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Jolessa

Last reviewed on RxList: 3/26/2020
Jolessa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Jolessa?

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

What Are Side Effects of Jolessa?

Side effects of Jolessa include:

Dosage for Jolessa

The dose of Jolessa is one tablet taken once a day by mouth at the same time every day for 91 days. To achieve maximum contraceptive effectiveness, Jolessa should be taken exactly as directed and at intervals not exceeding 24 hours.

Jolessa In Children

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

What Drugs, Substances, or Supplements Interact with Jolessa?

Jolessa may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Jolessa During Pregnancy and Breastfeeding

Jolessa is intended to prevent pregnancy and is not indicated for use during pregnancy. There is little or no increased risk of birth defects in women who inadvertently use combined oral contraceptive (COCs) during early pregnancy. Women who do not breastfeed may start COCs no earlier than four to six weeks postpartum. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. Estrogen-containing COCs such as Jolessa can reduce milk production in breastfeeding mothers. Nursing mothers are advised when possible to use other forms of contraception until they have weaned their children. Consult your doctor before breastfeeding.

Additional Information

Our Jolessa (levonorgestrel/ethinyl estradiol kit) 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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Jolessa Professional Information

SIDE EFFECTS

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

  • Serious cardiovascular events and stroke [see BOX 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 clinical practice.

The clinical trial that evaluated the safety and efficacy of JOLESSA was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 456 took at least one dose of JOLESSA (345.14 woman-years of exposure) [see Clinical Studies].

Adverse Reactions Leading to Study Discontinuation: 14.9% of the women discontinued from the clinical trial due to an adverse reaction; the most common adverse reactions (≥ 1% of women) leading to discontinuation in the JOLESSA group were menorrhagia (5.7%), mood swings (1.9%), weight/appetite increase (1.5%), and acne (1.3%).

Common Adverse Reactions (≥ 2% of Women): headache (20.6%), menorrhagia (11.6%), nausea (7.5%), dysmenorrhea (5.7%), acne (4.6%), migraine (4.4%), breast tenderness (3.5%), weight increased (3.1%), and depression (2.1%).

Serious Adverse Reactions: pulmonary embolus, cholecystitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of JOLESSA. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or 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 disorder: hypersensitivity reactions, including itching, rash, and angioedema

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

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis, pulmonary embolism, pulmonary thrombosis

Read the entire FDA prescribing information for Jolessa (Levonorgestrel/Ethinyl Estradiol Tablets)

QUESTION

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

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

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