FDA label f2a0c59a-f966-50f8-e053-2995a90a9cc1

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
10727aa8-a03e-4b61-9a80-a024cb4a2d28
SPL ID
f2a0c59a-f966-50f8-e053-2995a90a9cc1
Version
5
Effective date
2023-01-19
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:52:19

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS SECTION Administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of CNS toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo, paresis, or dysarthria. The toxicity of cycloserine is closely related to excessive blood levels (above 30 μg/mL), as determined by high dosage or inadequate renal clearance. The ratio of toxic dose to effective dose in tuberculosis is small. The risk of convulsions is increased in chronic alcoholics. Patients should be monitored by hematologic, renal excretion, blood level, and liver function studies.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS SECTION Most adverse reactions occurring during therapy with cycloserine involve the nervous system or are manifestations of drug hypersensitivity. The following side effects have been observed in patients receiving cycloserine: Nervous system symptoms (which appear to be related to higher dosages of the drug, i.e., more than 500 mg daily) Convulsions Drowsiness and somnolence Headache Tremor Dysarthria Vertigo Confusion and disorientation with loss of memory Psychoses, possibly with suicidal tendencies Character changes Hyperirritability Aggression Paresis Hyperreflexia Paresthesia Major and minor (localized) clonic seizures Coma Cardiovascular Sudden development of congestive heart failure in patients receiving 1 to 1.5 g of cycloserine daily has been reported Allergy (apparently not related to dosage) Skin rash Miscellaneous Elevated serum transaminase, especially in patients with preexisting liver disease

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.