Applies to amitriptyline: oral fixed-combination tablets, oral tablets.
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.i j Amitriptyline is not approved for use in pediatric patients <12 years of age.d 103 (See Pediatric Use under Cautions.)
- In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reducedin adults ≥65 years of age with antidepressant therapy compared with placebo.i j
- Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.i j k
- Appropriately monitor and closely observe all patients who are started on amitriptyline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.i j k (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 amitriptyline: compounding powder, intramuscular solution, oral tablet.
General
The most commonly reported side effects were tremors, dizziness, headache, dry mouth, constipation, and nausea.[Ref]
Nervous system
Common (1% to 10%): Ataxia, disturbance in attention, dizziness, dysarthria/speech disorders, dysgeusia, drowsiness, headache, paresthesia, somnolence, tremors
Uncommon (0.1% to 1%): Convulsions
Very rare (less than 0.01%): Akathisia, polyneuropathy
Frequency not reported: Abnormal voluntary movements, ageusia, alteration in cognition, alteration in electroencephalogram patterns, anticholinergic effects, autonomic nervous system function alterations, coma, disturbed concentration, extrapyramidal effects, extremity paresthesia, incoordination, neuromuscular activity alterations, numbness, peculiar taste, peripheral neuropathy, seizures, serotonin syndrome, stroke, syncope, tardive dyskinesia, tingling
Postmarketing reports: Neuroleptic malignant syndrome[Ref]
Cardiovascular
Common (1% to 10%): Atrioventricular (AV) block, bundle branch block, electrocardiogram (ECG) abnormal, electrocardiogram QRS complex prolonged, electrocardiogram QT prolonged, orthostatic hypotension, palpitations, tachycardia
Uncommon (0.1% to 1%): Collapse conditions, hypertension, worsening of cardiac failure
Rare (0.01% to 0.1%): Arrhythmias
Very rare (less than 0.01%): Cardiomyopathies, torsade de pointes
Frequency not reported: Changes in AV conduction, edema, heart block, hypersensitivity myocarditis, hypotension, myocardial infarction, nonspecific ECG changes[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, diarrhea, dry mouth, nausea, tongue edema, vomiting
Rare (0.01% to 0.1%): Paralytic ileus, salivary gland enlargement
Frequency not reported: Black tongue, epigastric distress, parotid swelling, stomatitis[Ref]
Respiratory
Common (1% to 10%): Allergic inflammation of the pulmonary alveoli, allergic inflammation of the lung tissue, alveolitis, congested nose, Loffler's syndrome[Ref]
Psychiatric
Common (1% to 10%): Aggression, agitation, confusional states, libido decrease
Uncommon (0.1% to 1%): Anxiety, hypomania, insomnia, mania, nightmares
Rare (0.01% to 0.1%): Delirium (in elderly patients), hallucinations (in schizophrenic patients), suicidal behavior, suicidal thoughts
Frequency not reported: Behavioral changes, delusions, disorientation, dream disturbances, excitement, increased libido, irritability, libido fluctuations, nightmares, paranoia, restlessness, sleep disturbances
Postmarketing reports: Mental status changes[Ref]
Metabolic
Common (1% to 10%): Hyponatremia, thirst, weight increased
Rare (0.01% to 0.1%): Blood alkaline phosphatase increased, decreased appetite, weight decreased
Frequency not reported: Anorexia, blood sugar level elevation/lowering, increased appetite[Ref]
Genitourinary
Common (1% to 10%): Erectile dysfunction, micturition disorders
Frequency not reported: Breast enlargement, dilation of urinary tract, impotence, interference with sexual function, testicular swelling, urinary frequency[Ref]
Ocular
Common (1% to 10%): Accommodation disorder, mydriasis
Uncommon (0.1% to 1%): Intraocular pressure increased
Very rare (less than 0.01%): Acute glaucoma
Frequency not reported: Blurred vision, disturbance in accommodation, increased intraocular pressure[Ref]
Dermatologic
Common (1% to 10%): Hyperhidrosis
Uncommon (0.1% to 1%): Face edema, rash/skin rash, urticaria
Rare (0.01% to 0.1%): Alopecia, photosensitivity reaction
Frequency not reported: Diaphoresis, increased perspiration, itching/pruritus, mild sweating, photosensitization[Ref]
Other
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Tinnitus
Rare (0.01% to 0.1%): Pyrexia
Frequency not reported: Fever/hyperpyrexia, hyperthermia, malaise, weakness[Ref]
Hepatic
Uncommon (0.1% to 1%): Cholestatic liver disease, hepatic impairment
Rare (0.01% to 0.1%): Jaundice, liver function test abnormal, transaminases increased
Frequency not reported: Altered liver function, hepatic failure, hepatitis[Ref]
Hematologic
Rare (0.01% to 0.1%): Agranulocytosis, bone marrow depression, eosinophilia, leukopenia, purpura, thrombocytopenia[Ref]
Endocrine
Rare (0.01% to 0.1%): Gynecomastia
Frequency not reported: Syndrome of inappropriate antidiuretic hormone (SIADH) secretion[Ref]
Immunologic
Frequency not reported: Positive antinuclear antibodies (ANA), positive rheumatoid factor[Ref]
Musculoskeletal
Frequency not reported: Increased risk of bone fractures, lupus-like syndrome, migratory arthritis
Postmarketing reports: Muscle rigidity[Ref]
