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Phenergan (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.
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).

Paradoxical Reactions
Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl 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.

To report SUSPECTED ADVERSE REACTIONS, contact Renaissance Pharma, Inc. at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .



REPORTS OF SUSPECTED PHENERGAN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Phenergan. The information is not vetted and should not be considered as verified clinical evidence.

Possible Phenergan side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from Brazil on 2011-10-07

Patient: 58 year old female weighing 89.0 kg (195.8 pounds)

Reactions: Pruritus, Self Esteem Decreased, Psoriasis, Somnolence, Cholelithiasis, Renal Impairment, Arthralgia, Feeling Jittery, Blood Glucose Fluctuation, Psoriatic Arthropathy, Nervousness

Suspect drug(s):
Fluoxetine
    Indication: Psoriatic Arthropathy

Phenergan
    Indication: Product Used FOR Unknown Indication

Cortisone Acetate

Remicade
    End date: 2011-08-01

Meloxicam
    Indication: Psoriatic Arthropathy

Remicade
    Start date: 2011-09-23

Remicade
    Indication: Psoriatic Arthropathy

Cortisone Acetate
    Indication: Psoriatic Arthropathy

Other drugs received by patient: Pressat; Moduretic 5-50; Omeprazole; Tylenol-500; Losartan Potassium



Possible Phenergan side effects / adverse reactions in 55 year old male

Reported by a consumer/non-health professional from Brazil on 2011-11-28

Patient: 55 year old male

Reactions: Flushing, Agitation, Psychotic Disorder, Insomnia, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Phenergan
    Indication: Hypersensitivity

Haldol
    Indication: Psychotic Disorder
    End date: 2011-01-01

Other drugs received by patient: Dalmadorm; Trileptal; Levothyroxine Sodium; Biperiden Hydrochloride TAB; Lansoprazole



Possible Phenergan side effects / adverse reactions in 35 year old male

Reported by a physician from United States on 2011-12-06

Patient: 35 year old male

Reactions: Pain, Colitis, Skin Warm, Gastroenteritis Viral

Suspect drug(s):
Phenergan
    Indication: Gastroenteritis Viral
    Start date: 2011-11-23

Humira
    Indication: Crohn's Disease
    Start date: 2011-09-30

Oxycodone HCL
    Dosage: as needed every 6 hours
    Indication: Gastroenteritis Viral
    Start date: 2011-11-23

Other drugs received by patient: Ativan; Lortab; Imuran; Ondansetron; Dicyclomine; Nexium; Ciprofloxacin; Multi-Vitamin; Flagyl; Prednisone TAB; Stool Softener



See index of all Phenergan side effect reports >>

Drug label data at the top of this Page last updated: 2014-06-23

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