Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Metronidazole
Drug ID BADD_D01449
Description Metronidazole is a commonly used antibiotic, belonging to the nitroimidazole class of antibiotics.[L3754] It is frequently used to treat gastrointestinal infections as well as trichomoniasis and giardiasis, and amebiasis which are parasitic infections.[A181036,A18039] Metronidazole has been used as an antibiotic for several decades[L7429], with added antiparasitic properties that set it apart from many other antibacterial drugs, allowing it to treat a wide variety of infections. It is available in capsule form, tablet form, and topical form, and suppository preparations for the treatment of various infections.
Indications and Usage Metronidazole is indicated for the treatment of confirmed trichomoniasis caused by Trichomonas vaginalis (except for in the first trimester of pregnancy) and the patient's sexual partners, bacterial vaginosis[L7432], certain types of amebiasis, and various anaerobic infections.[A181057] The above anaerobic infections may occur on the skin and skin structures, the abdomen, the heart, reproductive organs, central nervous system, and the respiratory system. Some may also be present in the bloodstream in cases of septicemia. Common infections treated by metronidazole are Bacteroides species infections, Clostridium infections, and Fusobacterium infections, as well as Peptococcus and Peptostreptococcus infections.[L3754] It is also used off-label in the treatment of Crohn's disease and rosacea, as a prophylactic agent after surgery[A181039], and in the treatment of Helicobacter pylori infection.[A181045] It has also been studied in the prevention of preterm births and to treat periodontal disease.[A1391,A181078]
Marketing Status approved
ATC Code A01AB17; D06BX01; G01AF01; J01XD01; P01AB01
DrugBank ID DB00916
KEGG ID D00409
MeSH ID D008795
PubChem ID 4173
TTD Drug ID D0A2ZX
NDC Product Code 80830-2465; 0904-7156; 23155-652; 50090-0211; 50090-4809; 50111-333; 51407-372; 62332-018; 66993-962; 67296-1366; 68071-2549; 0409-0152; 68180-684; 68682-455; 69292-208; 70518-0013; 70518-0539; 70518-2663; 70518-3042; 70771-1834; 71335-1775; 46708-428; 46708-429; 0187-5202; 50090-0212; 50090-0214; 50090-5691; 51407-376; 60687-550; 63629-1388; 63629-8731; 68788-7815; 70518-3265; 72578-008; 72578-129; 0713-0633; 0904-7126; 38779-0146; 62991-1685; 25021-131; 29300-227; 45802-139; 46708-435; 50090-5687; 51672-4164; 0264-5535; 55154-8190; 55700-909; 0299-3836; 0338-9541; 63187-035; 63629-7940; 64380-780; 64980-235; 66993-936; 68071-2806; 70518-1240; 70518-3110; 71335-1681; 54348-740; 60687-526; 62332-016; 63187-827; 66993-960; 68071-2809; 68071-5283; 68462-184; 70518-2305; 70518-2814; 70934-813; 71209-063; 71335-1609; 71335-1703; 71335-1838; 72578-007; 16714-557; 45865-717; 50090-5787; 51655-441; 55700-298; 61919-032; 62332-017; 67457-697; 68001-364; 68180-683; 72789-007; 72789-195; 15955-388; 16571-664; 0115-1474; 43063-738; 0168-0383; 50090-5688; 50268-534; 0245-0860; 53002-2478; 58118-0527; 0299-3820; 0338-1055; 64980-236; 65862-694; 67296-1283; 0404-9991; 68071-2251; 0409-7811; 68788-8230; 70518-0090; 70882-131; 0781-7077; 0781-7080; 51927-1449; 53747-007; 60592-427; 68981-034; 23155-651; 53002-2470; 0299-3838; 60760-539; 61919-499; 63629-1386; 63629-7916; 64380-779; 68788-7955; 70518-1536; 70518-3073; 71335-0358; 71335-1922; 0713-0575; 0713-0637; 49452-4726; 49964-0002; 51552-0038; 43063-719; 50090-5768; 50111-334; 50268-535; 51672-4116; 52584-811; 53002-7341; 63629-8680; 68083-373; 69043-005; 70518-0797; 70882-130; 71335-0858; 72789-011; 0642-7466; 73473-303; 0713-0574; 82982-039; 0395-8115; 15955-389; 21922-039; 47335-993; 50090-0213; 50090-5249; 51655-974; 54348-745; 60760-336; 67296-1747; 69043-004; 70518-0324; 70934-970; 71209-062; 72789-005; 16571-665; 29300-226; 46708-021; 53002-7340; 60760-664; 61919-363; 62332-630; 63187-511; 65862-695; 66993-961; 68001-365; 68071-2280; 68071-2288; 68071-2551; 68071-3039; 69292-207; 70518-0058; 70518-0088; 70518-1241; 70934-956; 0168-0275; 0168-0323; 50090-0201; 50090-2126; 51672-4215; 53002-2471; 0025-1942
UNII 140QMO216E
Synonyms Metronidazole | 2-Methyl-5-nitroimidazole-1-ethanol | 2 Methyl 5 nitroimidazole 1 ethanol | Satric | Trichazol | Trichopol | Trivazol | Metronidazole Phosphoester | Vagilen | Bayer 5360 | Metronidazole Phosphate | Danizol | Flagyl | Gineflavir | Metric | Metrodzhil | MetroGel | Metrogyl | Metronidazole Hydrochloride | Metronidazole Monohydrochloride | Clont
Chemical Information
Molecular Formula C6H9N3O3
CAS Registry Number 443-48-1
SMILES CC1=NC=C(N1CCO)[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)
Central nervous system lesion17.02.10.0110.000197%-
Systemic inflammatory response syndrome08.01.05.005; 10.02.01.008; 24.06.03.0080.000026%-
Enterocutaneous fistula07.11.05.005; 23.07.04.0170.000039%-
Conjunctival hyperaemia06.04.01.0040.000026%-
Oscillopsia06.02.06.0090.000066%-
Ear discomfort04.03.01.005---
Eye pruritus06.04.05.0060.000053%-
Ocular discomfort06.08.03.0080.000039%-
Lymphatic disorder01.09.01.003---
Oedematous pancreatitis07.18.01.0060.000026%-
Deafness bilateral04.02.01.0070.000118%-
Oral pruritus07.05.05.0020.000026%-
Musculoskeletal stiffness15.03.05.0270.000399%-
Musculoskeletal discomfort15.03.04.001---
Organ failure08.01.03.0410.000026%-
Allodynia17.02.07.0170.000026%-
Type IV hypersensitivity reaction10.01.03.0220.000207%-
Vanishing bile duct syndrome09.02.03.0030.000026%-
Skin burning sensation17.02.06.009; 23.03.03.0210.000244%-
Cerebral disorder17.02.10.0170.000039%-
Foetal death08.04.01.011; 18.01.02.0030.000026%
Haemorrhage24.07.01.0020.003555%-
Vulvovaginal pruritus21.08.02.004; 23.03.12.0090.000026%-
Peripheral sensorimotor neuropathy17.09.03.0090.000092%-
Gaze palsy06.05.02.014; 17.02.05.0440.000053%-
Loss of proprioception17.02.07.0190.000026%-
Hypoaesthesia oral07.05.05.003; 17.02.06.0210.000137%-
Paraesthesia oral07.05.05.035; 17.02.06.0080.000168%-
Cognitive disorder17.03.03.003; 19.21.02.0010.000144%
Toxic skin eruption10.01.01.008; 12.03.01.073; 23.03.05.0030.000092%-
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ADReCS-Target
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