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Phenergan (promethazine)
Promethazine (Phenergan) is a phenothiazine antihistamine/antiemetic approved in 1951. Widely used for nausea but carries FDA black box warnings. Available generically. Contraindicated in children under 2.
At a glance
| Generic name | promethazine |
|---|---|
| Also known as | Phenergan |
| Sponsor | Generic (originally Wyeth/Pfizer) |
| Drug class | Phenothiazine antihistamine/antiemetic |
| Target | Aldehyde oxidase, 5-hydroxytryptamine receptor 6, FAD-linked sulfhydryl oxidase ALR |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1951-01-01 (United States) |
Approved indications
- Allergic conjunctivitis
- General anesthesia
- Nausea and vomiting
- Seasonal allergic rhinitis
- Sedation
- Urticaria
- Vasomotor rhinitis
Boxed 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.
Common side effects
- Drowsiness
- Sedation
- Somnolence
- Blurred vision
- Dizziness
- Confusion
- Disorientation
- Lassitude
- Tinnitus
- Incoordination
- Fatigue
- Euphoria
Serious adverse events
- Respiratory depression (potentially fatal)
- Apnea (potentially fatal)
- Neuroleptic malignant syndrome (potentially fatal)
- Convulsive seizures
- Agranulocytosis
- Thrombocytopenic purpura
- Hallucinations
- Angioneurotic edema
- Oculogyric crisis
- Torticollis
Key clinical trials
- Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units (NA)
- A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hyp (Phase 3)
- Replication of the ONTARGET Antihypertensive Trial in Healthcare Claims Data (N/A)
- Phase II Non-Randomized, Unblinded, Single-Center Trial of Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer Versus Historical Best Supportive Care (Phase 2)
- Metabolic Abnormalities, Telmisartan and HIV Infection (Phase 2)
- A Randomized, Open-label, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover Bioequivalence Study of Test Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) of Pharmtechnol (Phase 1)
- A Phase 1 Study of Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (Phase 1)
- A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smolde (Phase 3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Phenergan CI brief — competitive landscape report
- Phenergan updates RSS · CI watch RSS
- Generic (originally Wyeth/Pfizer) portfolio CI