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What the label lists and what reports show

Nortriptyline side effects

Nortriptyline's FDA label lists its adverse reactions in its own words. FAERS holds 5,761 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 pain (730 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the nortriptyline FDA label on DailyMed (effective December 4, 2024); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Note – Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered. Cardiovascular – Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric – Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis. Neurologic – Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus. Anticholinergic – Dry mouth and, rarely, associated sublingual adenitis; …

Source: FDA drug label, SpecGx LLC, effective December 4, 2024 (SPL set e17dc299-f52d-414d-ab6e-e809bd6f8acb), via openFDA; the full label on DailyMed

What do FAERS reports show?

5,761 reports list nortriptyline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 708 are coded as a death and 1,472 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, 6 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

  • Drug Ineffective (a use or a product term, not a reaction)853
  • Off Label Use (a use or a product term, not a reaction)793
  • Pain730
  • Headache (named in the label)715
  • Fatigue (named in the label)622
  • Nausea (named in the label)574
  • Hyperhidrosis556
  • Hypersensitivity490
  • Drug Hypersensitivity445
  • Constipation (named in the label)433
  • Hypertension (named in the label)424
  • Rheumatoid Arthritis410
  • Hepatic Enzyme Increased409
  • Overdose (a use or a product term, not a reaction)399
  • Joint Swelling389
  • Immunodeficiency383
  • Back Pain382
  • Drug Intolerance377
  • Upper Respiratory Tract Infection373
  • Product Use Issue (a use or a product term, not a reaction)372
  • Rash (named in the label)368
  • Food Allergy367
  • Asthma364
  • Pyrexia358
  • Exposure During Pregnancy (a use or a product term, not a reaction)343

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

What next?

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