Viloxazine side effects: what 79 FDA adverse event reports show

Viloxazine Hydrochloride · 44 reaction terms · 798 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

79 reports · 86% serious · 2 with death outcome · 35% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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 24 strongest signals

Reporting / coding artifact 5No label text to screen 19

What the badges mean

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.
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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 20 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
Mania	26	26.2 17.9–38.4ROR 26.8 · χ² 606 / p 4e-134	25.8 EB05 18.5 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Anger	44	21.5 16.1–28.7ROR 22.2 · χ² 839 / p 8e-185	21.3 EB05 16.5 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Withdrawal syndrome	54	21.2 16.3–27.5ROR 22.1 · χ² 1,020 / p 3e-224	21.0 EB05 16.7 · IC025 +3.7 3/3 methods agree	No label text to screen	–	no trial data cached
Migraine	121	21.2 17.9–25.1ROR 23.3 · χ² 2,310 / p <1e-300	21.1 EB05 18.1 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Initial insomnia	12	19.5 11.1–34.3ROR 19.7 · χ² 193 / p 5e-44	18.6 EB05 10.7 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Suicidal ideation (thoughts of suicide)	81	14.6 11.9–18.1ROR 15.6 · χ² 1,020 / p 4e-224	14.5 EB05 12.0 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial data cached
Insurance issue	11	12.3 6.8–22.1ROR 12.4 · χ² 103 / p 2e-24	10.5 EB05 5.5 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Irritability	42	11.6 8.6–15.6ROR 11.9 · χ² 395 / p 3e-88	11.2 EB05 8.4 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Product use complaint	10	10.7 5.8–19.8ROR 10.8 · χ² 78 / p 4e-19	8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Middle insomnia	12	10.7 6.1–18.8ROR 10.8 · χ² 96 / p 6e-23	8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Aggression	31	10.2 7.2–14.5ROR 10.5 · χ² 250 / p 1e-56	9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Impaired work ability	13	10.0 5.8–17.3ROR 10.1 · χ² 97 / p 3e-23	8.4 EB05 4.9 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Product dose omission in error	16	9.9 6.1–16.1ROR 10.0 · χ² 119 / p 5e-28	8.6 EB05 5.3 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Retching	12	9.3 5.3–16.4ROR 9.4 · χ² 81 / p 9e-20	7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Crying	19	8.6 5.5–13.5ROR 8.7 · χ² 121 / p 2e-28	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Nightmare	18	8.6 5.4–13.6ROR 8.7 · χ² 113 / p 1e-26	7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Mood swings	15	7.8 4.7–12.9ROR 7.9 · χ² 82 / p 6e-20	6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached
Therapy cessation	24	7.8 5.2–11.6ROR 7.9 · χ² 135 / p 1e-31	7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Panic attack	17	7.7 4.8–12.4ROR 7.8 · χ² 93 / p 3e-22	6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Emotional disorder	13	6.9 4.0–11.9ROR 7.0 · χ² 60 / p 4e-15	5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree	No label text to screen	–	no trial data cached
Adverse event	36	6.5 4.7–8.9ROR 6.6 · χ² 162 / p 2e-37	6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Abnormal behaviour	14	5.8 3.5–9.8ROR 5.9 · χ² 51 / p 4e-13	5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree	No label text to screen	–	no trial data cached
Therapy interrupted	24	5.8 3.9–8.6ROR 5.9 · χ² 90 / p 1e-21	5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug withdrawal syndrome	14	2.6 1.6–4.4ROR 2.6 · χ² 12 / p 2e-4	2.5 EB05 1.6 · IC025 +0.4	No label text to screen	–	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
Migraine	121	21.2 17.9–25.1ROR 23.3 · χ² 2,310 / p <1e-300	21.1 EB05 18.1 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Suicidal ideation (thoughts of suicide)	81	14.6 11.9–18.1ROR 15.6 · χ² 1,020 / p 4e-224	14.5 EB05 12.0 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial data cached
Withdrawal syndrome	54	21.2 16.3–27.5ROR 22.1 · χ² 1,020 / p 3e-224	21.0 EB05 16.7 · IC025 +3.7 3/3 methods agree	No label text to screen	–	no trial data cached
Anger	44	21.5 16.1–28.7ROR 22.2 · χ² 839 / p 8e-185	21.3 EB05 16.5 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Irritability	42	11.6 8.6–15.6ROR 11.9 · χ² 395 / p 3e-88	11.2 EB05 8.4 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Adverse event	36	6.5 4.7–8.9ROR 6.6 · χ² 162 / p 2e-37	6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Aggression	31	10.2 7.2–14.5ROR 10.5 · χ² 250 / p 1e-56	9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Mania	26	26.2 17.9–38.4ROR 26.8 · χ² 606 / p 4e-134	25.8 EB05 18.5 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Therapy interrupted	24	5.8 3.9–8.6ROR 5.9 · χ² 90 / p 1e-21	5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Therapy cessation	24	7.8 5.2–11.6ROR 7.9 · χ² 135 / p 1e-31	7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Crying	19	8.6 5.5–13.5ROR 8.7 · χ² 121 / p 2e-28	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Nightmare	18	8.6 5.4–13.6ROR 8.7 · χ² 113 / p 1e-26	7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Panic attack	17	7.7 4.8–12.4ROR 7.8 · χ² 93 / p 3e-22	6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree	No label text to screen	–	no trial data cached
Product dose omission in error	16	9.9 6.1–16.1ROR 10.0 · χ² 119 / p 5e-28	8.6 EB05 5.3 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Mood swings	15	7.8 4.7–12.9ROR 7.9 · χ² 82 / p 6e-20	6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree	No label text to screen	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Viloxazine?

In FDA FAERS, the most frequently co-reported reaction terms for Viloxazine are migraine, suicidal ideation, withdrawal syndrome, anger, irritability, aggression. 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 Viloxazine have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Viloxazine 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 44 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.