Medical Editor: John P. Cunha, DO, FACOEP
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:
- headache,
- heavy menstrual periods,
- abnormally heavy periods,
- nausea,
- menstrual cramps,
- acne,
- migraine,
- breast tenderness,
- weight gain, and
- depression
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 AnswerSIDE EFFECTS
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
- Serious cardiovascular events and stroke [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 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)
