Drug · FAERS side-effect profile with label screen

Olanzapine and Samidorphan L-Malate side effects: what 1,575 FDA adverse event reports show

Olanzapine And Samidorphan L-Malate · 32 reaction terms · 604 drug–reaction co-reports · data 2026-09-14

Drug class

Atypical Antipsychotic

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Olanzapine (Olanzapine)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,575 reports · 23% serious · 16 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Olanzapine tablets are an atypical antipsychotic indicated: As oral formulation for the: • Treatment of schizophrenia. ( 1.1 ) o Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) o Adolescents (ages 13 to 17): Efficacy was established in one 6-‑ week trial in patients with schizophrenia ( 14.1 ).

FDA label, Indications and Usage

What it is

Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine.

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 16 strongest signals

Labeled adverse reaction 5Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 2Not in label — unassessed 6

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.
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. 16 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
Contraindicated product administered	108	47.6 39.7–57.2ROR 51.0 · χ² 4,872 / p <1e-300	47.1 EB05 40.1 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 84.0 · 92% clinician	no trial data cached
Sedation	54	27.5 21.2–35.8ROR 28.4 · χ² 1,352 / p 3e-296	27.2 EB05 21.7 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.1 · 91% clinician	no trial data cached
Euphoric mood	17	21.9 13.6–35.2ROR 22.1 · χ² 318 / p 2e-71	21.3 EB05 14.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Hypersomnia	43	19.9 14.8–26.8ROR 20.5 · χ² 755 / p 2e-166	19.7 EB05 15.2 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.9	no trial data cached
Mania	20	16.1 10.4–25.0ROR 16.3 · χ² 269 / p 9e-61	15.6 EB05 10.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Hallucination, auditory	16	13.3 8.2–21.7ROR 13.5 · χ² 170 / p 3e-39	12.3 EB05 7.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 17.2	no trial data cached
Psychotic disorder	29	13.0 9.1–18.7ROR 13.2 · χ² 310 / p 1e-69	12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 17.5	no trial data cached
Withdrawal syndrome	38	11.9 8.7–16.3ROR 12.2 · χ² 370 / p 8e-83	11.5 EB05 8.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.5 · 92% clinician	no trial data cached
Increased appetite	16	11.3 6.9–18.4ROR 11.4 · χ² 140 / p 1e-32	10.1 EB05 6.1 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.4	no trial data cached
Restlessness	21	7.6 5.0–11.6ROR 7.7 · χ² 114 / p 7e-27	6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.0	no trial data cached
Drug withdrawal syndrome	45	6.7 5.0–9.0ROR 6.9 · χ² 215 / p 7e-49	6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.5 · 93% clinician	no trial data cached
Muscle twitching	11	6.3 3.5–11.4ROR 6.3 · χ² 44 / p 2e-11	5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.6	no trial data cached
Therapeutic response unexpected	20	5.9 3.8–9.1ROR 6.0 · χ² 77 / p 1e-18	5.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.9	no trial data cached
Agitation	32	5.8 4.1–8.1ROR 5.9 · χ² 122 / p 1e-28	5.3 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3 · 94% clinician	no trial data cached
Nightmare	14	5.3 3.2–9.0ROR 5.4 · χ² 45 / p 9e-12	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 1.7	no trial data cached
Aggression	19	5.0 3.2–7.9ROR 5.1 · χ² 57 / p 2e-14	4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.2	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
Contraindicated product administered	108	47.6 39.7–57.2ROR 51.0 · χ² 4,872 / p <1e-300	47.1 EB05 40.1 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 84.0 · 92% clinician	no trial data cached
Sedation	54	27.5 21.2–35.8ROR 28.4 · χ² 1,352 / p 3e-296	27.2 EB05 21.7 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.1 · 91% clinician	no trial data cached
Drug withdrawal syndrome	45	6.7 5.0–9.0ROR 6.9 · χ² 215 / p 7e-49	6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.5 · 93% clinician	no trial data cached
Hypersomnia	43	19.9 14.8–26.8ROR 20.5 · χ² 755 / p 2e-166	19.7 EB05 15.2 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.9	no trial data cached
Withdrawal syndrome	38	11.9 8.7–16.3ROR 12.2 · χ² 370 / p 8e-83	11.5 EB05 8.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 18.5 · 92% clinician	no trial data cached
Agitation	32	5.8 4.1–8.1ROR 5.9 · χ² 122 / p 1e-28	5.3 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3 · 94% clinician	no trial data cached
Psychotic disorder	29	13.0 9.1–18.7ROR 13.2 · χ² 310 / p 1e-69	12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 17.5	no trial data cached
Restlessness	21	7.6 5.0–11.6ROR 7.7 · χ² 114 / p 7e-27	6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.0	no trial data cached
Therapeutic response unexpected	20	5.9 3.8–9.1ROR 6.0 · χ² 77 / p 1e-18	5.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.9	no trial data cached
Mania	20	16.1 10.4–25.0ROR 16.3 · χ² 269 / p 9e-61	15.6 EB05 10.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Aggression	19	5.0 3.2–7.9ROR 5.1 · χ² 57 / p 2e-14	4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.2	no trial data cached
Euphoric mood	17	21.9 13.6–35.2ROR 22.1 · χ² 318 / p 2e-71	21.3 EB05 14.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Increased appetite	16	11.3 6.9–18.4ROR 11.4 · χ² 140 / p 1e-32	10.1 EB05 6.1 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.4	no trial data cached
Hallucination, auditory	16	13.3 8.2–21.7ROR 13.5 · χ² 170 / p 3e-39	12.3 EB05 7.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 17.2	no trial data cached
Nightmare	14	5.3 3.2–9.0ROR 5.4 · χ² 45 / p 9e-12	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 1.7	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.

Mania — n=20, PRR 16.1
Withdrawal syndrome — n=38, PRR 11.9
Drug withdrawal syndrome — n=45, PRR 6.7

✓ A hand-written Bradford Hill causality assessment exists for this drug: Olanzapine (antipsychotics) ↔ Weight gain / metabolic syndrome.

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 Olanzapine and Samidorphan L-Malate?

In FDA FAERS, the most frequently co-reported reaction terms for Olanzapine and Samidorphan L-Malate are sedation, drug withdrawal syndrome, hypersomnia, withdrawal syndrome, agitation, psychotic disorder. 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 Olanzapine and Samidorphan L-Malate 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 Olanzapine and Samidorphan L-Malate 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 024e8e9b-a4fc-4882-b080-c070467166a6, effective 20240101; matched on openfda.generic_name.exact:"OLANZAPINE")
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, 32 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.