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What the label lists and what reports show

Nefazodone side effects

Nefazodone's FDA label lists its adverse reactions in its own words. FAERS holds 121 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 product availability issue (16 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the nefazodone FDA label on DailyMed (effective July 31, 2025, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Associated with Discontinuation of Treatment Approximately 16% of the 3496 patients who received nefazodone in worldwide premarketing clinical trials discontinued treatment due to an adverse experience. The more common (≥ 1%) events in clinical trials associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for nefazodone compared to placebo) included: nausea (3.5%), dizziness (1.9%), insomnia (1.5%), asthenia (1.3%), and agitation (1.2%). Incidence in Controlled Trials Commonly Observed Adverse Events in Controlled Clinical Trials The most commonly observed adverse events associated with the use of nefazodone (incidence of 5% or greater) and not seen at an equivalent incidence among placebo-treated patients (i.e., significantly higher incidence for nefazodone compared to placebo, p ≤ 0.05) …

Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective July 31, 2025 (SPL set 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f), via openFDA; the full label on DailyMed

What do FAERS reports show?

121 reports list nefazodone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 21 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 18 reactions below, 9 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.

The 25 most reported reactions

  • Depression (a use or a product term, not a reaction)18
  • Drug Ineffective (a use or a product term, not a reaction)17
  • Product Availability Issue16
  • Insomnia (a use or a product term, not a reaction)15
  • Feeling Abnormal13
  • Illness (named in the label)13
  • Withdrawal Syndrome12
  • Drug Hypersensitivity11
  • Anxiety (named in the label)10
  • Nausea (named in the label)10
  • Drug Interaction (a use or a product term, not a reaction)9
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)8
  • Adverse Event7
  • Headache (named in the label)7
  • Weight Decreased6
  • Dizziness (named in the label)5
  • Fatigue (a use or a product term, not a reaction)5
  • Malaise (named in the label)5
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)5
  • Rhabdomyolysis (named in the label)5
  • Abdominal Discomfort4
  • Asthenia (named in the label)4
  • Asthma (named in the label)4
  • Cardiac Disorder4
  • Covid-194

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Nefazodone: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions