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  • Generic Name: levonorgestrel and ethinyl estradiol tablets
  • Brand Name: Tyblume
  • Drug Class: Contraceptives, Oral
Last updated on MDtodate: 10/12/2022


The following serious adverse reactions with the use of CHCs are discussed elsewhere in labeling:

  • Serious cardiovascular events [
  • Vascular events
  • Liver disease
  • Hypertension
  • Gallbladder disease
  • Adverse carbohydrate and lipid metabolic effects
  • Headache
  • Bleeding irregularities and amenorrhea
  • Depression
  • Cervical cancer
  • Effect on binding globulins
  • Hereditary angioedema
  • Chloasma
  • Risk of liver enzyme elevations with concomitant hepatitis C treatment

The following adverse reactions associated with the use of oral CHCs were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.

Additional adverse reactions that have been reported include the following:

Eye disorder: intolerance to contact lenses, steepening of corneal curvature

Gastrointestinal disorders: Abdominal bloating, vomiting

General disorders and administration site condition:Edema, fluid retention

Hepatobiliary disorders: Cholestatic jaundice

Psychiatric disorders: Change in libido, mood changes

Reproductive system and breast disorders:Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding

Skin and subcutaneous tissue disorders: Acne, melasma

Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins.



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