Trazodone is a serotonin reuptake inhibitor sold in the U.S. under 3 brand and generic names, for depressive disorder and sleep initiation and maintenance disorders. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Desyrel (application NDA018207). Other trazodone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ( 2 ). • Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2 ). • Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2 ). • When discontinued, gradual dose reduction is recommended ( 2 ). 2.1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response. 2.2 Important Administration Instructions Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.…
Most 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| IT;150;50;50;50 | 150 mg | white | oval | — |
| 8;06 | 100 mg | white | round | — |
| PLIVA;433 | 50 mg | white | round | — |
| PLIVA;441;50;50;50 | 150 mg | white | oval | — |
| PLIVA;434 | 100 mg | white | round | — |
| 8;05 | 50 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Trazodone Hydrochloride
Presence of Foreign Tablets/Capsules
Granules Pharmaceuticals Inc. · Jan 26, 2026
traZODONE Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Zydus Pharmaceuticals (USA) Inc · Dec 19, 2025
The elimination half-life of trazodone is about 7 hours (roughly 5 to 9 hours for the slower elimination phase). Trazodone leaves the body in two phases: a faster early phase of about 3 to 6 hours and a slower phase of about 5 to 9 hours, with the parent drug's elimination half-life reported as about 7 hours. The liver (CYP3A4) breaks it into an active metabolite, m-chlorophenylpiperazine (mCPP), which can build up; clearance varies widely between people and is slowed by strong CYP3A4 inhibitors (e.g., ritonavir roughly doubled trazodone's half-life) and in older adults or those with liver impairment. Extended-release forms have a longer half-life (around 9 to 13 hours).
FDA Clinical Review, NDA 22-411 (trazodone), Pharmacokinetics — parent-drug elimination half-life ~7.1 h; biphasic 3–6 h / 5–9 h ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ). Trazodone hydrochloride tablets are contraindicated in: • Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )].
CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). • CYP3A4 Inhibitors: Consider trazodone dose reduction based on tolerability ( 2.5 , 7 ). • CYP3A4 Inducers: Increase in trazodone dosage may be necessary ( 2.5 , 7 ). • Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). • Warfarin: Monitor for increased or decreased prothrombin time ( 7 ). 7.1 Drugs Having Clinically Important Interactions with Trazodone Table 3 Clinically Important Drug Interactions with Trazodone Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of MAOIs and serotonergic drugs including trazodone increases the risk of serotonin syndrome. Intervention Trazodone is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4), Dosage and Administration (2.3, 2.4), and Warnings and Precautions (5.2)]. Examples isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs including trazodone and other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during trazodone initiation. If serotonin syndrome occurs, consider…
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