Chlorthalidone
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Chlorthalidone
- Generic name
- CHLORTHALIDONE
- Manufacturer
- Mylan Institutional Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 193c85ba-43c2-4be2-82cf-7b394a83390e
- SPL ID
- 48d2cfb7-9e20-e6da-e063-6294a90a9254
- Version
- 8
- Effective date
- 2026-01-20
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:25:48
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 086831 | derived:openfda.application_number |
| application number | ANDA086831 | openfda.application_number | |
| brand name | Chlorthalidone | openfda.brand_name | |
| generic name | CHLORTHALIDONE | openfda.generic_name | |
| manufacturer name | Mylan Institutional Inc. | openfda.manufacturer_name | |
| ndc | package | 51079-058-20 | openfda.package_ndc |
| ndc | package | 51079-058-01 | openfda.package_ndc |
| ndc | product | 51079-058 | openfda.product_ndc |
| ndc11 | package | 51079005801 | derived:openfda.package_ndc |
| ndc11 | package | 51079005820 | derived:openfda.package_ndc |
| rxcui | 197499 | openfda.rxcui | |
| spl id | 48d2cfb7-9e20-e6da-e063-6294a90a9254 | id | |
| spl set id | 193c85ba-43c2-4be2-82cf-7b394a83390e | set_id | |
| unii | Q0MQD1073Q | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Chlorthalidone should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to chlorthalidone. However, systemic lupus erythematosus has not been reported following chlorthalidone administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis. Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia. Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia. Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis). Cardiovascular Reactions: orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics. Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence. Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.