Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 and hallucinations have also been reported.
Cardiovascular - Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
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 ).
WARNINGS PROMETHAZINE HCl SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCl SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE.
A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.
IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
Like all medications, Promethazine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: