FDA label e30ca03c-061f-4ec3-9637-545c9472fe88

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID
c5e29db6-e6a9-457c-8d65-9c4196555fb0
SPL ID
e30ca03c-061f-4ec3-9637-545c9472fe88
Version
2
Effective date
2011-06-15
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:41

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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, because 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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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 diarrhea gastric irritation constipation nausea jaundice (intrahepatic vomiting cholestatic jaundice) cramping pancreatitis Central Nervous System Reactions: dizziness headache vertigo xanthopsia paresthesias Hematologic Reactions: leukopenia thrombocytopenia agranulocytosis aplastic anemia Dermatologic-Hypersensitivity Reactions: purpura necrotizing angiitis photosensitivity (vasculitis) rash (cutaneous vasculitis) urticaria Lyell’s syndrome (toxic epidermal necrolysis) Cardiovascular Reaction: Orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates or narcotics. Other Adverse Reactions: Hyperglycemia glycosuria weakness Hyperuricemia restlessness muscle spasm 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.