Quetiapine side effects: what 191,471 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Quetiapine Extended Release
Who reports
191,471 reports · 79% serious · 28,195 with death outcome · 59% female
Used for
Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder, manic or mixed episodes (1.2) Bipolar disorder, depressive episodes (1.2) Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia.
What it is
Quetiapine is a dibenzothiazepine, a N-alkylpiperazine and a N-arylpiperazine. It has a role as an adrenergic antagonist, a histamine antagonist, a serotonergic antagonist, a dopaminergic antagonist and a second generation antipsychotic.
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS 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 [see Warnings and Precautions (5.1) ] .
Causality screen of the 40 strongest signals
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). 1,219 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood prolactin abnormal | 535 | 175.7 153.1–201.6ROR 176.2 · calibrated p 1e-9 ✓ | 67.0 EB05 62.4 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=530 | not reported in cached trials |
| Anosognosia | 459 | 162.2 140.3–187.5ROR 162.6 · calibrated p 3e-9 ✓ | 64.9 EB05 60.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=457 · ♀ 80% (drug 59%) | not reported in cached trials |
| Grip strength | 136 | 156.6 120.3–203.8ROR 156.7 · calibrated p 6e-9 ✓ | 63.6 EB05 55.2 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=136 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Lupus vulgaris | 658 | 136.3 121.5–152.9ROR 136.7 · calibrated p 1e-8 ✓ | 60.4 EB05 56.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=658 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 931 | 99.2 90.7–108.4ROR 99.7 · calibrated p 1e-7 ✓ | 51.9 EB05 49.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=931 · ♀ 100% (drug 59%) · 92% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 300 | 89.5 76.8–104.3ROR 89.6 · calibrated p 3e-7 ✓ | 49.1 EB05 44.6 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=300 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Stubbornness | 174 | 73.1 60.3–88.6ROR 73.1 · calibrated p 1e-6 ✓ | 43.6 EB05 38.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=172 · ♀ 100% (drug 59%) | not reported in cached trials |
| Adjustment disorder with depressed mood | 776 | 68.4 62.5–74.9ROR 68.7 · calibrated p 2e-6 ✓ | 42.1 EB05 39.7 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=775 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 1,178 | 66.3 61.7–71.3ROR 66.8 · calibrated p 2e-6 ✓ | 41.3 EB05 39.4 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=1,178 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| C-reactive protein | 328 | 61.8 54.0–70.8ROR 61.9 · calibrated p 4e-6 ✓ | 39.5 EB05 36.0 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=328 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 234 | 55.4 47.3–64.9ROR 55.5 · calibrated p 8e-6 ✓ | 36.8 EB05 33.0 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=224 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Retinitis | 561 | 55.3 49.9–61.2ROR 55.4 · calibrated p 7e-6 ✓ | 36.7 EB05 34.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=561 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Dislocation of vertebra | 737 | 54.1 49.5–59.1ROR 54.3 · calibrated p 8e-6 ✓ | 36.2 EB05 34.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=737 · ♀ 100% (drug 59%) · 93% clinician | not reported in cached trials |
| Rheumatic fever | 1,417 | 52.4 49.2–55.8ROR 52.8 · calibrated p 1e-5 ✓ | 35.5 EB05 34.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=1,417 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 174 | 51.2 42.7–61.3ROR 51.2 · calibrated p 1e-5 ✓ | 34.8 EB05 30.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=174 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Diabetic coma | 886 | 49.8 46.0–53.9ROR 50.0 · calibrated p 1e-5 ✓ | 34.3 EB05 32.4 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=884 | not reported in cached trials |
| X-ray abnormal | 498 | 42.2 38.0–46.8ROR 42.3 · calibrated p 4e-5 ✓ | 30.5 EB05 28.3 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=498 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,495 | 38.1 35.9–40.4ROR 38.4 · calibrated p 7e-5 ✓ | 28.4 EB05 27.2 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=1,495 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Bezoar | 335 | 35.0 30.9–39.5ROR 35.0 · calibrated p 1e-4 ✓ | 26.6 EB05 24.3 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=335 · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,719 | 34.8 32.9–36.7ROR 35.1 · calibrated p 1e-4 ✓ | 26.5 EB05 25.4 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 19.4 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Neuroleptic malignant syndrome | 2,768 | 33.0 31.7–34.5ROR 33.5 · calibrated p 1e-4 ✓ | 25.5 EB05 24.7 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 25.7 · serious PRR 18.4 · 91% clinician | NCT00600756: 1/402 (0.2%) on Quetiapine (serious AE) |
| Duodenal ulcer perforation | 1,657 | 31.7 30.1–33.5ROR 32.0 · calibrated p 2e-4 ✓ | 24.7 EB05 23.7 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 18.0 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Multiple drug therapy | 155 | 31.1 26.0–37.2ROR 31.1 · calibrated p 2e-4 ✓ | 24.2 EB05 21.2 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=152 · ♀ 0% (drug 59%) · 100% clinician | NCT00206102: 1/496 (0.2%) on Quetiapine (serious AE) |
| Metabolic syndrome | 364 | 31.0 27.6–34.8ROR 31.0 · calibrated p 2e-4 ✓ | 24.2 EB05 22.2 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=315 | not reported in cached trials |
| Facet joint syndrome | 696 | 30.8 28.4–33.6ROR 31.0 · calibrated p 2e-4 ✓ | 24.2 EB05 22.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=695 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Anticholinergic syndrome | 349 | 30.5 27.1–34.4ROR 30.6 · calibrated p 2e-4 ✓ | 23.9 EB05 21.9 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=346 · 100% clinician | not reported in cached trials |
| Cogwheel rigidity | 226 | 29.7 25.7–34.4ROR 29.8 · calibrated p 3e-4 ✓ | 23.4 EB05 21.0 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=222 · 100% clinician | not reported in cached trials |
| Peripheral venous disease | 834 | 28.7 26.6–31.0ROR 28.9 · calibrated p 3e-4 ✓ | 22.9 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=831 · ♀ 100% (drug 59%) · 92% clinician | not reported in cached trials |
| Disturbance in social behaviour | 491 | 28.5 25.8–31.5ROR 28.5 · calibrated p 3e-4 ✓ | 22.7 EB05 21.1 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=478 | not reported in cached trials |
| Seronegative arthritis | 231 | 28.2 24.4–32.6ROR 28.2 · calibrated p 4e-4 ✓ | 22.5 EB05 20.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=231 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Pemphigus | 2,516 | 27.6 26.4–28.8ROR 28.0 · calibrated p 4e-4 ✓ | 22.2 EB05 21.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Schizoaffective disorder | 362 | 27.5 24.5–30.9ROR 27.6 · calibrated p 4e-4 ✓ | 22.1 EB05 20.2 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=344 | NCT00206102: 19/586 (3.2%) on Quetiapine (serious AE) |
| Sopor | 2,520 | 25.3 24.2–26.4ROR 25.6 · calibrated p 6e-4 ✓ | 20.6 EB05 20.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | age-adj. PRR 20.0 · serious PRR 15.1 · 94% clinician | not reported in cached trials |
| Psychiatric decompensation | 357 | 24.4 21.7–27.3ROR 24.4 · calibrated p 8e-4 ✓ | 20.0 EB05 18.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=344 · ♀ 24% (drug 59%) | not reported in cached trials |
| Muscle injury | 1,499 | 24.3 23.0–25.7ROR 24.5 · calibrated p 7e-4 ✓ | 20.0 EB05 19.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Porphyria acute | 249 | 23.9 20.9–27.5ROR 24.0 · calibrated p 9e-4 ✓ | 19.7 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=249 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Type 2 diabetes mellitus | 5,970 | 23.4 22.7–24.0ROR 24.1 · calibrated p 8e-4 ✓ | 19.4 EB05 18.9 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 12.8 | not reported in cached trials |
| Gestational diabetes | 829 | 23.3 21.6–25.1ROR 23.4 · calibrated p 1e-3 ✓ | 19.3 EB05 18.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=791 · ♀ 100% (drug 59%) | not reported in cached trials |
| Diabetic neuropathy | 850 | 22.4 20.8–24.1ROR 22.5 · calibrated p 0.001 ✓ | 18.7 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=842 · 100% consumer | not reported in cached trials |
| Temperature regulation disorder | 373 | 22.4 20.0–25.0ROR 22.4 · calibrated p 0.001 ✓ | 18.7 EB05 17.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=364 · ♀ 83% (drug 59%) | 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 | 8,382 | 9.49.2–9.6 | signal |
| Suicidality | 19,489 | 9.49.2–9.5 | signal |
| Pancreatitis | 4,347 | 6.26.0–6.4 | signal |
| Hyperglycaemia / diabetes | 15,480 | 5.15.0–5.2 | signal |
| Rhabdomyolysis / myopathy | 2,875 | 4.03.8–4.1 | signal |
| Depression | 9,589 | 3.83.8–3.9 | signal |
| Seizure | 4,713 | 2.72.6–2.7 | signal |
| Hyponatraemia | 1,875 | 2.62.5–2.7 | signal |
| Arrhythmia / qt | 4,412 | 2.52.5–2.6 | signal |
| Liver injury | 6,730 | 2.52.4–2.5 | signal |
| Fall / fracture | 6,596 | 1.91.9–2.0 | raised |
| Interstitial lung disease | 1,628 | 1.91.8–2.0 | raised |
| Dependence / withdrawal | 3,947 | 1.51.4–1.5 | raised |
| Hypoglycaemia | 1,269 | 1.51.4–1.5 | raised |
| Severe cutaneous reaction | 936 | 1.41.3–1.5 | raised |
| Serious infection | 9,560 | 1.41.3–1.4 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Quetiapine 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 (3 of 40 signal terms matched).
- NCT00206102 — A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizo (N=1098, PHASE4; 151 AE terms posted; arms: Quetiapine Fumarate; Risperidone)
- NCT00600756 — Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone (N=798, PHASE3; 49 AE terms posted; arms: Quetiapine XR; Risperidone)
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) | 12,862 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.356 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.6 | not reported in cached trials |
| Off label use (used outside approved label) | 12,335 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.709 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | age-adj. PRR 1.5 · serious PRR 1.7 | not reported in cached trials |
| Toxicity to various agents | 10,154 | 7.0 6.9–7.1ROR 7.3 · calibrated p 0.086 | 6.6 EB05 6.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 6.1 · serious PRR 4.9 · 92% clinician | not reported in cached trials |
| Insomnia (trouble sleeping) | 9,281 | 3.9 3.8–4.0ROR 4.1 · calibrated p 0.366 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.4 · serious PRR 3.0 | NCT00206102: 89/586 (15.2%) on Quetiapine |
| Fatigue (tiredness) | 9,208 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.519 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.4 | NCT00206102: 60/586 (10.2%) on Quetiapine |
| Weight increased (weight gain) | 8,382 | 4.2 4.2–4.3ROR 4.4 · calibrated p 0.312 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 3.5 · serious PRR 4.2 | NCT00206102: 69/586 (11.8%) on Quetiapine |
| Diabetes mellitus | 8,357 | 13.3 13.0–13.6ROR 13.9 · calibrated p 0.010 ✓ | 11.9 EB05 11.7 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | age-adj. PRR 5.6 · serious PRR 8.1 | NCT00206102: 3/496 (0.6%) on Quetiapine (serious AE) |
| Drug interaction | 8,348 | 6.0 5.9–6.2ROR 6.3 · calibrated p 0.134 | 5.8 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 5.3 · serious PRR 4.5 | not reported in cached trials |
| Somnolence (drowsiness) | 8,321 | 4.7 4.6–4.8ROR 4.9 · calibrated p 0.251 | 4.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.4 · serious PRR 4.4 | NCT00206102: 169/586 (28.8%) on Quetiapine |
| Nausea | 8,282 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.412 | 1.1 EB05 1.1 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.3 | NCT00206102: 1/496 (0.2%) on Quetiapine (serious AE) |
| Depression | 8,023 | 3.9 3.9–4.0ROR 4.1 · calibrated p 0.363 | 3.8 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 3.3 · serious PRR 3.2 | NCT00206102: 13/586 (2.2%) on Quetiapine (serious AE) |
| Anxiety | 7,885 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.572 | 3.0 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.7 · serious PRR 2.6 | NCT00206102: 3/586 (0.5%) on Quetiapine (serious AE) |
| Completed suicide (death by suicide) | 7,301 | 10.3 10.1–10.6ROR 10.7 · calibrated p 0.026 ✓ | 9.5 EB05 9.3 · IC025 +3.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 7.8 · serious PRR 6.9 · 95% clinician | NCT00206102: 2/586 (0.3%) on Quetiapine (serious AE) |
| Pain | 7,139 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.497 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.3 · ♀ 80% (drug 59%) | NCT00206102: 2/586 (0.3%) on Quetiapine (serious AE) |
| Dizziness | 7,119 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.704 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.6 | NCT00206102: 2/496 (0.4%) on Quetiapine (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.
- Anosognosia — n=459, PRR 162.2
- Grip strength — n=136, PRR 156.6
- Lupus vulgaris — n=658, PRR 136.3
- Deep vein thrombosis postoperative — n=931, PRR 99.2
- Stubbornness — n=174, PRR 73.1
- Retinitis — n=561, PRR 55.3
- Dislocation of vertebra — n=737, PRR 54.1
- Rheumatic fever — n=1,417, PRR 52.4
- Subcutaneous drug absorption impaired — n=174, PRR 51.2
- Facet joint syndrome — n=696, PRR 30.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Quetiapine (antipsychotics) ↔ Diabetes mellitus.
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 Quetiapine?
In FDA FAERS, the most frequently co-reported reaction terms for Quetiapine are toxicity to various agents, insomnia, fatigue, weight increased, diabetes mellitus, 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 Quetiapine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS 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 [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Quetiapine 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 04cd529c-198b-5b85-e063-6294a90a4684, effective 20251121; matched on
openfda.generic_name.exact:"QUETIAPINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 5002 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, 1,259 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
QUETIAPINE, 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.