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)
Frequent bowel movements07.02.04.0020.000466%Not Available
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal pain07.01.05.005--
Headache17.14.01.0010.002097%
Hypersensitivity10.01.03.0030.000466%
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Leukocytosis01.02.01.002--
Lip swelling07.05.04.005; 23.04.01.007; 10.01.05.0050.000466%Not Available
Loss of consciousness17.02.04.004--Not Available
Lung disorder22.02.07.001--Not Available
Malaise08.01.01.003--
Metrorrhagia21.01.01.006--Not Available
Muscle spasms15.05.03.0040.000466%
Myalgia15.05.02.001--
Nausea07.01.07.0010.004427%
Oedema08.01.07.006; 14.05.06.010--Not Available
Pain08.01.08.004--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.0320.000699%Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pruritus23.03.12.0010.001398%
Rash23.03.13.0010.001398%Not Available
Rash pruritic23.03.12.0020.000699%Not Available
Renal pain20.02.03.003--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
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