Drug · FAERS side-effect profile with label screen
Olanzapine side effects: what 106,808 FDA adverse event reports show
Who reports
106,808 reports · 86% serious · 13,180 with death outcome · 50% 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 a benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4.
PubChem CID 135398745 (ChEBI)
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 2Labeled adverse reaction 7Labeled (related wording) 11Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 14
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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,244 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 |
|---|---|---|---|---|---|---|
| Blood prolactin abnormal | 551 | 342.5 298.1–393.6ROR 344.3 · calibrated p 3e-12 ✓ | 123.4 EB05 115.0 · IC025 +6.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.0 (2.8–3.3) | Lab value / disease marker | serious n=544 · ♀ 76% (drug 50%) | not reported in cached trials |
| Anosognosia | 476 | 320.7 277.0–371.4ROR 322.2 · calibrated p 6e-12 ✓ | 120.4 EB05 111.6 · IC025 +6.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 2.9 (2.6–3.2) | Not in label — unassessed | serious n=469 · ♀ 78% (drug 50%) | not reported in cached trials |
| Diabetes mellitus non-insulin-dependent | 594 | 133.1 119.9–147.8ROR 133.8 · calibrated p 1e-8 ✓ | 78.9 EB05 73.8 · IC025 +6.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 17.9 (16.0–19.9) | Labeled (related wording) related wording | serious n=562 | not reported in cached trials |
| Total lung capacity increased | 104 | 120.7 94.5–154.3ROR 120.9 · calibrated p 4e-8 ✓ | 73.6 EB05 62.5 · IC025 +5.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 13.0 (10.2–16.7) | Not in label — unassessed | serious n=104 · ♀ 100% (drug 50%) · 100% clinician | not reported in cached trials |
| Post-injection delirium sedation syndrome | 318 | 114.3 99.5–131.3ROR 114.7 · calibrated p 5e-8 ✓ | 71.8 EB05 65.4 · IC025 +5.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 32.2 (27.0–38.4) | Not in label — unassessed | serious n=318 · ♀ 26% (drug 50%) | not reported in cached trials |
| Inspiratory capacity decreased | 98 | 108.5 84.7–139.0ROR 108.6 · calibrated p 9e-8 ✓ | 68.9 EB05 58.2 · IC025 +5.4 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Not in label — unassessed | serious n=98 · ♀ 0% (drug 50%) · 100% clinician | not reported in cached trials |
| Camptocormia | 75 | 89.8 68.3–118.1ROR 89.8 · calibrated p 4e-7 ✓ | 60.7 EB05 50.0 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Not in label — unassessed | serious n=73 · ♀ 100% (drug 50%) · 100% clinician | not reported in cached trials |
| Diabetes mellitus insulin-dependent | 159 | 89.3 74.0–107.8ROR 89.5 · calibrated p 3e-7 ✓ | 60.9 EB05 53.4 · IC025 +5.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 21.1 (16.9–26.3) | Labeled (related wording) related wording | serious n=158 · 100% consumer | not reported in cached trials |
| Central nervous system lupus | 65 | 84.1 62.8–112.5ROR 84.1 · calibrated p 7e-7 ✓ | 57.9 EB05 47.0 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Labeled (related wording) related wording | serious n=65 · ♀ 100% (drug 50%) · 100% consumer | not reported in cached trials |
| Schizoaffective disorder | 531 | 82.6 74.6–91.4ROR 83.0 · calibrated p 5e-7 ✓ | 58.0 EB05 54.0 · IC025 +5.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.9 (3.6–4.3) | Labeled adverse reaction exact term | serious n=526 · ♀ 70% (drug 50%) | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 202 | 80.4 68.3–94.8ROR 80.6 · calibrated p 6e-7 ✓ | 56.8 EB05 50.5 · IC025 +5.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.0 (2.6–3.5) | Lab value / disease marker | serious n=197 · ♀ 0% (drug 50%) | not reported in cached trials |
| Delusion of grandeur | 122 | 73.5 59.6–90.5ROR 73.6 · calibrated p 1e-6 ✓ | 53.1 EB05 45.6 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.0 (4.1–6.1) | Not in label — unassessed | serious n=121 · ♀ 0% (drug 50%) | not reported in cached trials |
| Metabolic syndrome | 407 | 64.6 57.7–72.2ROR 64.8 · calibrated p 3e-6 ✓ | 48.5 EB05 44.7 · IC025 +5.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.5 (6.7–8.4) | Labeled (related wording) related wording | serious n=375 | not reported in cached trials |
| Delusional disorder, persecutory type | 101 | 61.4 49.1–76.8ROR 61.5 · calibrated p 5e-6 ✓ | 46.4 EB05 39.3 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.6 (6.1–9.6) | Not in label — unassessed | serious n=101 · ♀ 0% (drug 50%) | not reported in cached trials |
| Neuroleptic malignant syndrome | 2,718 | 58.1 55.7–60.6ROR 59.6 · calibrated p 4e-6 ✓ | 44.9 EB05 43.5 · IC025 +5.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.7 (6.4–7.0) | Labeled — boxed warning exact term | age-adj. PRR 44.1 · serious PRR 30.1 | not reported in cached trials |
| Diabetic coma | 616 | 54.6 49.9–59.7ROR 54.9 · calibrated p 8e-6 ✓ | 42.7 EB05 39.9 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 11.8 (10.7–13.0) | Labeled adverse reaction exact term | serious n=615 | not reported in cached trials |
| Pleurothotonus | 198 | 54.4 46.4–63.6ROR 54.5 · calibrated p 9e-6 ✓ | 42.5 EB05 37.7 · IC025 +5.0 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.9 (5.9–8.1) | Not in label — unassessed | serious n=194 · ♀ 75% (drug 50%) · 100% clinician | not reported in cached trials |
| Metabolic disorder | 1,229 | 52.6 49.4–56.0ROR 53.2 · calibrated p 9e-6 ✓ | 41.5 EB05 39.6 · IC025 +5.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.5 (5.2–5.8) | Labeled (related wording) related wording | serious n=1,188 | not reported in cached trials |
| Disturbance in social behaviour | 476 | 49.3 44.6–54.5ROR 49.5 · calibrated p 1e-5 ✓ | 39.4 EB05 36.5 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 2.9 (2.6–3.2) | Reporting / coding artifact | serious n=471 · ♀ 77% (drug 50%) | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 104 | 48.9 39.4–60.6ROR 48.9 · calibrated p 2e-5 ✓ | 38.9 EB05 33.1 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 13.0 (10.2–16.7) | Labeled (related wording) related wording | serious n=104 · ♀ 100% (drug 50%) · 100% clinician | not reported in cached trials |
| Orthostatic hypertension | 113 | 46.8 38.1–57.5ROR 46.9 · calibrated p 2e-5 ✓ | 37.7 EB05 32.2 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.8 (4.7–7.2) | Labeled (related wording) related wording | serious n=114 · ♀ 100% (drug 50%) | not reported in cached trials |
| Schizophrenia | 2,234 | 44.1 42.1–46.1ROR 45.0 · calibrated p 3e-5 ✓ | 36.0 EB05 34.8 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.4 (3.3–3.5) | Labeled — boxed warning exact term | serious PRR 24.5 | NCT02717195: 1/384 (0.3%) on Olanzapine (serious AE) |
| Psychotic symptom | 371 | 43.5 38.9–48.7ROR 43.7 · calibrated p 3e-5 ✓ | 35.6 EB05 32.7 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.9 (3.5–4.4) | Likely indication confounding term in indications; also in warnings | serious n=366 | not reported in cached trials |
| Schizophrenia, paranoid type | 65 | 42.5 32.5–55.5ROR 42.5 · calibrated p 5e-5 ✓ | 34.7 EB05 28.1 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.6 (5.0–8.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=61 | not reported in cached trials |
| Obsessive-compulsive symptom | 64 | 41.3 31.5–54.0ROR 41.3 · calibrated p 6e-5 ✓ | 33.8 EB05 27.4 · IC025 +4.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 26.7 (18.4–38.7) | Not in label — unassessed | serious n=63 · ♀ 0% (drug 50%) · 100% clinician | not reported in cached trials |
| Disinhibition | 271 | 39.6 34.7–45.1ROR 39.7 · calibrated p 6e-5 ✓ | 32.9 EB05 29.8 · IC025 +4.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.3 (3.7–4.9) | Not in label — unassessed | serious n=269 · ♀ 13% (drug 50%) | not reported in cached trials |
| Catatonia | 874 | 39.4 36.7–42.4ROR 39.7 · calibrated p 6e-5 ✓ | 32.9 EB05 31.1 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.2 (5.8–6.7) | Not in label — unassessed | serious n=853 | not reported in cached trials |
| Oculogyric crisis | 347 | 38.6 34.4–43.3ROR 38.8 · calibrated p 7e-5 ✓ | 32.3 EB05 29.5 · IC025 +4.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.7 (3.3–4.1) | Labeled adverse reaction exact term | serious n=340 | not reported in cached trials |
| Sinus rhythm | 67 | 35.3 27.2–45.8ROR 35.3 · calibrated p 1e-4 ✓ | 29.7 EB05 24.2 · IC025 +4.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.4 (4.8–8.4) | Labeled (related wording) related wording | serious n=64 · ♀ 100% (drug 50%) · 100% clinician | not reported in cached trials |
| Anticholinergic syndrome | 236 | 34.0 29.6–39.1ROR 34.1 · calibrated p 1e-4 ✓ | 29.0 EB05 26.0 · IC025 +4.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 13.4 (11.4–15.8) | Labeled (related wording) related wording | serious n=236 · 92% clinician | not reported in cached trials |
| Cogwheel rigidity | 154 | 33.5 28.2–39.7ROR 33.5 · calibrated p 2e-4 ✓ | 28.6 EB05 25.0 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.2 (3.5–5.0) | Labeled adverse reaction exact term | serious n=148 | not reported in cached trials |
| Antipsychotic drug level above therapeutic | 130 | 33.1 27.5–39.9ROR 33.2 · calibrated p 2e-4 ✓ | 28.3 EB05 24.5 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.6 (3.0–4.4) | Lab value / disease marker | serious n=129 · 100% clinician | not reported in cached trials |
| Psychiatric decompensation | 260 | 30.1 26.4–34.3ROR 30.1 · calibrated p 3e-4 ✓ | 26.1 EB05 23.6 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.4 (3.0–3.8) | Not in label — unassessed | serious n=232 | not reported in cached trials |
| Negativism | 97 | 28.5 23.1–35.3ROR 28.6 · calibrated p 4e-4 ✓ | 24.9 EB05 21.0 · IC025 +4.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 35.4 (25.5–49.2) | Not in label — unassessed | serious n=93 | not reported in cached trials |
| Parkinsonism | 1,188 | 27.1 25.5–28.8ROR 27.4 · calibrated p 4e-4 ✓ | 23.9 EB05 22.8 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.7 (4.4–5.0) | Labeled adverse reaction exact term | serious PRR 17.7 | not reported in cached trials |
| Akathisia (inner restlessness) | 1,619 | 26.3 25.0–27.7ROR 26.7 · calibrated p 5e-4 ✓ | 23.3 EB05 22.3 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.2 (3.0–3.3) | Labeled adverse reaction exact term | serious PRR 20.3 | NCT03367572: 2/110 (1.8%) control |
| Hepatitis viral | 93 | 25.7 20.7–31.9ROR 25.7 · calibrated p 7e-4 ✓ | 22.7 EB05 19.1 · IC025 +4.0 3/3 methods agree vs other Atypical Antipsychotics: PRR 22.1 (16.5–29.6) | Labeled (related wording) related wording | serious n=93 · 100% consumer | not reported in cached trials |
| Persecutory delusion | 275 | 24.5 21.7–27.8ROR 24.6 · calibrated p 8e-4 ✓ | 21.9 EB05 19.8 · IC025 +4.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.0 (3.5–4.6) | Not in label — unassessed | serious n=271 | not reported in cached trials |
| Pressure of speech | 72 | 24.3 19.1–31.1ROR 24.4 · calibrated p 9e-4 ✓ | 21.6 EB05 17.7 · IC025 +3.9 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Labeled (related wording) related wording | serious n=70 · ♀ 100% (drug 50%) | not reported in cached trials |
| Glycosuria | 149 | 24.2 20.4–28.7ROR 24.2 · calibrated p 9e-4 ✓ | 21.6 EB05 18.8 · IC025 +4.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 14.0 (11.4–17.3) | Labeled adverse reaction exact term | serious n=143 · 100% consumer | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Extrapyramidal | 6,628 | 13.112.8–13.4 | signal |
| Suicidality | 8,584 | 7.16.9–7.2 | signal |
| Pancreatitis | 2,343 | 5.85.6–6.1 | signal |
| Rhabdomyolysis / myopathy | 2,326 | 5.85.5–6.0 | signal |
| Hyperglycaemia / diabetes | 9,158 | 5.35.2–5.4 | signal |
| Hyponatraemia | 1,798 | 4.54.3–4.7 | signal |
| Neutropenia / agranulocytosis | 4,647 | 3.73.6–3.8 | signal |
| Arrhythmia / qt | 3,231 | 3.33.2–3.4 | signal |
| Seizure | 2,553 | 2.62.5–2.7 | signal |
| Depression | 3,404 | 2.42.3–2.5 | signal |
| Liver injury | 3,209 | 2.12.0–2.2 | signal |
| Hypoglycaemia | 994 | 2.01.9–2.2 | raised |
| Venous thromboembolism | 2,099 | 1.91.8–2.0 | raised |
| Thrombocytopenia | 2,024 | 1.81.7–1.9 | raised |
| Severe cutaneous reaction | 643 | 1.71.6–1.8 | raised |
| Anaemia | 2,335 | 1.51.5–1.6 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Olanzapine 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 (2 of 40 signal terms matched).
- NCT03367572 — Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer (N=1363, PHASE3; 37 AE terms posted; arms: Group I (Netupitant/Palonosetron Hydroch; Group II (Net/Pal Hydro, Dexa, Prochlorp; Group III (Net/Pal Hydro, Dexa, Olanzapi)
- NCT02717195 — Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia (N=1098, PHASE3; 26 AE terms posted; arms: Prospective Confirmation (PC) Period, Ri; PC Period, Olanzapine; Double Blind Treatment (DBT) Period, Lu ; DBT Period, Lu AF35700 20 mg)
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) | 7,398 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.380 | 1.1 EB05 1.1 · IC025 +0.1 vs other Atypical Antipsychotics: PRR 4.3 (4.3–4.4) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.8 | not reported in cached trials |
| Weight increased (weight gain) | 6,832 | 6.2 6.0–6.3ROR 6.5 · calibrated p 0.119 | 6.0 EB05 5.9 · IC025 +2.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.4 (4.3–4.5) | Labeled adverse reaction exact term | age-adj. PRR 5.0 · serious PRR 6.3 | NCT02717195: 1/384 (0.3%) on Olanzapine |
| Off label use (used outside approved label) | 5,998 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.562 | 1.4 EB05 1.3 · IC025 +0.4 vs other Atypical Antipsychotics: PRR 3.4 (3.4–3.5) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.4 | not reported in cached trials |
| Diabetes mellitus | 5,404 | 14.8 14.4–15.2ROR 15.6 · calibrated p 0.006 ✓ | 13.9 EB05 13.5 · IC025 +3.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 9.1 (8.9–9.4) | Labeled adverse reaction exact term | age-adj. PRR 11.0 · serious PRR 9.1 | NCT02717195: 1/384 (0.3%) on Olanzapine (serious AE) |
| Toxicity to various agents | 4,189 | 5.0 4.9–5.2ROR 5.2 · calibrated p 0.217 | 4.9 EB05 4.8 · IC025 +2.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.3 (8.0–8.6) | Labeled (related wording) related wording | age-adj. PRR 4.0 · serious PRR 3.3 | not reported in cached trials |
| Drug interaction | 4,189 | 5.3 5.1–5.5ROR 5.5 · calibrated p 0.189 | 5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.8 (4.6–4.9) | Reporting / coding artifact | age-adj. PRR 4.4 · serious PRR 3.7 | not reported in cached trials |
| Nausea | 4,059 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.313 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Atypical Antipsychotics: PRR 6.0 (5.8–6.2) | Labeled adverse reaction exact term | age-adj. PRR 0.8 · serious PRR 1.0 | NCT03367572: 1/91 (1.1%) on Olanzapine (serious AE) |
| Somnolence (drowsiness) | 3,965 | 3.9 3.8–4.1ROR 4.0 · calibrated p 0.370 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.0 (4.8–5.1) | Labeled adverse reaction exact term | age-adj. PRR 3.8 · serious PRR 4.0 | NCT03367572: 1/110 (0.9%) control |
| Fatigue (tiredness) | 3,605 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.248 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Atypical Antipsychotics: PRR 5.0 (4.8–5.2) | Labeled adverse reaction exact term | age-adj. PRR 0.7 · serious PRR 0.9 | NCT03367572: 2/109 (1.8%) control (serious AE) |
| Overdose | 3,451 | 3.2 3.1–3.3ROR 3.2 · calibrated p 0.555 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.2 (6.9–7.4) | Reporting / coding artifact | age-adj. PRR 3.6 · serious PRR 2.5 | NCT02717195: 1/230 (0.4%) on Olanzapine (serious AE) |
| Anxiety | 3,449 | 2.4 2.3–2.5ROR 2.4 · calibrated p 0.840 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.2 (4.1–4.3) | Not in label — unassessed | age-adj. PRR 2.0 · serious PRR 2.0 | NCT03367572: 1/91 (1.1%) on Olanzapine |
| Vomiting | 3,301 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.573 | 1.4 EB05 1.3 · IC025 +0.4 vs other Atypical Antipsychotics: PRR 6.0 (5.8–6.2) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.2 | not reported in cached trials |
| Suicide attempt | 3,200 | 10.9 10.5–11.3ROR 11.2 · calibrated p 0.022 ✓ | 10.3 EB05 10.0 · IC025 +3.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.6 (4.4–4.8) | Labeled — boxed warning exact term | age-adj. PRR 8.3 · serious PRR 6.9 | NCT02717195: 1/230 (0.4%) on Olanzapine (serious AE) |
| Condition aggravated | 2,959 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.922 | 1.9 EB05 1.9 · IC025 +0.9 vs other Atypical Antipsychotics: PRR 4.4 (4.3–4.6) | Reporting / coding artifact | age-adj. PRR 1.8 · serious PRR 1.9 | not reported in cached trials |
| Confusional state (confusion) | 2,903 | 3.6 3.4–3.7ROR 3.6 · calibrated p 0.452 | 3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.0 (5.8–6.3) | Labeled (related wording) related wording | age-adj. PRR 3.5 · serious PRR 2.8 | not reported in cached trials |
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.
- Anosognosia — n=476, PRR 320.7
- Total lung capacity increased — n=104, PRR 120.7
- Post-injection delirium sedation syndrome — n=318, PRR 114.3
- Inspiratory capacity decreased — n=98, PRR 108.5
- Camptocormia — n=75, PRR 89.8
- Delusion of grandeur — n=122, PRR 73.5
- Delusional disorder, persecutory type — n=101, PRR 61.4
- Pleurothotonus — n=198, PRR 54.4
- Obsessive-compulsive symptom — n=64, PRR 41.3
- Disinhibition — n=271, PRR 39.6
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Olanzapine are weight increased, diabetes mellitus, toxicity to various agents, nausea, somnolence, fatigue. 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 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 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 135398745 description (ChEBI)
- 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, 1,284 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
OLANZAPINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.