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Quasense

Last reviewed on RxList: 2/28/2019
Quasense Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/28/2019

Quasense (levonorgestrel and ethinyl estradiol tablets) is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy. Quasense is available in generic form. Common side effects of Quasense include:

The dose of Quasense is one tablet daily by mouth at the same time every day for 91 days. Quasense may interact with phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John's wort, colesevelam, ascorbic acid (vitamin C), acetaminophen, azole antifungals, grapefruit juice, HIV or HCV protease inhibitors, cyclosporine, prednisolone, theophylline, tizanidine, clofibric acid, morphine, salicylic acid, temazepam, lamotrigine, thyroid hormone replacement therapy, and HCV drug combinations containing ombitasvir/paritaprevir/ritonavir. Tell your doctor all medications and supplements you use. Combined oral contraceptives (COC) such as Quasense are not intended for use during pregnancy. Quasense may decrease milk production in lactating women. Other methods of contraception are recommended. Consult your doctor before breastfeeding.

Our Quasense (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.

QUESTION

Which of the following are methods for contraception? See Answer
Quasense Professional Information

SIDE EFFECTS

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

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 QUASENSE was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 456 took at least one dose of QUASENSE (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 QUASENSE 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 QUASENSE. 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 Quasense (Levonorgestrel and Ethinyl Estradiol Tablets)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Related Resources for Quasense

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

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