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· Brand: Raldesy Tm, Raldesy

Trazodone Side Effects: Common, Serious & FDA Warnings

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Based on 15,000+ FDA adverse event reports, the most-reported trazodone reactions include fatigue, nausea, and headache. FDA reports 2 active Class II recalls of trazodone, primarily for failed dissolution specifications. The FDA-approved label carries a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Trazodone

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for trazodone. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

ReactionReports% of total
Fatigue1,1427.5%
Nausea1,1127.3%
Headache9156.0%
Pain8175.3%
Diarrhoea8045.2%
Vomiting6934.5%
Insomnia6764.4%
Depression6624.3%
Dyspnoea6344.1%
Dizziness6144.0%
Source: FDA FAERS·Updated ·n=15,321+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flagReports% of total
Serious reports (any flag)——
Hospitalization——
Death reported as outcome
FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established.
4603.0%

From the FDA-approved label, Section 5.1: Suicidal Thoughts and Behaviors in Pediatric and Young Adult

Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1.
Show full Section 5.1See less
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 1 Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo < 18 14 additional patients 18 to 24 5 additional patients Decreases Compared to Placebo 25 to 64 1 fewer patient ≥ 65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing trazodone, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

From the FDA-approved label, Section 5.4: Orthostatic Hypotension and Syncope

Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.
Source: DailyMed (trazodone label)·Updated

Trazodone Recalls

FDA enforcement actions matched to trazodone via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

DateReasonClassQuantityStatus
2026-02-11Presence of Foreign Tablets/Capsules
Granules Pharmaceuticals Inc.
Class II71424 bottles.Ongoing
2026-01-07Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Zydus Pharmaceuticals (USA) Inc
Class III2,136 1000-count bottlesOngoing
Source: FDA Drug Enforcement Reports·Updated ·Refreshes every 6 hours·verify on FDA →
Show 1 closed recall (2021 to 2021)

Includes resolved and terminated recalls matched to trazodone. Most recent first.

DateReasonClassQuantityStatus
2021-06-02CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
Class II91 CARTONTerminated

Trazodone Shortages

FDA-listed shortages of trazodone products. Strength and dosage-form level detail.

No active or recent shortages of trazodone are listed. We refresh this view daily.
Source: FDA Drug Shortages·Updated

Is Trazodone Safe?

Trazodone is FDA-approved. The label's Warnings and Precautions section covers suicidal thoughts and behaviors in pediatric and young adult (Section 5.1), serotonin syndrome (Section 5.2), cardiac arrhythmias (Section 5.3), orthostatic hypotension and syncope (Section 5.4), increased risk of bleeding (Section 5.5), priapism (Section 5.6), activation of mania or (Section 5.7), discontinuation syndrome (Section 5.8), potential for cognitive and motor impairment (Section 5.9), angle-closure (Section 5.10), hyponatremia (Section 5.11).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (trazodone label)·Updated

FDA-Approved Indications

Trazodone is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

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.
Source: DailyMed (trazodone label)·Updated ·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of trazodone?
Fatigue, nausea, and headache are among the most-reported reactions in FDA FAERS data for trazodone. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is trazodone the same as Raldesy Tm?
Trazodone is the generic name; Raldesy Tm is a brand name for the same active ingredient. Other brand names include Raldesy. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has trazodone been recalled?
Yes. Trazodone has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by contamination or foreign material and CGMP deviations. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are trazodone's current ongoing recalls about?
Active trazodone recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is contamination or foreign material. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Does trazodone have an FDA boxed warning?
Yes. The FDA-approved label for trazodone carries a boxed warning. Boxed warnings are the FDA's strongest cautions. See the "FDA Boxed Warning" section above for the verbatim warning text.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

SourceEndpointRefresh
FAERS reactionsopenFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports.Daily
RecallsopenFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.6 hours
ShortagesFDA Drug Shortages list.Daily
Boxed warnings & label sectionsopenFDA /drug/label.json. Labels are stable; monthly cadence is sufficient.Monthly
Condition categoriesSynonym-mapped from drug_labels.indications. Methodology at /methodology/.Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.