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What the label lists and what reports show

Amoxapine side effects

Amoxapine's FDA label lists its adverse reactions in its own words. FAERS holds 475 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 poisoning (40 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the amoxapine FDA label on DailyMed (effective December 18, 2024, Chartwell RX, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse reactions reported in controlled studies in the United States are categorized with respect to incidence below. Following this is a listing of reactions known to occur with other antidepressant drugs of this class. Incidence Greater Than 1% The most frequent types of adverse reactions occurring with amoxapine in controlled clinical trials were sedative and anticholinergic: these included drowsiness (14%), dry mouth (14%), constipation (12%), and blurred vision (7%). Less frequently reported reactions are: CNS and Neuromuscular: anxiety, insomnia, restlessness, nervousness, palpitations, tremors, confusion, excitement, nightmares, ataxia, alterations in EEG patterns. Allergic: edema, skin rash. Endocrine: elevation of prolactin levels. Gastrointestinal: nausea. Other: dizziness, headache, fatigue, weakness, excessive appetite, increased perspiration. …

Source: FDA drug label, Chartwell RX, LLC, effective December 18, 2024 (SPL set eed5e856-dd7b-4eaa-9dad-508f2bef9328), via openFDA; the full label on DailyMed

What do FAERS reports show?

475 reports list amoxapine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 181 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 17 reactions below, 5 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

  • Poisoning40
  • Drug Abuse37
  • Drug Ineffective (a use or a product term, not a reaction)28
  • Toxicity To Various Agents28
  • Completed Suicide (an outcome recorded in the report)27
  • Somnolence26
  • Depression (a use or a product term, not a reaction)22
  • Pyrexia21
  • Asphyxia20
  • Overdose (a use or a product term, not a reaction)20
  • Tachycardia (named in the label)18
  • Death (an outcome recorded in the report)17
  • Suicide Attempt17
  • Diarrhoea (named in the label)16
  • Insomnia (named in the label)16
  • Nausea (named in the label)15
  • Dizziness (named in the label)14
  • Drug Interaction (a use or a product term, not a reaction)14
  • Hepatic Function Abnormal14
  • Malaise14
  • Off Label Use (a use or a product term, not a reaction)14
  • Pain14
  • Asthenia13
  • Convulsion13
  • Intentional Overdose (a use or a product term, not a reaction)13

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

What next?

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