Promethazine (Promethazine Hydrochloride) - Side Effects and Adverse Reactions

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.

REPORTS OF SUSPECTED PROMETHAZINE SIDE EFFECTS / ADVERSE REACTIONS

Possible Promethazine side effects / adverse reactions in 53 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 53 year old female

Reactions: Wrong Drug Administered, Adverse Drug Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Copaxone
    Indication: Multiple Sclerosis
    Start date: 2009-03-01
    End date: 2011-09-01

Promethazine
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Other drugs received by patient: Tizanidine Hydrochloride; Leucovorin Calcium; Diazepam; Vicodin; Immune Globulin NOS; Eruda; Assorted Inhalers; Ketoprofen; Carisoprodol; Cyanocobalamin-Tannin Complex; Modafinil

Possible Promethazine side effects / adverse reactions in 85 year old male

Reported by a pharmacist from United States on 2011-10-07

Patient: 85 year old male weighing 79.7 kg (175.3 pounds)

Reactions: Dysarthria, Abnormal Behaviour, Hallucination

Suspect drug(s):
Promethazine
    Dosage: 12.5 mg
    Indication: Vomiting
    Start date: 2011-10-01
    End date: 2011-10-05

Promethazine
    Dosage: 12.5 mg
    Indication: Nausea
    Start date: 2011-10-01
    End date: 2011-10-05

Possible Promethazine side effects / adverse reactions in 38 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-21

Patient: 38 year old female weighing 63.0 kg (138.6 pounds)

Reactions: Injection Site Erythema, Drug Administration Error, Injection Site Pain, Injection Site Swelling

Suspect drug(s):
Promethazine
    Indication: Nausea
    Start date: 2011-09-19
    End date: 2011-09-19

Promethazine
    Indication: Vomiting
    Start date: 2011-09-19
    End date: 2011-09-19