Trazodone side effects: what 15,549 FDA adverse event reports show
Drug class
Selective serotonin reuptake inhibitor
Label matched
Trazodone Hydrochloride (Trazodone Hydrochloride)
Who reports
15,549 reports · 67% serious · 1,593 with death outcome · 66% female
Used for
Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
What it is
Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]- 1,2,4-triazolo[4, 3-a]pyridin-3(2H)-one hydrochloride.
Boxed warning
SUICIDAL THOUGHTS and BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] .
Causality screen of the 40 strongest signals
What the badges mean
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,107 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 |
|---|---|---|---|---|---|---|
| Presbyacusis | 88 | 534.4 417.5–684.0ROR 537.4 · χ² 33,039 / p <1e-300 | 352.2 EB05 294.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 66%) | not reported in cached trials |
| Neovascularisation | 37 | 227.8 160.8–322.7ROR 228.3 · χ² 6,940 / p <1e-300 | 177.0 EB05 134.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Pleural thickening | 72 | 159.3 124.8–203.3ROR 160.0 · χ² 9,974 / p <1e-300 | 137.3 EB05 112.7 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=72 · ♀ 100% (drug 66%) | not reported in cached trials |
| Analgesic drug level above therapeutic | 14 | 142.1 81.9–246.5ROR 142.2 · χ² 1,647 / p <1e-300 | 109.7 EB05 69.4 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Pleural fibrosis | 89 | 127.5 102.7–158.4ROR 128.3 · χ² 10,081 / p <1e-300 | 113.7 EB05 95.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=89 · ♀ 100% (drug 66%) | not reported in cached trials |
| Blood magnesium increased | 71 | 115.0 90.3–146.5ROR 115.5 · χ² 7,281 / p <1e-300 | 103.1 EB05 84.5 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=71 · ♀ 100% (drug 66%) | not reported in cached trials |
| Nail bed inflammation | 23 | 105.1 68.8–160.6ROR 105.3 · χ² 2,102 / p <1e-300 | 90.4 EB05 63.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Ejection fraction | 37 | 91.1 65.3–127.1ROR 91.3 · χ² 3,003 / p <1e-300 | 81.8 EB05 62.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 100% (drug 66%) | not reported in cached trials |
| Confabulation | 16 | 85.8 51.8–142.2ROR 85.9 · χ² 1,181 / p 4e-259 | 73.8 EB05 48.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Antidepressant drug level above therapeutic | 15 | 83.1 49.3–140.0ROR 83.2 · χ² 1,069 / p 8e-235 | 71.5 EB05 46.0 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 48 | 74.5 55.7–99.6ROR 74.7 · χ² 3,226 / p <1e-300 | 68.7 EB05 53.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 66%) | not reported in cached trials |
| Sensitisation | 40 | 74.3 54.1–102.1ROR 74.5 · χ² 2,670 / p <1e-300 | 68.2 EB05 52.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 100% (drug 66%) | not reported in cached trials |
| Anticholinergic syndrome | 79 | 70.3 56.1–88.1ROR 70.7 · χ² 5,062 / p <1e-300 | 65.8 EB05 54.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=79 · 91% clinician | not reported in cached trials |
| Bone cyst | 36 | 53.7 38.5–74.9ROR 53.8 · χ² 1,738 / p <1e-300 | 50.3 EB05 38.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 66%) | not reported in cached trials |
| Nasal mucosal disorder | 22 | 52.7 34.4–80.7ROR 52.8 · χ² 1,024 / p 5e-225 | 48.7 EB05 33.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Total lung capacity decreased | 48 | 41.6 31.3–55.5ROR 41.8 · χ² 1,807 / p <1e-300 | 39.8 EB05 31.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 66%) | not reported in cached trials |
| Deafness neurosensory | 90 | 38.1 30.9–46.9ROR 38.3 · χ² 3,121 / p <1e-300 | 36.8 EB05 30.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 95% (drug 66%) | not reported in cached trials |
| Polycystic ovaries | 41 | 36.1 26.5–49.2ROR 36.2 · χ² 1,329 / p 3e-291 | 34.7 EB05 26.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 100% (drug 66%) | not reported in cached trials |
| Osteosclerosis | 41 | 36.0 26.4–49.0ROR 36.1 · χ² 1,323 / p 5e-290 | 34.5 EB05 26.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 100% (drug 66%) | not reported in cached trials |
| Streptococcal sepsis | 28 | 32.4 22.3–47.1ROR 32.4 · χ² 801 / p 2e-176 | 31.0 EB05 22.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 66%) | not reported in cached trials |
| Epigastric discomfort | 85 | 29.9 24.1–37.0ROR 30.0 · χ² 2,291 / p <1e-300 | 29.1 EB05 24.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=83 · ♀ 100% (drug 66%) | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 29 | 28.6 19.8–41.3ROR 28.6 · χ² 729 / p 7e-161 | 27.6 EB05 20.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 66%) | not reported in cached trials |
| Ejection fraction abnormal | 25 | 28.0 18.8–41.6ROR 28.0 · χ² 611 / p 3e-135 | 26.9 EB05 19.2 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=25 · ♀ 100% (drug 66%) | not reported in cached trials |
| Lung opacity | 49 | 26.1 19.7–34.7ROR 26.2 · χ² 1,138 / p 1e-249 | 25.4 EB05 20.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 66%) | not reported in cached trials |
| Sopor | 254 | 26.1 23.1–29.5ROR 26.5 · χ² 5,994 / p <1e-300 | 25.6 EB05 23.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 94% clinician | not reported in cached trials |
| Pneumococcal infection | 11 | 25.8 14.2–46.8ROR 25.8 · χ² 233 / p 7e-53 | 24.2 EB05 14.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Hemianopia | 18 | 24.7 15.5–39.4ROR 24.8 · χ² 379 / p 8e-85 | 23.7 EB05 15.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Nephrectomy | 25 | 23.1 15.6–34.3ROR 23.1 · χ² 498 / p 1e-110 | 22.4 EB05 15.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 66%) | not reported in cached trials |
| Tracheobronchitis | 13 | 23.0 13.3–39.9ROR 23.1 · χ² 248 / p 3e-56 | 21.9 EB05 13.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Pleuritic pain | 44 | 21.7 16.1–29.3ROR 21.8 · χ² 836 / p 4e-184 | 21.2 EB05 16.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 66%) | not reported in cached trials |
| Urine leukocyte esterase positive | 11 | 21.3 11.7–38.6ROR 21.3 · χ² 190 / p 2e-43 | 19.9 EB05 11.3 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Rhinitis allergic | 66 | 20.3 15.9–25.9ROR 20.4 · χ² 1,176 / p 6e-258 | 19.9 EB05 16.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 94% (drug 66%) | not reported in cached trials |
| Blepharospasm | 92 | 20.3 16.5–24.9ROR 20.4 · χ² 1,642 / p <1e-300 | 19.9 EB05 16.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 66%) | not reported in cached trials |
| Pseudomonal sepsis | 26 | 20.2 13.7–29.7ROR 20.2 · χ² 448 / p 8e-100 | 19.6 EB05 14.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 66%) | not reported in cached trials |
| Substance use | 22 | 19.5 12.8–29.7ROR 19.5 · χ² 363 / p 3e-81 | 18.9 EB05 13.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=22 | not reported in cached trials |
| Arteriosclerosis coronary artery | 76 | 15.7 12.5–19.6ROR 15.8 · χ² 1,018 / p 9e-224 | 15.4 EB05 12.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=76 | not reported in cached trials |
| Diabetic complication | 29 | 15.4 10.7–22.2ROR 15.4 · χ² 372 / p 3e-83 | 14.9 EB05 10.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=9 | not reported in cached trials |
| Vascular device infection | 50 | 15.1 11.4–19.9ROR 15.1 · χ² 637 / p 9e-141 | 14.8 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 66%) | not reported in cached trials |
| Shoulder pain | 11 | 15.1 8.3–27.3ROR 15.1 · χ² 129 / p 3e-30 | 13.5 EB05 7.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Abortion missed | 14 | 15.0 8.8–25.4ROR 15.0 · χ² 167 / p 2e-38 | 13.8 EB05 8.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Trazodone 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 (0 of 40 signal terms matched).
- NCT00775203 — A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid® OAD and Pl (N=412, PHASE3; 19 AE terms posted; arms: Trazodone Contramid OAD; Placebo)
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) | 1,212 | 1.2 1.2–1.3ROR 1.3 · χ² 60 / p 4e-15 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Fatigue (tiredness) | 1,157 | 2.0 1.9–2.1ROR 2.1 · χ² 608 / p 2e-134 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00775203: 30/202 (14.9%) on Trazodone; 17/204 (8.3%) control |
| Nausea | 1,123 | 1.9 1.8–2.0ROR 2.0 · χ² 514 / p 5e-114 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00775203: 42/202 (20.8%) on Trazodone; 26/204 (12.7%) control |
| Headache | 924 | 2.0 1.9–2.1ROR 2.1 · χ² 469 / p 3e-104 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.4 | NCT00775203: 67/202 (33.2%) on Trazodone; 55/204 (27.0%) control |
| Pain | 823 | 1.8 1.7–1.9ROR 1.8 · χ² 303 / p 3e-68 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled — boxed warning exact term | serious PRR 1.8 | NCT00775203: 1/202 (0.5%) on Trazodone (serious AE) |
| Diarrhoea (diarrhea) | 817 | 1.7 1.6–1.8ROR 1.8 · χ² 250 / p 2e-56 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00775203: 19/202 (9.4%) on Trazodone; 23/204 (11.3%) control |
| Off label use (used outside approved label) | 742 | 1.2 1.1–1.2ROR 1.2 · χ² 16 / p 4e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Vomiting | 704 | 2.0 1.9–2.2ROR 2.1 · χ² 373 / p 2e-83 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Insomnia (trouble sleeping) | 694 | 3.5 3.3–3.8ROR 3.6 · χ² 1,259 / p 4e-276 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | not reported in cached trials |
| Depression | 674 | 4.0 3.7–4.3ROR 4.1 · χ² 1,517 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.5 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 643 | 1.5 1.4–1.7ROR 1.6 · χ² 122 / p 1e-28 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 1.5 | not reported in cached trials |
| Dizziness | 634 | 1.7 1.6–1.9ROR 1.7 · χ² 194 / p 2e-44 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00775203: 50/202 (24.8%) on Trazodone; 25/204 (12.3%) control |
| Fall | 622 | 2.5 2.3–2.7ROR 2.6 · χ² 580 / p 2e-128 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | not reported in cached trials |
| Asthenia (weakness) | 543 | 1.9 1.8–2.1ROR 2.0 · χ² 254 / p 2e-57 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.8 | not reported in cached trials |
| Anxiety | 523 | 2.5 2.3–2.7ROR 2.5 · χ² 464 / p 4e-103 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | 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.
- Presbyacusis — n=88, PRR 534.4
- Neovascularisation — n=37, PRR 227.8
- Pleural thickening — n=72, PRR 159.3
- Pleural fibrosis — n=89, PRR 127.5
- Nail bed inflammation — n=23, PRR 105.1
- Ejection fraction — n=37, PRR 91.1
- Bronchopulmonary aspergillosis allergic — n=48, PRR 74.5
- Sensitisation — n=40, PRR 74.3
- Anticholinergic syndrome — n=79, PRR 70.3
- Bone cyst — n=36, PRR 53.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Trazodone ↔ Priapism.
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 Trazodone?
In FDA FAERS, the most frequently co-reported reaction terms for Trazodone are fatigue, nausea, headache, pain, diarrhoea, vomiting. 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 Trazodone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS and BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] .
Do FAERS signals prove that Trazodone 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 04a676ee-358e-484d-9de4-a9a88d908ba8, effective 20240226; matched on
openfda.generic_name.exact:"TRAZODONE HYDROCHLORIDE") - 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, 1,147 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
TRAZODONE, results-bearing studies sorted by enrollment)
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.