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Vanatrip Side Effects

Generic name: amitriptyline

Medically reviewed by Drugs.com. Last updated on Sep 19, 2022.

Note: This document contains side effect information about amitriptyline. Some of the dosage forms listed on this page may not apply to the brand name Vanatrip.

For the Consumer

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]

Frequently asked questions

References

1. "Product Information. Elavil (amitriptyline)." Stuart Pharmaceuticals (2002):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.