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Camrese

Last reviewed on RxList: 3/25/2020
Camrese Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Camrese?

Camrese (levonorgestrel/ethinyl estradiol and ethinyl estradiol kit) is a combined oral contraceptive (COC) indicated for use by women to prevent pregnancy.

What Are Side Effects of Camrese?

Side effects of Camrese include:

Dosage for Camrese

The dose of Camrese is one tablet taken by mouth at the same time every day. The dosage of Camrese is one light blue-green tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days.

Camrese In Children

Safety and efficacy of Camrese have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of Camrese before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Camrese?

Camrese may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Camrese During Pregnancy and Breastfeeding

Our Camrese (levonorgestrel/ethinyl estradiol and ethinyl estradiol kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Additional Information

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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Camrese Professional Information

SIDE EFFECTS

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

  • Serious cardiovascular events and smoking [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Vascular events [see WARNINGS AND PRECAUTIONS]
  • Liver disease [see WARNINGS AND PRECAUTIONS]

Adverse reactions commonly reported by COC users are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The clinical trial that evaluated the safety and efficacy of CAMRESE was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 1,006 took at least one dose of CAMRESE.

Adverse Reactions Leading To Study Discontinuation: 16.3% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation were irregular and/or heavy uterine bleeding (5.9%), weight gain (2.4%), mood changes (1.5%), and acne (1.0%).

Common Treatment-Emergent Adverse Reactions (≥ 5% of women): irregular and/or heavy uterine bleeding (17%), weight gain (5%), acne (5%).

Serious Adverse Reactions: migraine, cholecystitis, cholelithiasis, pancreatitis, abdominal pain, and major depressive disorder.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CAMRESE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency of establish a causal relationship to drug exposure.

Gastrointestinal disorders: abdominal distension, vomiting

General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain

Immune system disorders: hypersensitivity reaction

Investigations: blood pressure increased

Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity

Nervous system disorders: dizziness, loss of consciousness

Psychiatric disorders: insomnia

Reproductive and breast disorders: dysmenorrhea

Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis

Read the entire FDA prescribing information for Camrese (Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol Kit)

QUESTION

Which of the following are methods for contraception? See Answer
Related Resources for Camrese

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

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