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Elavil Side Effects

Generic name: amitriptyline

Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.

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

Applies to amitriptyline: oral tablet.

Warning

Oral route (Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients.

Serious side effects of Elavil

Along with its needed effects, amitriptyline (the active ingredient contained in Elavil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amitriptyline:

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking amitriptyline:

Symptoms of Overdose

Other side effects of Elavil

Some side effects of amitriptyline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

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;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

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.