{ "query": "promethazine", "ingredient": "promethazine", "slug": "promethazine", "rxcui": "8745", "brands": [ "Promethegan", "Phenergan", "Phenadoz" ], "names": [ "promethazine", "promethazine dioxide", "promethazine hydrobromide", "promethazine hydrochloride" ], "classes": [ { "id": "D04AA", "name": "Antihistamines for topical use" }, { "id": "R06AD", "name": "Phenothiazine derivatives" } ], "alternatives": [ "bamipine", "chloropyramine", "chlorphenoxamine", "clemastine", "dimethindene", "diphenhydramine", "isothipendyl", "mequitazine", "methdilazine", "pheniramine", "pyrilamine", "thiethylperazine", "thonzylamine", "trimeprazine", "tripelennamine" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 96, "INTRAMUSCULAR": 17, "INTRAVENOUS": 16, "RECTAL": 7 }, "boxed_warning": "PROMETHAZINE 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.", "indications_and_usage": "INDICATIONS AND USAGE Promethazine is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.", "contraindications": "CONTRAINDICATIONS Promethazine Syrup is contraindicated for use in pediatric patients less than two years of age. Promethazine Syrup is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.", "warnings_and_cautions": "", "warnings": "WARNINGS PROMETHAZINE 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. CNS Depression Promethazine Syrup may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore ...", "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 prome...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Information for Patients Promethazine Syrup may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS-CNS Depression and PRECAUTIONS-Drug Interactions ). Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.", "spl_medguide": "", "clinical_studies": "", "brand_name": "PROMETHAZINE HYDROCHLORIDE", "manufacturer": "Xttrium Laboratories, Inc.", "application_number": "ANDA087953", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20250407", "set_id": "302bfea2-d403-d315-e063-6294a90a37dd", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 32300, "serious": 24260, "death": 3156, "hospitalization": 12947, "primary_suspect": 32185, "top_reactions": [ [ "Intentional Overdose", 3278 ], [ "Nausea", 3156 ], [ "Intentional Self-Injury", 2902 ], [ "Fatigue", 2609 ], [ "Vomiting", 2040 ], [ "Chronic Kidney Disease", 2018 ], [ "Diarrhoea", 1760 ], [ "Pain", 1738 ], [ "Headache", 1631 ], [ "Acute Kidney Injury", 1588 ], [ "Renal Failure", 1434 ], [ "Off Label Use", 1419 ], [ "Anxiety", 1363 ], [ "Dyspnoea", 1305 ], [ "Drug Ineffective", 1303 ] ], "by_year": { "2019": 5958, "2020": 4547, "2021": 2789, "2022": 2320, "2023": 2206, "2024": 2411, "2025": 2210, "2026": 1088 }, "by_year_primary": { "2019": 5956, "2020": 4545, "2021": 2778, "2022": 2301, "2023": 2186, "2024": 2382, "2025": 2193, "2026": 1076 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20140508", "reason": "Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.", "firm": "Zydus Pharmaceuticals USA Inc", "status": "Terminated" } ], "recall_total": 1, "drugsfda": { "applications": 90, "nda": 5, "anda": 67, "first_approval": "19510329", "rems": false, "rems_last": "", "labeling_supplements": 37, "labeling_recent": 0, "sponsors": [ "ABBOTT", "ABLE", "ACTAVIS MID ATLANTIC", "ALPHARMA US PHARMS", "ALTANA", "AM REGENT", "AMNEAL PHARMS", "AMNEAL PHARMS NY" ], "unapproved": false, "first_approval_fmt": "03/29/1951" }, "trials": { "total": 1259, "completed": 796, "terminated": 155, "with_results": 328, "industry": 595, "phase3": 246, "results_share": 0.4120603015075377, "terminated_share": 0.12311358220810167 }, "pubmed": { "rct": 91, "meta": 5, "recent_rct": 6, "cochrane": [ { "pmid": "27885664", "title": "Haloperidol plus promethazine for psychosis-induced aggression", "year": "2016" }, { "pmid": "19588366", "title": "Haloperidol plus promethazine for psychosis-induced aggression", "year": "2009" }, { "pmid": "15654706", "title": "Haloperidol plus promethazine for psychosis induced aggression", "year": "2005" } ] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "promethazine", "Promethegan", "Phenergan", "Phenadoz" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1323113, "beneficiaries": 505949, "spend": 15172917.600000001, "by_brand": [ { "brand": "Promethazine HCl", "claims": 1304504, "per_claim": 10.146069924, "is_generic": true }, { "brand": "Promethegan", "claims": 18532, "per_claim": 104.23943017, "is_generic": false }, { "brand": "Phenergan", "claims": 77, "per_claim": 72.255584416, "is_generic": false } ], "per_claim": 11.467590145361735 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": { "section": "Allergy", "names": [ "promethazine" ], "reason": "Injectable promethazine, an antihistamine used to treat severe urticaria, can cause thrombosis, skin necrosis and gangrene following extravasation or accidental injection into an artery ( Prescrire Int n\u00b0 109). Injectable dexchlorpheniramine, which does not appear to carry these risks, is a better option.", "edition": "2026", "qualifier": "injectable promethazine", "qualified": true, "matched": "promethazine" }, "eml": { "listed": false, "status": "RemovedFromEml", "name": "promethazine", "matched": "promethazine", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 5651, "fills": 1323113, "per_million": 4270.988192240572, "ratio": 1.5424578168650322, "median": 2768.949753790441 }, "scores": { "safety": { "score": 96, "letter": "A", "why": [ "Prescrire lists one form only (injectable promethazine) as a drug to avoid; shown for context, no score effect", "4,271 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-4)", "Death share in reports is near or below the FAERS average (1.1x)" ], "weight": 0.35 }, "evidence": { "score": 48, "letter": "F", "why": [ "91 randomized trials and 5 systematic reviews/meta-analyses indexed in PubMed", "3 independent Cochrane review(s) exist", "Only 41% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 100, "letter": "A", "why": [ "No recalls on record since 2016" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (67 applications)", "15 same-class alternatives exist" ], "weight": 0.1 } }, "total": 86, "grade": "B", "questions": [ "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?", "The most-reported problems in FDA's adverse event data are intentional overdose, nausea, intentional self-injury, fatigue. How would we recognize and handle those?", "Why this one over bamipine, chloropyramine, chlorphenoxamine? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }