DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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 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



See index of all Promethazine side effect reports >>

Drug label data at the top of this Page last updated: 2006-11-27

-- advertisement -- The American Red Cross
We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2009