Amitriptyline Side Effects

Brand Names: Elavil

Please note - some side effects for Amitriptyline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Amitriptyline - for the Consumer

Amitriptyline

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amitriptyline:

Blurred vision; change in sexual desire or ability; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; tiredness; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark urine; delusions; difficulty speaking or swallowing; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; numbness or tingling in an arm or leg; one-sided weakness; seizures; severe or persistent dizziness or headache; severe or persistent trouble sleeping; slurred speech; suicidal thoughts or actions; tremor; trouble urinating; uncontrolled muscle movements (eg, of face, tongue, arms, legs); unusual bleeding or bruising; unusual or severe mental or mood changes; vision problems; yellowing of the skin or eyes.

Amitriptyline/Chlordiazepoxide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amitriptyline/Chlordiazepoxide:

Abnormal skin sensations; bloating; blurred vision; constipation; diarrhea; disturbed concentration; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; restlessness; tiredness; upset stomach; vomiting; weakness; weight gain or loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; decreased sexual ability; decreased or increased urination; decreased coordination; delusions; disorientation; fast or irregular heartbeat; fainting; fever, chills, or persistent sore throat; hallucinations; involuntary movements of tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs; lightheadedness; mental or mood changes; numbness of an arm or leg; one-sided weakness; pounding in the chest; seizures; severe constipation; speech problems; sudden severe dizziness, headache, stomach pain, or vomiting; tremors; unusual bleeding or bruising; yellowing of the skin or eyes.

Amitriptyline/Perphenazine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amitriptyline/Perphenazine:

Blurred vision; changes in color of cornea and lens; changes in menstrual cycle; constipation; diarrhea; dizziness; drowsiness; dry mouth; flushing; headache; lack of energy; loss of appetite; nausea; sleeplessness; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; altered mental abilities, including lack of response to your surroundings; breast growth; changes in vision or other vision problems; chest pain; confusion; difficulty sleeping; difficulty speaking or swallowing; difficulty urinating; drooling from the mouth; excessive drowsiness; excessive hunger, thirst, or urination; fainting; feeling of irritability or hostility; fever; impulsive behavior or other unusual changes in behavior; inability to urinate; involuntary movements of tongue, face, mouth, or jaw, sometimes with involuntary movements of the arms and legs; loss of bladder control; mental or mood changes; muscle rigidness or stiffness; nightmares; panic attacks; rapid or irregular heartbeat; restlessness; ringing in the ears; severe nervousness or anxiety; severe restlessness; severe stomach pain; sore throat; suicidal thoughts; sweating; swelling of the legs and feet; tremors; uncoordinated movements; weakness in the arms or legs; worsening feelings of depression; yellowing of the skin or eyes.

Amitriptyline Side Effects - for the Professional

Amitriptyline

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when Amitriptyline is administered.

Cardiovascular:  Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation.

CNS and Neuromuscular:  Coma; seizures; hallucinations; delusion; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns.

Anticholinergic:  Paralytic ileus; hyperpyrexia; urinary retention; dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth.

Allergic:  Skin rash; urticaria; photosensitization; edema of face and tongue.

Hematologic:  Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia.

Gastrointestinal:  Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue.

Endocrine:  Testicular swelling and gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido; impotence; elevation and lowering of blood sugar levels.

Other:  Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration.

Withdrawal Symptoms: After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reductions has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance.

These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants.

Causal Relationship Unknown: Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians.

Body as a Whole:  Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor).

Digestive:  Hepatic failure, ageusia.

Postmarketing Adverse Events: A syndrome resembling neuroleptic malignant syndrome (NMS) has been very rarely reported after starting or increasing the dose of Amitriptyline hydrochloride, with and without concomitant medications known to cause NMS. Symptoms have included muscle rigidity, fever, mental status changes, diaphoresis, tachycardia, and tremor.

Very rare cases of serotonin syndrome (SS) have been reported with Amitriptyline hydrochloride in combination with other drugs that have a recognized association with SS.

Very rare cases of cardiomyopathy have been reported with Amitriptyline.

Side Effects by Body System

Other

Anticholinergic effects have been reported in more than 50% of patients taking amitriptyline and include dry mouth, blurry vision, constipation and urinary retention. In one study, anticholinergic and antimuscarinic side effects occurred in 84% of patients.

Nervous system

Some investigators have estimated an incidence of 4 to 5 tricyclic- induced seizures per 1,000 treated patients.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Nervous system side effects are among the most common. Drowsiness, dizziness, sedation and fatigue occur commonly. Delirium, tinnitus, sleep abnormalities, cognitive impairment (especially in the elderly), a tardive dyskinesia- like syndrome, dystonic reactions and seizures have also been reported.

Cardiovascular

Both antiarrhythmic and proarrhythmic effects have been associated with the use of tricyclic antidepressant therapy. Caution is recommended if amitriptyline must be used in patients with cardiovascular disease.

Cardiovascular side effects have included orthostatic hypotension, tachycardia, QRS widening, conduction abnormalities, malignant arrhythmias, and malignant hypertension. Very rare cases of cardiomyopathy have also been reported.

Psychiatric

Psychiatric side effects associated with the use of amitriptyline have included hypomania and visual hallucinations. Suicidal ideation, paradoxical aggressiveness, and mental status changes have also been reported with use of this and other tricyclic antidepressants.

Gastrointestinal

A study of 26,005 antidepressant users has reported 2.3 times more upper GI bleeding episodes with the use of non-SSRI's. Upper gastrointestinal tract bleeding was observed in 2.5 times more frequently in patients receiving amitriptyline.

Gastrointestinal side effects are most likely due to the anticholinergic properties of the drug and commonly include dry mouth (79%) and constipation (55%). Nausea, vomiting, and diarrhea have also been reported. In addition, ischemic colitis has been associated with the use of amitriptyline.

General

Increased appetite and weight gain have been associated with use of amitriptyline.

Other

Withdrawal symptoms, including nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating and salivation have been reported after abrupt discontinuation of other tricyclic antidepressants.

Genitourinary

Genitourinary side effects have included urinary retention and sexual dysfunction (including decreased penile circumference and decreased amplitude and duration of nocturnal erections).

Hematologic

Hematologic side effects are rare. Cases of reversible agranulocytosis and eosinophilia have been rarely associated with use of tricyclic antidepressants.

Endocrine

Endocrinologic problems associated with the use of amitriptyline are rare, and include hyponatremia in association with the syndrome of inappropriate secretion of antidiuretic hormone.

Hepatic

Hepatic side effects are rare. Elevated liver function tests, drug-induced hepatitis, and acute hepatic necrosis have been rarely reported.

Dermatologic

Dermatologic side effects have included rare cases of rashes and a single report of erythema annulare centrifigum.

Immunologic

Immunologic side effects of amitriptyline have included rare associated cases of a lupoid- like reaction.

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