FDA label 7cb97fc9-59d3-3271-e053-2a91aa0afa5c

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
7cb97fc9-59d2-3271-e053-2a91aa0afa5c
SPL ID
7cb97fc9-59d3-3271-e053-2a91aa0afa5c
Version
1
Effective date
2018-12-11
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:48

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings/Precautions: Smokers over 35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Nursing mothers: not recommended Contraindications Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X). Interactions Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels Adverse Reactions: Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.

Reported adverse events (FAERS/openFDA)#

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