Isoniazid
Isoniazid, Rifamate, Rifater (isoniazid) is a small molecule pharmaceutical. Isoniazid was first approved as Nydrazid on 1982-01-01. It is used to treat mycobacterium infections and tuberculosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
Trade Name
FDA
EMA
Isoniazid (discontinued: Dow-isoniazid, Hyzyd, Inh, Isoniazid, Laniazid, Nydrazid, Rimifon, Stanozide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isoniazid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NYDRAZID | Bristol Myers Squibb | N-008392 DISCN | 1982-01-01 | 1 products |
| ISONIAZID | Epic Pharma | N-008678 DISCN | 1982-01-01 | 2 products, RLD |
| ISONIAZID | Eli Lilly | N-008499 DISCN | 1982-01-01 | 2 products |
| ISONIAZID | Panray Corporation | N-008428 DISCN | 1982-01-01 | 3 products |
| RIMIFON | Roche | N-008420 DISCN | 1982-01-01 | 3 products |
| NYDRAZID | Sandoz | N-008662 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| albuterol sulfate inhalation solution | ANDA | 2024-12-17 |
| albuterol sulfate inhalation solution, 0.5% | ANDA | 2025-03-24 |
| ammonia | unapproved drug other | 2021-09-02 |
| ammonia inhalant | unapproved drug other | 2020-04-27 |
| ammonia inhalants | unapproved drug other | 2024-10-28 |
| amoray premium vaporizing inhaler | OTC monograph final | 2016-03-31 |
| arformoterol tartrate inhalation | ANDA | 2023-01-24 |
| arformoterol tartrate inhalation solution | ANDA | 2025-02-11 |
| bardown smelling salts | unapproved drug other | 2025-04-16 |
| berinert | Biologic Licensing Application | 2009-11-10 |
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Indications
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Agency Specific
FDA
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Patent Expiration
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ATC Codes
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AC: Hydrazides for tuberculosis treatment
— J04AC01: Isoniazid
— J04AC51: Isoniazid, combinations
— J04AM: Combinations of drugs for treatment of tuberculosis
— J04AM01: Streptomycin and isoniazid
— J04AM02: Rifampicin and isoniazid
— J04AM03: Ethambutol and isoniazid
— J04AM04: Thioacetazone and isoniazid
— J04AM05: Rifampicin, pyrazinamide and isoniazid
— J04AM06: Rifampicin, pyrazinamide, ethambutol and isoniazid
— J04AM07: Rifampicin, ethambutol and isoniazid
— J04AM08: Isoniazid, sulfamethoxazole, trimethoprim and pyridoxine
HCPCS
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Clinical
Clinical Trials
380 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | 4 | 1 | — | — | 5 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 2 | 1 | — | — | 3 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | 1 | — | — | 1 |
| Hemophilia b | D002836 | — | D67 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Latent tuberculosis | D055985 | — | Z22.7 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Isoniazid |
| INN | isoniazid |
| Description | Isoniazide is a carbohydrazide obtained by formal condensation between pyridine-4-carboxylic acid and hydrazine. It has a role as an antitubercular agent and a drug allergen. It is functionally related to an isonicotinic acid. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NNC(=O)c1ccncc1 |
Identifiers
| PDB | — |
| CAS-ID | 54-85-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL64 |
| ChEBI ID | 6030 |
| PubChem CID | 3767 |
| DrugBank | DB00951 |
| UNII ID | V83O1VOZ8L (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Isoniazid
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 58,305 documents
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Safety
Black-box Warning
Black-box warning for: Feiba, Isoniazid, Provocholine, Provocholine provocholine inhalation solution
Adverse Events
Top Adverse Reactions
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46,962 adverse events reported
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