Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Codeine sulfate
Drug ID BADD_D00517
Description The relief of pain (analgesia) is a primary goal for enhancing the quality of life of patients and for increasing the ability of patients to engage in day to day activities. Codeine, an opioid analgesic, was originally approved in the US in 1950 and is a drug used to decrease pain by increasing the threshold for pain without impairing consciousness or altering other sensory functions. Opiates such as codeine are derived from the poppy plant, _Papaver somniferum_ (Papaveraceae).[A175096] Codeine is utilized as a central analgesic, sedative, hypnotic, antinociceptive, and antiperistaltic agent, and is also recommended in certain diseases with incessant coughing.[LABEL,A175096]
Indications and Usage Codeine sulfate is a form of this drug that is commonly used. It is available in tablet form [FDA label] and indicated for the relief of mild to moderately severe pain, where the use of an opioid analgesic is appropriate [FDA label]. The solution form is used by itself or combined in a syrup with other drugs and is used as a cough suppressant in adults aged 18 and above [L5521], [L5524].
Marketing Status approved; illicit
ATC Code R05DA04
DrugBank ID DB00318
KEGG ID D03580
MeSH ID D003061
PubChem ID 5359613
TTD Drug ID D03DIG
NDC Product Code 0054-0243; 0054-0244; 0527-1698; 0054-0245; 0406-1580; 0527-1699
UNII 11QV9BS0CB
Synonyms Codeine | Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5alpha,6alpha)- | N-Methylmorphine | N Methylmorphine | Isocodeine | Codeine Phosphate | Ardinex
Chemical Information
Molecular Formula C36H44N2O10S
CAS Registry Number 1420-53-7
SMILES CN1CCC23C4C1CC5=C2C(=C(C=C5)OC)OC3C(C=C4)O.CN1CCC23C4C1CC5=C2C(=C(C=C5)OC)OC3C(C =C4)O.OS(=O)(=O)O
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Anxiety19.06.02.002--
Asthenia08.01.01.001--Not Available
Cardiac arrest02.03.04.001--
Constipation07.02.02.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysphoria19.04.02.004--Not Available
Dyspnoea22.02.01.004; 02.11.05.003--
Euphoric mood19.04.02.006--
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Headache17.14.01.001--
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypersensitivity10.01.03.003--
Hypotension24.06.03.002--
Insomnia19.02.01.002; 17.15.03.002--
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Palpitations02.11.04.012--
Pancreatitis07.18.01.001--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Respiratory arrest22.02.01.009--Not Available
Respiratory depression22.02.01.010; 17.02.05.047--Not Available
Sedation17.02.04.005--Not Available
Shock24.06.02.002--Not Available
Somnolence17.02.04.006; 19.02.05.003--
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