Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dantrolene sodium
Drug ID BADD_D00577
Description Chemically, dantrolene is a hydantoin derivative, but does not exhibit antiepileptic activity like other hydantoin derivates such as phenytoin.
Indications and Usage For use, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Also used preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.
Marketing Status approved; investigational
ATC Code M03CA01
DrugBank ID DB01219
KEGG ID D02274
MeSH ID D003620
PubChem ID 6604100
TTD Drug ID D0I8DD
NDC Product Code 63629-2169; 0527-3220; 49884-363; 64850-842; 72162-2046; 0904-7211; 0115-4411; 42023-124; 50268-217; 64850-841; 55718-105; 65129-1012; 0115-4433; 72162-2045; 69988-0029; 49884-362; 68084-300; 67262-2000; 0115-4422; 63629-2168; 0527-3219; 71052-508; 55154-7140; 78670-003; 49452-2440; 27505-003; 42023-123; 64850-840; 0527-3221; 10695-140; 69575-4036; 42367-540; 63629-2170; 72162-2047; 49884-364
UNII 287M0347EV
Synonyms Dantrolene | Dantrolene Sodium | Sodium, Dantrolene | Dantrium
Chemical Information
Molecular Formula C14H9N4NaO5
CAS Registry Number 7261-97-4
SMILES C1C(=NC(=O)N1N=CC2=CC=C(O2)C3=CC=C(C=C3)[N+](=O)[O-])[O-].[Na+]
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)
Dysphagia07.01.06.003--
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.004--
Dysuria20.02.02.002--
Eczema23.03.04.006--
Eosinophilia01.02.04.001--
Erythema23.03.06.001--Not Available
Extravasation08.01.03.008--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Flushing23.06.05.003; 08.01.03.025; 24.03.01.002--
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Hair growth abnormal23.02.06.006--Not Available
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Injection site reaction12.07.03.015; 08.02.03.014--
Insomnia17.15.03.002; 19.02.01.002--
Intestinal obstruction07.13.01.002--Not Available
Lacrimation increased06.08.02.004--
Leukopenia01.02.02.001--Not Available
Lymphoma16.20.01.001; 01.12.01.001--Not Available
Malaise08.01.01.003--
Muscular weakness15.05.06.001; 17.05.03.005--
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