Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nitrofurantoin (monohydrate/macrocrystals)
Drug ID BADD_D01578
Description Nitrofurantoin is a nitrofuran antibiotic used to treat uncomplicated urinary tract infections.[L6856,L6859,L6862] Nitrofurantoin is converted by bacterial nitroreductases to electrophilic intermediates which inhibit the citric acid cycle as well as synthesis of DNA, RNA, and protein.[A179824] This drug is more resistant to the development of bacterial resistance because it acts on many targets at once.[A179824] Nitrofurantoin is a second line treatment to [trimethoprim]/[sulfamethoxazole].[A179830] Nitrofurantoin was granted FDA approval on 6 February 1953.[L6895]
Indications and Usage Nitrofurantoin is indicated to treat acute uncomplicated urinary tract infections.[L6856,L6859,L6862]
Marketing Status approved; vet_approved
ATC Code J01XE01
DrugBank ID DB00698
KEGG ID D00439
MeSH ID D009582
PubChem ID 6604200
TTD Drug ID D0R0BX
NDC Product Code 82982-017; 65862-929; 0480-3470; 55700-822; 72789-234; 63629-1459; 68071-4428; 16714-439; 60760-194; 63187-995; 76420-195; 82982-052; 70518-1087; 42708-178; 53002-7041; 68084-446; 71205-546; 50090-3737; 63629-1748; 68788-7092; 70934-269; 0185-0122; 59746-762; 68071-4367; 72789-242
UNII 927AH8112L
Synonyms Nitrofurantoin | Furadoine | Nitrofurantoin, Monohydrate | Furantoin | Macrodantin | Nitrofurantoin Sodium Salt | Furadantin | Furadantine | Furadonine
Chemical Information
Molecular Formula C8H6N4O5
CAS Registry Number 67-20-9
SMILES C1C(=O)NC(=O)N1N=CC2=CC=C(O2)[N+](=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)
Haemolytic anaemia01.06.03.002--Not Available
Headache17.14.01.001--
Hepatic necrosis09.01.07.002--
Hepatitis09.01.07.004--Not Available
Hepatitis chronic active11.07.01.002; 09.01.07.006--Not Available
Hypersensitivity10.01.03.003--
Jaundice cholestatic09.01.01.005--Not Available
Leukopenia01.02.02.001--Not Available
Liver disorder09.01.08.001--Not Available
Lung disorder22.02.07.001--Not Available
Malaise08.01.01.003--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neuropathy peripheral17.09.03.003--Not Available
Nystagmus17.02.02.006; 06.05.02.006--
Optic neuritis10.02.01.097; 17.04.05.001; 06.04.08.002--Not Available
Pancreatitis07.18.01.001--
Pruritus23.03.12.001--
Pseudomembranous colitis07.19.01.003; 11.02.02.002--Not Available
Pyrexia08.05.02.003--
Rash erythematous23.03.13.029--Not Available
Rash maculo-papular23.03.13.004--
Sialoadenitis11.01.04.002; 07.06.04.002--
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Superinfection11.01.08.009--Not Available
Thrombocytopenia01.08.01.002--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.12.04.027; 10.02.02.006--
Vertigo17.02.12.002; 04.04.01.003--
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