Amitriptyline hydrochloride adverse reactions
|AMITRIPTYLINE HYDROCHLORIDE® |
FDA Package Insert
|Indications and Usage|
|Dosage and Administration|
|Warnings and Precautions|
|Use in Specific Populations|
|How Supplied/Storage and Handling|
|Patient Counseling Information|
|Labels and Packages|
|Clinical Trials on 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.
Myocardial infarction; stroke; non specific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation.
CNS and Neuromuscular
Coma; seizures; hallucinations; delusions; 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.
Paralytic ileus; hyperpyrexia; urinary retention, dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased intraocular pressure, mydriasis; dry mouth.
Skin rash; urticaria; photosensitization; edema of face and tongue.
Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia.
Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue.
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.
Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration.
After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction 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).
Hepatic failure, ageusia.
Post-marketing 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 HCl.
Adapted from the FDA Package Insert.