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
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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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EMA
Brand Name | Status | Last Update |
|---|---|---|
| albuterol sulfate inhalation solution | ANDA | 2025-06-19 |
| 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 | 2025-08-11 |
| amoray premium vaporizing inhaler | OTC monograph final | 2016-03-31 |
| arformoterol tartrate inhalation | ANDA | 2025-07-15 |
| arformoterol tartrate inhalation solution | ANDA | 2025-06-19 |
| bardown smelling salts | unapproved drug other | 2025-04-16 |
| berinert | Biologic Licensing Application | 2009-11-10 |
Show 43 more
Indications
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Agency Specific
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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
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Clinical
Clinical Trials
390 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 32 | 78 | 64 | 32 | 70 | 252 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 6 | 42 | 26 | 7 | 12 | 83 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 5 | 14 | 17 | 10 | 16 | 57 |
| Latent tuberculosis | D055985 | — | Z22.7 | 11 | 5 | 15 | 11 | 9 | 47 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 3 | 2 | 8 | 5 | 10 | 27 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | 1 | 7 | 10 | 2 | 8 | 25 |
| Hereditary angioedemas | D054179 | EFO_0004131 | — | 1 | 7 | 7 | 3 | 4 | 19 |
| Hiv | D006678 | — | O98.7 | 3 | 3 | 6 | 1 | 5 | 17 |
| Infections | D007239 | EFO_0000544 | — | 2 | 3 | 7 | 3 | 3 | 17 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | 1 | 4 | 6 | 1 | 3 | 13 |
Show 37 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningeal tuberculosis | D014390 | — | A17.0 | 1 | 7 | 3 | — | 2 | 11 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | 1 | 6 | — | — | 8 |
| Aids-related opportunistic infections | D017088 | — | — | 1 | — | 1 | — | 5 | 7 |
| Meningitis | D008581 | EFO_0000584 | G03 | — | 2 | 1 | — | 2 | 5 |
| Uveitis | D014605 | EFO_1001231 | H20.9 | — | 1 | 1 | — | 1 | 3 |
| Respiratory tract infections | D012141 | — | J06.9 | 1 | 1 | 1 | — | 1 | 3 |
| Extensively drug-resistant tuberculosis | D054908 | — | — | — | 1 | 2 | — | 1 | 3 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 3 | 1 | — | — | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | 1 | — | 1 | 3 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | 1 | — | 1 | 2 |
Show 22 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aids-related complex | D000386 | EFO_0007137 | B20 | — | 1 | — | — | 2 | 3 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | 1 | 2 |
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | 2 | — | — | — | 2 |
| Hemoglobinuria | D006456 | — | R82.3 | — | 2 | — | — | — | 2 |
| Gram-positive bacterial infections | D016908 | — | — | 1 | 1 | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | — | 1 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 1 | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 1 | — | — | — | 1 |
| Craniocerebral trauma | D006259 | — | S00 | — | 1 | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | — | 1 | — | — | — | 1 |
Show 7 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | 1 | 7 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | 1 | — | — | — | 2 | 3 |
| Breast feeding | D001942 | — | — | 1 | — | — | — | 1 | 2 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | — | — | — | — | 3 | 3 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | — | — | — | 1 | 1 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | — | — | — | 1 | 1 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | — | 1 | 1 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 1 | 1 |
| Cholecystitis | D002764 | — | K81 | — | — | — | — | 1 | 1 |
| Acalculous cholecystitis | D042101 | EFO_1000790 | — | — | — | — | — | 1 | 1 |
Show 32 more
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) |
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Estimated US medical usage
Isoniazid
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Trends
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Safety
Black-box Warning
Black-box warning for: Feiba, Provocholine, Provocholine provocholine inhalation solution
Adverse Events
Top Adverse Reactions
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50,153 adverse events reported
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