Atomoxetine side effects: what 23,660 FDA adverse event reports show

Atomoxetine Hydrochloride · 1,126 reaction terms · 128,842 drug–reaction co-reports · data 2026-09-14

Drug class

Selective norepinephrine reuptake inhibitor

FDA label, Indications wording

Who reports

23,660 reports · 39% serious · 1,472 with death outcome · 42% 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 adverse reaction 3Labeled (related wording) 5Likely indication confounding 5Lab value / disease marker 4Not in label — unassessed 23

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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. 1,086 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
Hepatic enzyme	66	800.8 573.5–1,118.0ROR 803.0 · χ² 27,089 / p <1e-300	372.9 EB05 303.3 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=66 · ♀ 100% (drug 42%) · 100% clinician	not reported in cached trials
Semenuria	28	789.0 473.4–1,315.0ROR 789.9 · χ² 11,168 / p <1e-300	323.3 EB05 234.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	♀ 0% (drug 42%) · 100% consumer	not reported in cached trials
Growth hormone-producing pituitary tumour	14	679.4 338.0–1,365.9ROR 679.8 · χ² 4,960 / p <1e-300	251.5 EB05 159.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Fight in school	16	241.0 138.6–419.1ROR 241.1 · χ² 2,812 / p <1e-300	154.6 EB05 100.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Excitability	56	226.5 168.8–303.8ROR 227.0 · χ² 9,804 / p <1e-300	169.7 EB05 135.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	–	not reported in cached trials
Facet joint syndrome	503	168.4 153.2–185.1ROR 172.1 · χ² 70,050 / p <1e-300	140.6 EB05 130.6 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=503 · ♀ 100% (drug 42%) · 96% clinician	not reported in cached trials
Hypocholesterolaemia	46	155.7 113.8–213.1ROR 156.1 · χ² 5,872 / p <1e-300	125.5 EB05 97.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=46 · ♀ 100% (drug 42%) · 100% clinician	not reported in cached trials
Early morning awakening	17	135.0 81.0–225.0ROR 135.1 · χ² 1,844 / p <1e-300	103.7 EB05 68.6 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	–	not reported in cached trials
Oppositional defiant disorder	49	124.1 92.0–167.3ROR 124.3 · χ² 5,131 / p <1e-300	104.4 EB05 82.1 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 15% (drug 42%)	NCT00190684: 1/1,551 (0.1%) on Atomoxetine (serious AE)
Gilbert's syndrome	10	119.7 61.8–231.7ROR 119.7 · χ² 933 / p 3e-205	88.2 EB05 51.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=8	not reported in cached trials
Overlap syndrome	78	113.0 89.3–143.0ROR 113.4 · χ² 7,568 / p <1e-300	97.8 EB05 80.9 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=78 · ♀ 100% (drug 42%) · 100% clinician	not reported in cached trials
Blepharospasm	589	92.9 85.5–101.1ROR 95.3 · χ² 48,350 / p <1e-300	83.9 EB05 78.3 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=552 · ♀ 95% (drug 42%)	not reported in cached trials
Peripheral venous disease	373	91.3 82.1–101.5ROR 92.7 · χ² 30,083 / p <1e-300	82.4 EB05 75.6 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious n=373 · ♀ 100% (drug 42%) · 92% clinician	not reported in cached trials
Conduct disorder	18	83.2 51.3–134.9ROR 83.3 · χ² 1,261 / p 2e-276	70.6 EB05 47.2 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious n=9	NCT00190684: 1/1,551 (0.1%) on Atomoxetine (serious AE)
Penile discharge	24	83.2 54.7–126.4ROR 83.3 · χ² 1,705 / p <1e-300	71.9 EB05 50.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	♀ 0% (drug 42%)	not reported in cached trials
Swollen joint count	21	82.6 52.8–129.2ROR 82.7 · χ² 1,473 / p <1e-300	70.9 EB05 48.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=21 · ♀ 100% (drug 42%) · 100% clinician	not reported in cached trials
Onychomadesis	343	79.7 71.4–89.0ROR 80.9 · χ² 24,368 / p <1e-300	72.9 EB05 66.6 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=343 · ♀ 100% (drug 42%) · 95% clinician	not reported in cached trials
School refusal	14	77.9 45.1–134.5ROR 77.9 · χ² 906 / p 2e-199	65.5 EB05 41.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=8	not reported in cached trials
Rheumatic fever	346	76.2 68.3–85.0ROR 77.3 · χ² 23,556 / p <1e-300	69.9 EB05 63.9 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=346 · ♀ 100% (drug 42%) · 93% clinician	not reported in cached trials
Attention-seeking behaviour	12	72.8 40.4–131.2ROR 72.8 · χ² 719 / p 9e-159	61.1 EB05 37.2 · IC025 +3.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=6	not reported in cached trials
Breast cancer stage iii	471	70.0 63.8–76.8ROR 71.4 · χ² 29,592 / p <1e-300	64.7 EB05 59.9 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=471 · ♀ 100% (drug 42%) · 96% clinician	not reported in cached trials
Tic	386	67.4 60.8–74.7ROR 68.5 · χ² 23,376 / p <1e-300	62.4 EB05 57.4 · IC025 +5.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=83 · ♀ 18% (drug 42%)	not reported in cached trials
Urinary hesitation	162	64.1 54.7–75.2ROR 64.6 · χ² 9,324 / p <1e-300	59.4 EB05 52.1 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=16 · ♀ 14% (drug 42%)	NCT00700427: 1/180 (0.6%) on Atomoxetine
Duodenal ulcer perforation	486	62.8 57.3–68.8ROR 64.1 · χ² 27,527 / p <1e-300	58.5 EB05 54.3 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 85.8 · ♀ 100% (drug 42%) · 95% clinician	not reported in cached trials
Onychomycosis	274	59.1 52.3–66.8ROR 59.8 · χ² 14,610 / p <1e-300	55.2 EB05 50.0 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=274 · ♀ 100% (drug 42%) · 93% clinician	not reported in cached trials
Adulterated product	12	58.9 32.8–105.6ROR 58.9 · χ² 587 / p 7e-130	51.0 EB05 31.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Lupus vulgaris	73	57.9 45.7–73.3ROR 58.0 · χ² 3,773 / p <1e-300	53.6 EB05 44.1 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=73 · ♀ 100% (drug 42%) · 95% clinician	not reported in cached trials
Painful ejaculation	14	57.7 33.6–99.1ROR 57.7 · χ² 679 / p 5e-150	50.7 EB05 32.1 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	–	not reported in cached trials
Feeling hot and cold	18	57.2 35.5–92.1ROR 57.2 · χ² 880 / p 9e-194	51.0 EB05 34.1 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	–	not reported in cached trials
Subcutaneous drug absorption impaired	33	57.1 40.1–81.2ROR 57.2 · χ² 1,655 / p <1e-300	52.1 EB05 38.8 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=33 · ♀ 100% (drug 42%)	not reported in cached trials
Deep vein thrombosis postoperative	118	56.7 47.1–68.3ROR 57.0 · χ² 6,011 / p <1e-300	52.9 EB05 45.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=118 · ♀ 100% (drug 42%)	not reported in cached trials
Prescribed overdose	1,129	54.9 51.7–58.2ROR 57.6 · χ² 56,195 / p <1e-300	51.7 EB05 49.2 · IC025 +5.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 26.6	not reported in cached trials
Educational problem	97	54.4 44.3–66.7ROR 54.6 · χ² 4,733 / p <1e-300	50.7 EB05 42.8 · IC025 +5.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=21	not reported in cached trials
Negativism	43	53.0 39.0–72.1ROR 53.1 · χ² 2,019 / p <1e-300	49.0 EB05 37.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=12 · ♀ 14% (drug 42%)	NCT00190684: 1/1,551 (0.1%) on Atomoxetine (serious AE)
C-reactive protein	51	52.7 39.8–69.9ROR 52.8 · χ² 2,392 / p <1e-300	48.9 EB05 38.7 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious n=51 · ♀ 100% (drug 42%) · 100% clinician	not reported in cached trials
Muscle injury	455	52.0 47.3–57.1ROR 53.0 · χ² 21,434 / p <1e-300	49.0 EB05 45.4 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 77.7 · ♀ 100% (drug 42%) · 96% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	378	49.8 44.9–55.1ROR 50.5 · χ² 17,044 / p <1e-300	47.0 EB05 43.2 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious PRR 69.2 · ♀ 100% (drug 42%) · 96% clinician	not reported in cached trials
Urine amphetamine positive	17	47.8 29.3–77.8ROR 47.8 · χ² 694 / p 3e-153	43.3 EB05 28.6 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	–	not reported in cached trials
Lip dry	452	47.1 42.8–51.7ROR 47.9 · χ² 19,296 / p <1e-300	44.6 EB05 41.3 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=444 · ♀ 98% (drug 42%) · 95% clinician	not reported in cached trials
X-ray abnormal	90	47.0 38.0–58.1ROR 47.2 · χ² 3,803 / p <1e-300	44.3 EB05 37.1 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=90 · ♀ 100% (drug 42%) · 100% clinician	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Atomoxetine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).

NCT00700427 — A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) (N=2017, PHASE3; 130 AE terms posted; arms: Atomoxetine (Study Periods 2 and 3A); Atomoxetine (Study Period 3B); Placebo (Study Period 3B); Atomoxetine (Study Period 4; Open-Label )
NCT00190684 — Long-Term, Open Label Atomoxetine Study (N=1553, PHASE3; 130 AE terms posted; arms: Atomoxetine)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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)	2,406	1.6 1.6–1.7ROR 1.7 · χ² 608 / p 1e-134	1.6 EB05 1.6 · IC025 +0.6	Reporting / coding artifact	serious PRR 2.6	not reported in cached trials
Fatigue (tiredness)	1,882	2.1 2.1–2.2ROR 2.2 · χ² 1,198 / p 9e-263	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.5	NCT00700427: 4/180 (2.2%) on Atomoxetine; 3/258 (1.2%) control
Nausea	1,873	2.1 2.0–2.2ROR 2.2 · χ² 1,128 / p 2e-247	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.6	NCT00700427: 9/180 (5.0%) on Atomoxetine; 3/258 (1.2%) control
Vomiting	1,500	2.8 2.7–3.0ROR 3.0 · χ² 1,823 / p <1e-300	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.5	NCT00700427: 1/180 (0.6%) on Atomoxetine; 3/258 (1.2%) control
Headache	1,471	2.1 2.0–2.2ROR 2.2 · χ² 853 / p 1e-187	2.1 EB05 2.0 · IC025 +1.0	Labeled adverse reaction exact term	serious PRR 3.3	NCT00700427: 1/2,011 (0.0%) on Atomoxetine (serious AE)
Dizziness	1,396	2.5 2.4–2.6ROR 2.6 · χ² 1,269 / p 3e-278	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7 · ♀ 64% (drug 42%)	NCT00700427: 3/180 (1.7%) on Atomoxetine; 2/258 (0.8%) control
Somnolence (drowsiness)	1,360	6.0 5.7–6.4ROR 6.3 · χ² 5,717 / p <1e-300	6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.1	NCT00700427: 1/180 (0.6%) on Atomoxetine; 1/258 (0.4%) control
Insomnia (trouble sleeping)	1,261	4.2 4.0–4.4ROR 4.4 · χ² 3,102 / p <1e-300	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.4	NCT00700427: 1/180 (0.6%) on Atomoxetine (serious AE)
Off label use (used outside approved label)	1,259	1.3 1.2–1.4ROR 1.3 · χ² 83 / p 4e-20	1.3 EB05 1.2 · IC025 +0.3	Reporting / coding artifact	serious PRR 2.7 · ♀ 73% (drug 42%)	not reported in cached trials
Feeling abnormal	1,184	4.4 4.1–4.6ROR 4.6 · χ² 3,104 / p <1e-300	4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.6 · 71% consumer	not reported in cached trials
Depression	1,164	4.5 4.3–4.8ROR 4.7 · χ² 3,220 / p <1e-300	4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 6.4 · ♀ 64% (drug 42%)	NCT00700427: 1/180 (0.6%) on Atomoxetine; 3/258 (1.2%) control
Abdominal pain upper	1,147	5.0 4.7–5.3ROR 5.2 · χ² 3,649 / p <1e-300	4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3 · ♀ 66% (drug 42%)	NCT00700427: 38/2,011 (1.9%) on Atomoxetine
Prescribed overdose	1,129	54.9 51.7–58.2ROR 57.6 · χ² 56,195 / p <1e-300	51.7 EB05 49.2 · IC025 +5.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 26.6	not reported in cached trials
Anxiety	1,042	3.2 3.1–3.4ROR 3.3 · χ² 1,633 / p <1e-300	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.2	NCT00700427: 2/180 (1.1%) on Atomoxetine; 3/258 (1.2%) control
Suicidal ideation (thoughts of suicide)	1,005	9.8 9.2–10.4ROR 10.2 · χ² 7,894 / p <1e-300	9.7 EB05 9.2 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 12.8	NCT00700427: 3/2,011 (0.1%) on Atomoxetine (serious AE)

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.

Semenuria — n=28, PRR 789.0
Excitability — n=56, PRR 226.5
Facet joint syndrome — n=503, PRR 168.4
Hypocholesterolaemia — n=46, PRR 155.7
Oppositional defiant disorder — n=49, PRR 124.1 (also seen in trial arm)
Overlap syndrome — n=78, PRR 113.0
Blepharospasm — n=589, PRR 92.9
Penile discharge — n=24, PRR 83.2
Swollen joint count — n=21, PRR 82.6
Onychomadesis — n=343, PRR 79.7

✓ 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 fatigue, nausea, vomiting, headache, dizziness, somnolence. 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, 1,126 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
ClinicalTrials.gov API v2 (query ATOMOXETINE, results-bearing studies sorted by enrollment)

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.