Drug · FAERS side-effect profile with label screen
Loxapine side effects: what 3,837 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,837 reports · 95% serious · 602 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
FDA label, Indications and Usage
What it is
DESCRIPTION Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines.
FDA label, Description section
Boxed warning
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen place.
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 adverse reaction 7Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 27
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 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.
- 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.
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. 127 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Poisoning deliberate | 206 | 122.9 107.5–140.6ROR 129.8 · χ² 24,246 / p <1e-300 | 118.9 EB05 105.9 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 73.3 · 100% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 156 | 72.2 61.8–84.2ROR 75.2 · χ² 10,739 / p <1e-300 | 70.6 EB05 61.8 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 43.1 · 97% clinician | no trial data cached |
| Euphoric mood | 125 | 66.7 56.0–79.3ROR 68.9 · χ² 7,925 / p <1e-300 | 65.2 EB05 56.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=125 · ♀ 2% (drug 44%) | no trial data cached |
| Akathisia (inner restlessness) | 162 | 65.2 56.0–75.9ROR 68.0 · χ² 10,063 / p <1e-300 | 64.0 EB05 56.1 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 52.6 · ♀ 9% (drug 44%) | no trial data cached |
| Leukaemia | 74 | 42.9 34.2–53.9ROR 43.8 · χ² 2,967 / p <1e-300 | 42.2 EB05 34.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · ♀ 0% (drug 44%) | no trial data cached |
| Hepatic cytolysis | 92 | 41.2 33.6–50.4ROR 42.2 · χ² 3,542 / p <1e-300 | 40.6 EB05 34.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.0 · 100% clinician | no trial data cached |
| Increased appetite | 125 | 36.3 30.6–43.2ROR 37.5 · χ² 4,236 / p <1e-300 | 35.9 EB05 30.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 56.8 · ♀ 0% (drug 44%) | no trial data cached |
| Poisoning | 79 | 34.2 27.5–42.6ROR 34.9 · χ² 2,499 / p <1e-300 | 33.7 EB05 27.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · 99% clinician | no trial data cached |
| Obesity | 88 | 30.1 24.5–37.0ROR 30.8 · χ² 2,435 / p <1e-300 | 29.8 EB05 24.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 5% (drug 44%) | no trial data cached |
| Coma | 262 | 30.0 26.7–33.7ROR 32.1 · χ² 7,292 / p <1e-300 | 29.8 EB05 26.9 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.3 · 99% clinician | no trial data cached |
| Parkinsonism | 51 | 28.5 21.7–37.5ROR 28.9 · χ² 1,321 / p 1e-289 | 28.1 EB05 22.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.7 · ♀ 19% (drug 44%) | no trial data cached |
| Altered state of consciousness | 107 | 27.1 22.5–32.7ROR 27.8 · χ² 2,652 / p <1e-300 | 26.8 EB05 22.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 97% clinician | no trial data cached |
| Hypothermia | 49 | 26.4 19.9–34.8ROR 26.7 · χ² 1,165 / p 1e-255 | 26.0 EB05 20.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · 96% clinician | no trial data cached |
| Sedation | 125 | 26.2 22.0–31.1ROR 27.0 · χ² 2,988 / p <1e-300 | 25.9 EB05 22.3 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.2 | no trial data cached |
| Extrapyramidal disorder | 112 | 24.3 20.3–29.2ROR 25.0 · χ² 2,476 / p <1e-300 | 24.2 EB05 20.6 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 | no trial data cached |
| Salivary hypersecretion | 43 | 23.5 17.4–31.6ROR 23.7 · χ² 899 / p 8e-198 | 23.2 EB05 17.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 | no trial data cached |
| Pneumonia aspiration | 86 | 18.8 15.2–23.2ROR 19.2 · χ² 1,428 / p <1e-300 | 18.7 EB05 15.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 91% clinician | no trial data cached |
| Prescribed overdose | 60 | 16.9 13.1–21.7ROR 17.1 · χ² 879 / p 2e-193 | 16.7 EB05 13.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · ♀ 4% (drug 44%) | no trial data cached |
| Suicide attempt | 177 | 15.9 13.7–18.3ROR 16.6 · χ² 2,449 / p <1e-300 | 15.8 EB05 13.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Choking | 56 | 15.7 12.1–20.4ROR 15.9 · χ² 755 / p 2e-166 | 15.5 EB05 12.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · 95% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 114 | 14.9 12.4–17.9ROR 15.3 · χ² 1,464 / p <1e-300 | 14.8 EB05 12.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 98% clinician | no trial data cached |
| Hepatocellular injury | 38 | 14.5 10.6–20.0ROR 14.7 · χ² 465 / p 2e-103 | 14.3 EB05 10.7 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · 97% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 41 | 13.6 10.1–18.5ROR 13.8 · χ² 467 / p 8e-104 | 13.3 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 90% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 90 | 13.6 11.1–16.7ROR 13.9 · χ² 1,038 / p 5e-228 | 13.5 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 91% clinician | no trial data cached |
| Respiratory depression | 30 | 13.3 9.3–19.0ROR 13.4 · χ² 329 / p 9e-74 | 12.9 EB05 9.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 70% (drug 44%) · 97% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 122 | 13.3 11.2–15.8ROR 13.7 · χ² 1,376 / p <1e-300 | 13.2 EB05 11.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · ♀ 6% (drug 44%) | no trial data cached |
| Intestinal obstruction | 87 | 12.6 10.3–15.6ROR 12.9 · χ² 920 / p 2e-202 | 12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 93% clinician | no trial data cached |
| Sinus tachycardia | 32 | 12.3 8.7–17.4ROR 12.4 · χ² 320 / p 7e-72 | 11.8 EB05 8.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Psychotic disorder | 66 | 12.2 9.6–15.4ROR 12.4 · χ² 664 / p 1e-146 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Hallucination, auditory | 35 | 12.0 8.6–16.6ROR 12.1 · χ² 340 / p 3e-76 | 11.5 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 38 | 11.8 8.6–16.3ROR 12.0 · χ² 366 / p 7e-82 | 11.4 EB05 8.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · ♀ 18% (drug 44%) | no trial data cached |
| Schizophrenia | 26 | 11.6 7.9–17.1ROR 11.7 · χ² 242 / p 8e-55 | 10.9 EB05 7.5 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.3 | no trial data cached |
| Drug resistance | 54 | 11.4 8.8–14.9ROR 11.6 · χ² 503 / p 8e-112 | 11.1 EB05 8.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · ♀ 22% (drug 44%) | no trial data cached |
| Myoclonus | 25 | 11.4 7.7–16.9ROR 11.5 · χ² 227 / p 2e-51 | 10.7 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Status epilepticus | 22 | 10.6 7.0–16.0ROR 10.6 · χ² 181 / p 1e-41 | 9.7 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 85% (drug 44%) · 95% clinician | no trial data cached |
| Myocarditis | 22 | 10.6 7.0–16.0ROR 10.6 · χ² 181 / p 2e-41 | 9.6 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 100% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 37 | 10.5 7.6–14.5ROR 10.6 · χ² 310 / p 1e-69 | 10.0 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 85% (drug 44%) · 97% clinician | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 19 | 10.2 6.5–15.9ROR 10.2 · χ² 148 / p 3e-34 | 9.0 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 53 | 10.1 7.7–13.2ROR 10.2 · χ² 426 / p 6e-95 | 9.7 EB05 7.6 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.0 | no trial data cached |
| Drug abuse | 154 | 10.0 8.6–11.7ROR 10.4 · χ² 1,243 / p 1e-272 | 9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 99% 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 |
|---|---|---|---|---|---|---|
| Coma | 262 | 30.0 26.7–33.7ROR 32.1 · χ² 7,292 / p <1e-300 | 29.8 EB05 26.9 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.3 · 99% clinician | no trial data cached |
| Somnolence (drowsiness) | 255 | 6.9 6.1–7.8ROR 7.3 · χ² 1,290 / p 9e-283 | 6.8 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Toxicity to various agents | 231 | 7.5 6.6–8.5ROR 7.9 · χ² 1,299 / p 8e-285 | 7.4 EB05 6.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 90% clinician | no trial data cached |
| Drug interaction | 217 | 7.4 6.5–8.5ROR 7.8 · χ² 1,210 / p 3e-265 | 7.3 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 93% clinician | no trial data cached |
| Weight increased (weight gain) | 209 | 5.1 4.5–5.8ROR 5.3 · χ² 691 / p 1e-152 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Poisoning deliberate | 206 | 122.9 107.5–140.6ROR 129.8 · χ² 24,246 / p <1e-300 | 118.9 EB05 105.9 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 73.3 · 100% clinician | no trial data cached |
| Suicide attempt | 177 | 15.9 13.7–18.3ROR 16.6 · χ² 2,449 / p <1e-300 | 15.8 EB05 13.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Akathisia (inner restlessness) | 162 | 65.2 56.0–75.9ROR 68.0 · χ² 10,063 / p <1e-300 | 64.0 EB05 56.1 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 52.6 · ♀ 9% (drug 44%) | no trial data cached |
| Neuroleptic malignant syndrome | 156 | 72.2 61.8–84.2ROR 75.2 · χ² 10,739 / p <1e-300 | 70.6 EB05 61.8 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 43.1 · 97% clinician | no trial data cached |
| Drug abuse | 154 | 10.0 8.6–11.7ROR 10.4 · χ² 1,243 / p 1e-272 | 9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 99% clinician | no trial data cached |
| Product use in unapproved indication | 149 | 3.3 2.8–3.9ROR 3.4 · χ² 241 / p 1e-54 | 3.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · ♀ 11% (drug 44%) | no trial data cached |
| Tachycardia (fast heart rate) | 139 | 8.5 7.2–10.0ROR 8.8 · χ² 916 / p 2e-201 | 8.3 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 97% clinician | no trial data cached |
| Hypotension (low blood pressure) | 137 | 3.7 3.2–4.4ROR 3.8 · χ² 272 / p 2e-61 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 98% clinician | no trial data cached |
| Therapeutic product effect incomplete | 126 | 9.7 8.2–11.5ROR 10.0 · χ² 975 / p 3e-214 | 9.5 EB05 8.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · ♀ 2% (drug 44%) | no trial data cached |
| Sedation | 125 | 26.2 22.0–31.1ROR 27.0 · χ² 2,988 / p <1e-300 | 25.9 EB05 22.3 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.2 | 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.
- Poisoning deliberate — n=206, PRR 122.9
- Euphoric mood — n=125, PRR 66.7
- Leukaemia — n=74, PRR 42.9
- Hepatic cytolysis — n=92, PRR 41.2
- Increased appetite — n=125, PRR 36.3
- Poisoning — n=79, PRR 34.2
- Obesity — n=88, PRR 30.1
- Parkinsonism — n=51, PRR 28.5
- Altered state of consciousness — n=107, PRR 27.1
- Hypothermia — n=49, PRR 26.4
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 Loxapine?
In FDA FAERS, the most frequently co-reported reaction terms for Loxapine are coma, somnolence, toxicity to various agents, weight increased, poisoning deliberate, suicide attempt. 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 Loxapine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen place.
Do FAERS signals prove that Loxapine 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 2d45dd3c-71c3-4cc1-92ac-6dcecb195dd2, effective 20260714; matched on
openfda.generic_name.exact:"LOXAPINE") - 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, fieldpatient.drug.openfda.generic_name.exact, 167 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.