Applies to nortriptyline: oral capsules and oral solution.
Warning
-
Suicidality
- Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.h i Nortriptyline is not approved for use in pediatric patients.a (See Pediatric Use under Cautions.)
- In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.h i
- Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.h i j
- Appropriately monitor and closely observe all patients who are started on nortriptyline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.h i j (See Worsening of Depression and Suicidality Risk under Cautions.)
Side effects include:
Anticholinergic effects (e.g., dry mouth, constipation, vision disturbance), orthostatic hypotension, sedation, weakness, lethargy, fatigue.
For Healthcare Professionals
Applies to nortriptyline: compounding powder, oral capsule, oral solution.
Nervous system
Frequency not reported: Alteration in electroencephalogram (EEG) patterns, ataxia, dizziness, drowsiness, extrapyramidal symptoms, extremity paresthesia, headache, incoordination, mydriasis, numbness, peculiar taste, peripheral neuropathy, seizures, stroke, tingling, tremors[Ref]
Psychiatric
Frequency not reported: Agitation, anxiety, confusional states with hallucinations, delusions, disorientation, exacerbation of psychosis, hypomania, increased/decreased libido, insomnia, nightmares, panic, restlessness, suicidal behaviors, suicidal ideation[Ref]
Gastrointestinal
Frequency not reported: Abdominal cramps, black tongue, constipation, diarrhea, dry mouth, epigastric distress, gingivitis, nausea, paralytic ileus, parotid swelling, stomatitis, sublingual adenitis, tongue edema, vomiting[Ref]
Cardiovascular
Frequency not reported: Arrhythmias, edema, flushing, general edema, heart block, hypertension, hypotension, myocardial infarction, palpitation, tachycardia
Postmarketing reports: Brugada syndrome[Ref]
Genitourinary
Frequency not reported: Breast enlargement, delayed micturition, dilation of the urinary tract, galactorrhea, impotence, nocturia, urinary frequency, urinary retention, testicular swelling[Ref]
Dermatologic
Frequency not reported: Alopecia, face edema, itching, perspiration, petechia, photosensitization, skin rash, urticaria[Ref]
Hematologic
Frequency not reported: Agranulocytosis, aplastic anemia, bone marrow depression, eosinophilia, purpura, thrombocytopenia[Ref]
Other
Frequency not reported: Drug fever, fatigue, malaise, tinnitus, weakness[Ref]
Hepatic
Frequency not reported: Altered liver function, hepatitis, jaundice (simulating obstructive), liver necrosis[Ref]
Metabolic
Frequency not reported: Anorexia, elevation/depression of blood sugar levels, weight gain/loss[Ref]
Ocular
Frequency not reported: Blurred vision, disturbance of accommodation
Postmarketing reports: Angle-closure glaucoma[Ref]
Endocrine
Frequency not reported: Gynecomastia, syndrome of inappropriate antidiuretic hormone (SIADH) secretion[Ref]
Hypersensitivity
Frequency not reported: Cross sensitivity (with other tricyclic drugs)[Ref]
Musculoskeletal
Frequency not reported: Increased risk of bone fractures[Ref]
