ADVERSE REACTIONS
Central Nervous System
Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness, confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.
Cardiovascular
Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Thrombophlebitis, venous thrombosis, and phlebitis at the injection site have been reported and in some cases have required surgical intervention. INTRA-ARTERIAL INJECTION MAY RESULT IN GANGRENE OF THE AFFECTED EXTREMITY (see CONTRAINDICATIONS, WARNINGS—Injection Site Reactions, and DOSAGE AND ADMINISTRATION).
Dermatologic
Dermatitis, photosensitivity, urticaria.
Hematologic
Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Gastrointestinal
Dry mouth, nausea, vomiting, jaundice.
Respiratory
Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS—Respiratory Depression.)
Other
Angioneurotic edema. Neuroleptic Malignant Syndrome (potentially fatal) has also been reported. (See WARNINGS—Neuroleptic Malignant Syndrome.) Administration of Promethazine HCl Injection has resulted in nerve damage ranging from temporary sensory loss to palsies and paralysis. Injection into or near a nerve may result in permanent tissue damage. Subcutaneous injection has resulted in tissue necrosis. Injection site reactions including burning, erythema, pain, and edema have been reported. Administration of Promethazine HCl Injection has resulted in abscesses and/or tissue necrosis and gangrene, regardless of the route of administration. In some cases, surgical intervention (including fasciotomy, skin graft, and/or amputation) may be required (see CONTRAINDICATIONS, WARNINGS—Injection Site Reactions, and DOSAGE AND ADMINISTRATION).
Paradoxical Reactions
Hyperexcitability and abnormal movements have been reported in patients following a single administration of Promethazine HCl Injection. Consideration should be given to the discontinuation of Promethazine HCl Injection and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.
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