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 For the treatment of diarrhea in adults and children caused by the protozoa Giardia lamblia, and for the treatment of diarrhea in children caused by the protozoan, Cryptosporidium parvum [FDA label]. 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 approved; investigational; vet_approved
ATC Code P01AX11
DrugBank ID DB00507
KEGG ID D02486
MeSH ID C041747
PubChem ID 41684
TTD Drug ID D08EBN
NDC Product Code 11014-0127; 43386-405; 64980-526; 11014-0128; 69766-077; 11014-0178; 11014-0384; 69575-4038; 67546-111; 67546-212; 68022-7020; 70966-0013; 57741-3800; 51927-5207; 71052-232
UNII SOA12P041N
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
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)
Frequent bowel movements07.02.04.0020.000482%-
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal pain07.01.05.005--
Headache17.14.01.0010.002409%
Hypersensitivity10.01.03.0030.000482%
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023; 23.03.03.081---
Increased appetite08.01.09.027; 14.03.01.003---
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Insomnia17.15.03.002; 19.02.01.0020.000963%
Leukocytosis01.02.01.002--
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.0070.000482%-
Loss of consciousness17.02.04.004---
Lung disorder22.02.07.001---
Malaise08.01.01.003--
Muscle spasms15.05.03.0040.000723%
Myalgia15.05.02.001--
Nausea07.01.07.0010.005129%
Oedema08.01.07.006; 14.05.06.010---
Pain08.01.08.004--
Pallor08.01.03.032; 23.03.03.031; 24.03.04.0010.000553%-
Pelvic pain07.01.06.012; 20.02.03.007; 21.10.01.001--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pruritus23.03.12.0010.001927%
Rash23.03.13.0010.001686%-
Rash erythematous23.03.13.0290.000312%-
Rash pruritic23.03.13.0300.000963%-
Renal pain20.02.03.003---
Rhinitis11.01.13.004; 22.07.03.006--
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ADReCS-Target
Drug Name ADR Term Target
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