Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Promethazine
Drug ID BADD_D01854
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 D00494
MeSH ID D011398
PubChem ID 4927
TTD Drug ID D0T2XU
NDC Product Code 54348-117; 65162-678
UNII FF28EJQ494
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
CAS Registry Number 60-87-7
SMILES CC(CN1C2=CC=CC=C2SC3=CC=CC=C31)N(C)C
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)
Vision blurred17.17.01.010; 06.02.06.0070.000135%
Visual impairment06.02.10.0130.000038%Not Available
Vomiting07.01.07.0030.000323%
Withdrawal syndrome08.06.02.012; 19.07.06.0230.000038%Not Available
Mental status changes19.07.01.0010.000188%Not Available
Peripheral swelling02.05.04.015; 08.01.03.0530.000104%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000038%
Balance disorder08.01.03.081; 17.02.02.0070.000085%Not Available
Nerve injury12.01.12.002; 17.02.10.007--Not Available
Musculoskeletal stiffness15.03.05.0270.000038%Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.000169%Not Available
Infusion site pain12.07.05.002; 08.02.05.0140.000085%Not Available
Affect lability19.04.01.0010.000038%Not Available
Pulmonary mass22.02.07.0040.000135%Not Available
Temperature intolerance08.01.09.0220.000038%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000038%
Major depression19.15.01.0030.000058%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000131%Not Available
Mental disorder19.07.01.0020.000038%Not Available
Abnormal behaviour19.01.01.0010.000058%Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Psychotic disorder19.03.01.0020.000038%
Pulmonary function test decreased13.19.01.001--Not Available
Muscle contracture15.03.05.0240.000058%Not Available
Infusion site extravasation12.07.05.008; 08.02.05.0070.000131%
Intellectual disability17.03.07.001; 19.21.06.0010.000038%Not Available
Injury associated with device12.01.08.035; 08.07.01.0120.000131%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000077%Not Available
Irregular breathing22.02.01.026--Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000231%
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