Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nitazoxanide
Drug ID BADD_D01571
Description Nitazoxanide belongs to the class of drugs known as _thiazolides_. Nitazoxanide (NTZ) is a broad-spectrum anti-infective drug that markedly modulates the survival, growth, and proliferation of a range of extracellular and intracellular protozoa, helminths, anaerobic and microaerophilic bacteria, in addition to viruses. This drug is effective in the treatment of gastrointestinal infections including Cryptosporidium parvum or Giardia lamblia in healthy subjects. It is generally well tolerated. Nitazoxanide is a first-line, standard treatment for illness caused by C. parvum or G. lamblia infection in healthy (not immunosuppressed) adults and children and may also be considered in the treatment of illnesses caused by other protozoa or helminths [A31976]. Recently, this drug has been studied as a broad-spectrum antiviral agent due to its ability to inhibit the replication of several RNA and DNA viruses [A31977].
Indications and Usage Nitazoxanide has not been shown to be superior to placebo medication for the management of diarrhea caused by Cryptosporidium parvum in patients with HIV/immunodeficiency [FDA label, A31973, A31976].
Marketing Status Prescription
ATC Code P01AX11
DrugBank ID DB00507
KEGG ID D02486
MeSH ID C041747
PubChem ID 41684
TTD Drug ID D08EBN
NDC Product Code 57741-3800; 70966-0013; 11014-0128; 72969-103; 11014-0384; 69575-4038; 68022-7020; 64980-526; 11014-0127; 69766-077; 67546-212; 11014-0178; 71052-232; 67546-111; 43386-405
Synonyms nitazoxanide | 2-(Acetolyloxy)-N-(5-nitro-2-thiazolyl)benzamide | Taenitaz | Colufase | Daxon | Heliton | NTZ | Alinia | Cryptaz
Chemical Information
Molecular Formula C12H9N3O5S
CAS Registry Number 55981-09-4
SMILES CC(=O)OC1=CC=CC=C1C(=O)NC2=NC=C(S2)[N+](=O)[O-]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.001165%Not Available
Abdominal distension07.01.04.0010.000699%
Abdominal pain07.01.05.0020.002330%
Abdominal pain upper07.01.05.0030.003495%
Alanine aminotransferase increased13.03.01.003--
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaemia01.03.02.001--
Arthralgia15.01.02.0010.000932%
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood creatinine increased13.13.01.004--
Body temperature increased13.15.01.001--Not Available
Chills15.05.03.016; 08.01.09.001--
Chromaturia20.02.01.0020.002563%
Constipation07.02.02.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.0010.004194%
Discomfort08.01.08.003--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.001165%
Dry mouth07.06.01.002--
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.0020.000699%
Ear pain04.03.01.003--
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.0010.000466%Not Available
Fatigue08.01.01.0020.001631%
Feeling abnormal08.01.09.0140.000466%Not Available
Flatulence07.01.04.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.0250.000466%
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