pain)	384	5.5 5.0–6.0ROR 6.0 · χ² 1,427 / p <1e-300	5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · ♀ 97% (drug 60%) · 91% clinician	no trial data cached
Hepatic enzyme increased	374	32.7 29.7–36.0ROR 36.4 · χ² 11,421 / p <1e-300	32.4 EB05 29.8 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 34.8 · ♀ 94% (drug 60%) · 94% clinician	no trial data cached
Abdominal discomfort	373	13.2 12.0–14.5ROR 14.6 · χ² 4,218 / p <1e-300	13.2 EB05 12.1 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.5 · ♀ 96% (drug 60%) · 92% clinician	no trial data cached
Hypoaesthesia (numbness)	373	14.7 13.4–16.2ROR 16.3 · χ² 4,782 / p <1e-300	14.7 EB05 13.5 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.5 · ♀ 98% (drug 60%) · 92% clinician	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Helicobacter infection — n=307, PRR 183.3
Hypercholesterolaemia — n=286, PRR 181.9
Folliculitis — n=291, PRR 171.1
Hand deformity — n=341, PRR 158.0
Coeliac disease — n=254, PRR 156.8
Bursitis — n=293, PRR 146.9
Pemphigus — n=301, PRR 146.5
Wound infection — n=253, PRR 140.7
Joint range of motion decreased — n=235, PRR 105.6
Pericarditis — n=283, PRR 102.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Atomoxetine ↔ Hypertension.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Atomoxetine?

In FDA FAERS, the most frequently co-reported reaction terms for Atomoxetine are nausea, headache, fatigue, insomnia, vomiting, hypertension. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Atomoxetine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need.

Do FAERS signals prove that Atomoxetine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 0782204e-56a3-4439-9fb8-194da9487049, effective 20231101; matched on openfda.generic_name.exact:"ATOMOXETINE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 323 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.