Tyblume Side Effects Center

Last updated on RxList: 5/31/2022
Tyblume Side Effects Center

What Is Tyblume?

Tyblume (levonorgestrel and ethinyl estradiol) is a combination of female hormones indicated for use by females of reproductive potential to prevent pregnancy.

What Are Side Effects of Tyblume?

Side effects of Tyblume include:

Dosage for Tyblume

The dose of Tyblume is one tablet taken daily for 28 consecutive days: one white active tablet daily during the first 21 consecutive days, followed by one peach inactive tablet daily during the 7 following days.

Tyblume In Children

The safety and effectiveness of Tyblume have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of Tyblume before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Tyblume?

Tyblume may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Tyblume During Pregnancy and Breastfeeding

There is no use for contraception in pregnancy; therefore, Tyblume should be discontinued during pregnancy. Tyblume passes into breast milk and may decrease milk production. Breastfeeding is not recommended while using Tyblume.

Additional Information

Our Tyblume (levonorgestrel and ethinyl estradiol) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Tyblume Professional Information


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

  • Serious cardiovascular events [see BOX WARNING and WARNINGS AND PRECAUTIONS]
  • Vascular events [see WARNINGS AND PRECAUTIONS]
  • Liver disease [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Gallbladder disease [see WARNINGS AND PRECAUTIONS]
  • Adverse carbohydrate and lipid metabolic effects [see WARNINGS AND PRECAUTIONS]
  • Bleeding irregularities and amenorrhea [see WARNINGS AND PRECAUTIONS]
  • Cervical cancer [see WARNINGS AND PRECAUTIONS]
  • Effect on binding globulins [see WARNINGS AND PRECAUTIONS]
  • Hereditary angioedema [see WARNINGS AND PRECAUTIONS]
  • Risk of liver enzyme elevations with concomitant hepatitis C treatment [see WARNINGS AND PRECAUTIONS]

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 [see WARNINGS AND PRECAUTIONS]

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

Read the entire FDA prescribing information for Tyblume (Levonorgestrel and Ethinyl Estradiol Tablets)


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© Tyblume Patient Information is supplied by Cerner Multum, Inc. and Tyblume Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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