Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Promethazine hydrochloride
Drug ID BADD_D01855
Description Promethazine, originally known as 3,277 R.P., is an N-dimethylaminopropyl derivative of [phenothiazine] that was developed in France in 1946.[A189901] Promethazine antagonizes a variety of receptors, allowing it to be used for a number of indications including allergic reactions, pain, sedation, nausea, and vomiting.[A189907,A190153,A190159,A190150,A190171] Promethazine was granted FDA approval before 29 March 1951.[A190177,L4000]
Indications and Usage Promethazine tablets and suppositories are indicated to treat rhinitis, allergic conjunctivitis, allergic reactions to blood or plasma, dermographism, anaphylactic reactions, sedation, nausea, vomiting, pain, motion sickness, and allergic skin reactions.[A189907,L4000] Promethazine cough syrup with phenylephrine and codeine is indicated to relieve cough and upper respiratory symptoms, and nasal congestion associated with allergy or the common cold.[L11326]
Marketing Status approved; investigational
ATC Code D04AA10; R06AD02
DrugBank ID DB01069
KEGG ID D00480
MeSH ID D011398
PubChem ID 6014
TTD Drug ID D0T2XU
NDC Product Code 0641-6082; 0904-7304; 55579-401; 10702-002; 31722-040; 43063-874; 43063-875; 63629-8445; 65841-041; 0404-9940; 0641-0928; 0641-0956; 0641-1495; 0641-6083; 0713-0536; 51927-9018; 54154-011; 69988-0022; 39822-5525; 50090-4453; 50090-4875; 50090-5362; 52584-495; 55154-8080; 55289-928; 60760-456; 61919-047; 63187-829; 65162-522; 65841-040; 65841-042; 0404-9942; 68001-161; 70518-0519; 70934-016; 71205-126; 0591-5307; 0641-6208; 51552-0147; 50090-6216; 51672-5297; 55154-2861; 60687-660; 68788-8162; 70518-1306; 61919-191; 63629-8446; 63739-213; 65162-745; 80425-0265; 0591-5319; 65841-146; 82298-902; 50090-2747; 50090-4812; 51672-5296; 52584-078; 55700-221; 63187-858; 63629-9151; 70408-146; 70518-2488; 70752-138; 71335-1139; 0641-0949; 0713-0526; 38779-0253; 50396-7517; 43063-060; 43063-405; 63187-038; 67296-0564; 67296-1120; 68001-163; 68071-4865; 68084-155; 70518-2481; 70934-858; 51927-0242; 31722-041; 50383-801; 51655-085; 51655-462; 52584-496; 63629-7670; 65162-521; 68788-7886; 70518-3340; 71205-658; 0615-8154; 0641-6085; 0781-1830; 0904-6461; 14593-871; 10135-495; 55579-402; 39822-5550; 50090-0879; 50090-4750; 67296-0086; 0404-9941; 68001-162; 68071-4809; 71335-1359; 71872-7285; 72189-176; 0641-0929; 0641-0948; 0641-1496; 0641-6084; 0713-0132; 57451-1205; 10702-004; 0121-0927; 43063-876; 50090-4608; 50090-4813; 64380-792; 64380-794; 68382-040; 68382-041; 68382-042; 70934-243; 71205-805; 71335-0989; 71872-7077; 0781-1832; 48581-114; 10702-003; 45802-758; 50090-4452; 53746-522; 53746-745; 61919-228; 64380-793; 64679-608; 0641-0955; 27808-051; 43063-447; 45802-759; 45865-592; 51655-140; 53002-4021; 53746-521; 58118-5307
UNII R61ZEH7I1I
Synonyms Promethazine | Prometazin | Proazamine | Rumergan | Diprazin | Isopromethazine | Phenergan | Phenargan | Phensedyl | Pipolfen | Pipolphen | Promet | Promethazine Hydrochloride | Hydrochloride, Promethazine | Prothazin | Pyrethia | Remsed | Atosil | Diphergan
Chemical Information
Molecular Formula C17H20N2S.ClH
CAS Registry Number 58-33-3
SMILES CC(CN1C2=CC=CC=C2SC3=CC=CC=C31)N(C)C.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Apnoea22.02.01.001--
Asthma22.03.01.002; 10.01.03.010--Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Bradycardia02.03.02.002--Not Available
Catatonia19.11.01.001--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Conversion disorder19.24.01.001--Not Available
Coordination abnormal17.02.02.004--Not Available
Delirium19.13.02.001--
Dermatitis23.03.04.002--Not Available
Diplopia17.17.01.005; 06.02.06.002--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dyskinesia17.01.02.006--
Euphoric mood19.04.02.006--
Extrapyramidal disorder17.01.02.007--
Fatigue08.01.01.002--
Hallucination19.10.04.003--
Insomnia19.02.01.002; 17.15.03.002--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Leukopenia01.02.02.001--Not Available
Nasal congestion22.04.04.001--
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Neuroleptic malignant syndrome17.05.02.003; 15.05.04.015; 12.03.01.003; 08.05.01.005--Not Available
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