What the label lists and what reports show
Trazodone side effects
Trazodone's FDA label: “Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ).” FAERS holds 15,550 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,157 reports).
- Generic listed
- Boxed warning
Check it at the source: the trazodone FDA label on DailyMed (effective January 22, 2026, Zydus Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of trazodone hydrochloride tablets?Trazodone hydrochloride tablets can cause serious side effects or death, including: See "What is the most important information I should know about Trazodone?" Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea. Irregular or fast heartbeat or faint (QT prolongation) Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing) Unusual bruising or bleeding Erection lasting for more than 6 hours (priapism) Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania). Withdrawal symptoms. Symptoms of withdrawal can include anxiety, agitation, and sleep problems. […]
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective January 22, 2026 (SPL set 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ).
Table 2 Common Adverse Reactions Occurring in ≥ 2% of Trazodone-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies
| Reaction | Trazodone N=142 | Placebo N=95 | Trazodone N=157 | Placebo N=158 |
|---|---|---|---|---|
| Skin Condition/Edema | 3% | 1% | 7% | 1% |
| Blurred Vision | 6% | 4% | 15% | 4% |
| Constipation | 7% | 4% | 8% | 6% |
| Dry Mouth | 15% | 8% | 34% | 20% |
| Hypertension | 20% | 1% | 1% | * |
| Hypotension | 7% | 1% | 4% | 0 |
| Syncope | 3% | 2% | 5% | 1% |
| Confusion | 5% | 0 | 6% | 8% |
| Decreased Concentration | 3% | 2% | 1% | 0 |
| Disorientation | 2% | 0 | * | 0 |
| Dizziness/Light-Headedness | 20% | 5% | 28% | 15% |
| Drowsiness | 24% | 6% | 41% | 20% |
| Fatigue | 11% | 4% | 6% | 3% |
| Headache | 10% | 5% | 20% | 16% |
| Nervousness | 15% | 11% | 6% | 8% |
| Abdominal/Gastric Disorder | 4% | 4% | 6% | 4% |
| Diarrhea | 0 | 1% | 5% | 1% |
| Nausea/Vomiting | 10% | 1% | 13% | 10% |
| Aches/Pains | 6% | 3% | 5% | 3% |
| Incoordination | 5% | 0 | 2% | * |
| Tremors | 3% | 1% | 5% | 4% |
| Eyes Red/Tired/Itching | 3% | 0 | 0 | 0 |
| Head Full-Heavy | 3% | 0 | 0 | 0 |
| Malaise | 3% | 0 | 0 | 0 |
| Nasal/Sinus Congestion | 3% | 0 | 6% | 3% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Cardiac Arrythmias [see Warnings and Precautions ( 5.3 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Priapism [see Warnings and Precautions ( 5.6 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.7 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.8 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.9 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.10 )] Hyponatremia [see Warnings and Precautions ( 5.11 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical …
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective January 22, 2026 (SPL set 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9), via openFDA; the full label on DailyMed
What do FAERS reports show?
15,550 reports list trazodone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,593 are coded as a death and 5,279 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Trazodone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions