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)
Consciousness fluctuating17.02.04.0190.000058%-
Deformity08.01.03.0220.000038%-
Psychological trauma19.01.02.0170.000058%-
Poor feeding infant14.03.02.022; 18.04.06.0060.000135%-
Disorganised speech17.02.08.017; 19.19.02.0050.000038%-
Helplessness19.01.02.0130.000077%-
Drug chemical incompatibility08.06.03.0080.000058%-
Drug therapeutic incompatibility08.06.03.0100.000038%-
Therapeutic product effect decreased08.06.01.0500.000085%-
Therapy non-responder08.06.01.0630.000085%-
The 8th Page    First    Pre   8    Total 8 Pages