Drug · FAERS side-effect profile with label screen
Buspirone side effects: what 10,952 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Buspirone Hydrochloride
openFDA label
Who reports
10,952 reports · 56% serious · 721 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
FDA label, Indications and Usage
What it is
DESCRIPTION Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound.
FDA label, Description section
Boxed warning
None in the current 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 adverse reaction 1Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 3Not in label — unassessed 31
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. 1,039 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 |
|---|---|---|---|---|---|---|
| Nocturnal fear | 11 | 162.0 87.5–299.8ROR 162.2 · χ² 1,476 / p <1e-300 | 119.0 EB05 70.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pre-existing condition improved | 134 | 41.5 35.0–49.1ROR 42.0 · χ² 5,138 / p <1e-300 | 40.4 EB05 34.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=74 | no trial data cached |
| Product administration interrupted | 148 | 37.6 32.0–44.2ROR 38.1 · χ² 5,134 / p <1e-300 | 36.7 EB05 32.0 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=139 | no trial data cached |
| Infusion site discharge | 31 | 35.3 24.7–50.3ROR 35.4 · χ² 980 / p 2e-215 | 34.0 EB05 25.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 · 100% consumer | no trial data cached |
| Cataplexy | 25 | 34.0 22.9–50.5ROR 34.1 · χ² 755 / p 2e-166 | 32.7 EB05 23.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Sleep-related eating disorder | 11 | 22.6 12.5–41.0ROR 22.7 · χ² 204 / p 1e-46 | 21.4 EB05 12.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Obstructive sleep apnoea syndrome | 16 | 22.1 13.5–36.2ROR 22.2 · χ² 299 / p 3e-67 | 21.3 EB05 13.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Infusion site discomfort | 11 | 20.8 11.5–37.6ROR 20.8 · χ² 186 / p 1e-42 | 19.5 EB05 11.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications | serious n=10 | no trial data cached |
| Generalised anxiety disorder | 15 | 19.7 11.9–32.8ROR 19.7 · χ² 246 / p 1e-55 | 18.9 EB05 11.8 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious n=14 | no trial data cached |
| Narcolepsy | 19 | 19.4 12.4–30.5ROR 19.5 · χ² 311 / p 7e-70 | 18.8 EB05 12.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Postural orthostatic tachycardia syndrome | 12 | 17.6 10.0–31.1ROR 17.7 · χ² 171 / p 3e-39 | 16.5 EB05 9.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Infusion site warmth | 11 | 17.6 9.7–31.9ROR 17.6 · χ² 155 / p 7e-36 | 16.3 EB05 8.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Infusion site haemorrhage | 28 | 16.6 11.5–24.1ROR 16.7 · χ² 393 / p 1e-87 | 16.2 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 · 100% consumer | no trial data cached |
| Infusion site pruritus | 26 | 16.1 10.9–23.6ROR 16.1 · χ² 349 / p 3e-78 | 15.6 EB05 11.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Post-traumatic stress disorder | 51 | 14.6 11.1–19.2ROR 14.7 · χ² 629 / p 5e-139 | 14.4 EB05 11.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=46 | no trial data cached |
| Infusion site reaction | 22 | 14.6 9.6–22.2ROR 14.6 · χ² 263 / p 2e-59 | 13.9 EB05 9.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 · ♀ 100% (drug 75%) · 100% consumer | no trial data cached |
| Sleep apnoea syndrome | 140 | 14.1 11.9–16.6ROR 14.3 · χ² 1,678 / p <1e-300 | 13.9 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Infusion site induration | 10 | 13.5 7.3–25.2ROR 13.5 · χ² 103 / p 2e-24 | 11.5 EB05 5.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Anticholinergic syndrome | 11 | 13.3 7.3–24.0ROR 13.3 · χ² 112 / p 2e-26 | 11.5 EB05 6.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Infusion site pain | 88 | 13.3 10.8–16.3ROR 13.4 · χ² 979 / p 4e-215 | 13.1 EB05 10.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=49 · ♀ 97% (drug 75%) · 86% consumer | no trial data cached |
| Somnambulism | 45 | 13.1 9.8–17.6ROR 13.2 · χ² 489 / p 1e-108 | 12.8 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=34 | no trial data cached |
| Infusion site erythema | 56 | 13.0 10.0–16.9ROR 13.1 · χ² 604 / p 1e-133 | 12.7 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=32 · 86% consumer | no trial data cached |
| Infusion site swelling | 41 | 12.8 9.4–17.4ROR 12.8 · χ² 432 / p 4e-96 | 12.4 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=23 · 83% consumer | no trial data cached |
| Hypotonia neonatal | 10 | 12.6 6.7–23.4ROR 12.6 · χ² 95 / p 1e-22 | 10.5 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Device infusion issue | 16 | 12.6 7.7–20.5ROR 12.6 · χ² 158 / p 2e-36 | 11.4 EB05 6.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=8 | no trial data cached |
| Vascular device infection | 29 | 12.3 8.6–17.8ROR 12.4 · χ² 289 / p 4e-65 | 11.8 EB05 8.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=29 · 79% consumer | no trial data cached |
| Cystitis interstitial | 10 | 12.0 6.4–22.3ROR 12.0 · χ² 89 / p 2e-21 | 9.8 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Serotonin syndrome | 119 | 12.0 10.0–14.3ROR 12.1 · χ² 1,178 / p 2e-258 | 11.8 EB05 10.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 | no trial data cached |
| Infusion site infection | 14 | 11.9 7.0–20.1ROR 11.9 · χ² 128 / p 6e-30 | 10.4 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Infusion site bruising | 13 | 11.7 6.8–20.3ROR 11.8 · χ² 117 / p 2e-27 | 10.2 EB05 5.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Bipolar i disorder | 13 | 11.4 6.6–19.7ROR 11.4 · χ² 113 / p 1e-26 | 9.8 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Biliary dyskinesia | 10 | 11.2 6.0–20.9ROR 11.2 · χ² 82 / p 5e-20 | 9.0 EB05 4.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Seasonal allergy | 82 | 11.2 9.0–13.9ROR 11.2 · χ² 745 / p 3e-164 | 10.9 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=55 · 71% consumer | no trial data cached |
| Catheter site pain | 14 | 10.6 6.3–17.9ROR 10.6 · χ² 111 / p 2e-26 | 9.0 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Bipolar disorder | 60 | 10.5 8.2–13.6ROR 10.6 · χ² 505 / p 4e-112 | 10.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Hangover | 19 | 10.3 6.6–16.2ROR 10.3 · χ² 150 / p 1e-34 | 9.2 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Eyelid pain | 10 | 9.9 5.3–18.4ROR 9.9 · χ² 71 / p 2e-17 | 7.8 EB05 4.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Drug titration error | 13 | 9.6 5.6–16.6ROR 9.7 · χ² 92 / p 5e-22 | 8.0 EB05 4.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Bruxism | 26 | 9.2 6.3–13.6ROR 9.3 · χ² 182 / p 8e-42 | 8.4 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 75%) | no trial data cached |
| Catheter site erythema | 10 | 9.2 4.9–17.1ROR 9.2 · χ² 64 / p 5e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=9 | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 800 | 2.0 1.8–2.1ROR 2.0 · χ² 395 / p 3e-88 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Nausea | 797 | 1.9 1.8–2.1ROR 2.0 · χ² 371 / p 6e-83 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Headache | 731 | 2.2 2.1–2.4ROR 2.3 · χ² 511 / p 2e-113 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Drug ineffective (drug did not work) | 671 | 1.0 0.9–1.0ROR 1.0 · χ² 0 / p 0.247 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Anxiety | 668 | 4.5 4.2–4.8ROR 4.7 · χ² 1,825 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.6 | no trial data cached |
| Dyspnoea (shortness of breath) | 584 | 2.0 1.8–2.1ROR 2.0 · χ² 287 / p 9e-65 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Pain | 578 | 1.8 1.7–1.9ROR 1.8 · χ² 209 / p 1e-47 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Diarrhoea (diarrhea) | 511 | 1.5 1.4–1.7ROR 1.5 · χ² 93 / p 3e-22 | 1.5 EB05 1.4 · IC025 +0.5 | Likely indication confounding term in indications; also in warnings | serious PRR 1.6 | no trial data cached |
| Depression | 503 | 4.2 3.9–4.6ROR 4.4 · χ² 1,241 / p 4e-272 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Dizziness | 501 | 1.9 1.8–2.1ROR 2.0 · χ² 227 / p 2e-51 | 1.9 EB05 1.8 · IC025 +0.8 | Likely indication confounding term in indications; also in warnings | serious PRR 2.3 | no trial data cached |
| Product dose omission issue | 480 | 3.2 3.0–3.5ROR 3.3 · χ² 744 / p 4e-164 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 | no trial data cached |
| Fall | 417 | 2.4 2.2–2.6ROR 2.5 · χ² 344 / p 5e-77 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Off label use (used outside approved label) | 364 | 0.8 0.7–0.9ROR 0.8 · χ² 18 / p 9e-6 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Vomiting | 358 | 1.5 1.3–1.6ROR 1.5 · χ² 53 / p 2e-13 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Cough | 350 | 2.4 2.2–2.7ROR 2.4 · χ² 286 / p 2e-64 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | 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.
- Pre-existing condition improved — n=134, PRR 41.5
- Infusion site discharge — n=31, PRR 35.3
- Cataplexy — n=25, PRR 34.0
- Infusion site haemorrhage — n=28, PRR 16.6
- Post-traumatic stress disorder — n=51, PRR 14.6
- Infusion site reaction — n=22, PRR 14.6
- Sleep apnoea syndrome — n=140, PRR 14.1
- Somnambulism — n=45, PRR 13.1
- Infusion site erythema — n=56, PRR 13.0
- Infusion site swelling — n=41, PRR 12.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Buspirone ↔ Serotonin 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 Buspirone?
In FDA FAERS, the most frequently co-reported reaction terms for Buspirone are fatigue, nausea, headache, anxiety, dyspnoea, pain. 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 Buspirone have an FDA boxed warning?
No. The FDA label retrieved for Buspirone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Buspirone 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 18e90d65-4a3a-864e-e063-6294a90ae99d, effective 20240515; matched on
openfda.generic_name.exact:"BUSPIRONE") - 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, 1,079 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.