Adgan Side Effects

Generic Name: promethazine

Please note - some side effects for Adgan 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 by Body System

Nervous system

Nervous system side effects have been reported the most frequently. These have included excessive sedation, drowsiness, fatigue, paradoxical excitation, confusion, disorientation, tremors, convulsive seizures, and decreased motor coordination. Extrapyramidal effects (including oculogyric crises, torticollis and tongue protrusion), encephalitic symptoms, convulsions, and psychosis have been rarely reported.

Other

Neuroleptic malignant syndrome has been rarely observed during treatment with promethazine. It usually occurs within the first 30 days after exposure to neuroleptics.

Fever, altered consciousness, labile blood pressure, autonomic dysfunction, and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome is associated with a case fatality rate ranging from 5% to 20%. Immediate discontinuation of promethazine and intensive monitoring and supportive care are indicated.

Local

Local side effects have been associated with the inadvertent intraarterial injection of promethazine which carries a high risk of distal necrosis and frequently requires amputation of the affected limb. Subcutaneous injection has more rarely caused chemical irritation and necrosis.

Respiratory

Respiratory side effects have rarely included respiratory depression and arrest, especially with parenteral administration of promethazine. Equipment for resuscitation should be available when parenteral promethazine is used. Asthma and nasal stuffiness have also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and dry mouth.

Hypersensitivity

Hypersensitivity side effects have included rare reports of rash, pruritus, hypotension, photosensitivity, and tachycardia.

Hematologic

Hematologic side effects have included rare cases of neutropenia. Leukopenia, thrombocytopenia, thrombocytopenic purpura, and agranulocytosis have also been reported.

Cardiovascular

Cardiovascular side effects have rarely included tachycardia, bradycardia, and increased or decreased blood pressure. Prolongation of the QT interval, heart block, and malignant arrhythmias have been reported in association with other phenothiazines.

Immunologic

Immunologic side effects have included rare reports of a systemic lupus erythematosus syndrome.

Hepatic

Hepatic side effects have included jaundice.

Dermatologic

Dermatologic side effects have included dermatitis, photosensitivity, and urticaria.

Psychiatric

Psychiatric side effects have included hallucinations. Other paradoxical reactions following a single dose have included nightmares, delirium and agitated behavior.

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