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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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO PROMETHAZINE
Below is a sample of reports where side effects / adverse reactions may be related to Promethazine. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Promethazine side effects / adverse reactions in 85 year old female
Reported by a pharmacist from United States on 2007-01-04
Patient: 85 year old female weighing 54.0 kg (118.8 pounds)
Reactions: Grand MAL Convulsion, Apnoea, Oxygen Saturation Decreased, Loss of Consciousness
Adverse event resulted in: life threatening event, hospitalization, disablity
Suspect drug(s):
Promethazine
Possible Promethazine side effects / adverse reactions in 81 year old female
Reported by a physician from Germany on 2007-01-12
Patient: 81 year old female
Reactions: Hypotonia
Adverse event resulted in: hospitalization
Suspect drug(s):
Zeldox (Capsules)
Dosage: daily dose:40mg-freq:unknown
Administration route: Oral
Indication: Schizophrenia, Paranoid Type
Start date: 2004-07-28
End date: 2004-07-30
Promethazine
Dosage: daily dose:150mg-freq:unknown
Administration route: Oral
Oxazepam
Dosage: daily dose:15mg-freq:unknown
Administration route: Oral
Remergil
Dosage: daily dose:45mg-freq:unknown
Administration route: Oral
Cipramil
Dosage: daily dose:40mg
Administration route: Oral
Other drugs received by patient: Ismo; Pantozol; Molsidomine; Dimeticone
Possible Promethazine side effects / adverse reactions in 70 year old female
Reported by a pharmacist from United States on 2007-01-24
Patient: 70 year old female
Reactions: Cardio-Respiratory Arrest, Convulsion
Adverse event resulted in: life threatening event
Suspect drug(s):
Promethazine
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