Medical Editor: John P. Cunha, DO, FACOEP
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy. Quartette is available in generic form. Common side effects of Quartette include:
- headaches,
- heavy/irregular vaginal bleeding,
- nausea,
- vomiting,
- acne,
- menstrual cramps,
- weight gain,
- mood changes,
- depression,
- anxiety/panic attack,
- migraines.
Take a dose of one Quartette tablet daily by mouth at the same time every day for 91 Days. Take tablets in the order directed on the Extended-Cycle Tablet Dispenser. Quartette may interact with phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, St. John's wort, atorvastatin, ascorbic acid, acetaminophen, itraconazole or ketoconazole, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, lamotrigine, thyroid hormone replacement therapy, and drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Quartette; it is not recommended for use during pregnancy. Breastfeeding is not recommended while using Quartette as it can decrease milk production. Small amounts of Quartette pass into breast milk. Other forms of contraception are recommended until the child is weaned.
Our Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) 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.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using birth control pills and call your doctor at once if you have:
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
- signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or redness in an arm or leg;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
- swelling in your hands, ankles, or feet;
- changes in the pattern or severity of migraine headaches;
- a breast lump; or
- symptoms of depression--sleep problems, weakness, tired feeling, mood changes.
Common side effects may include:
- mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
- breast tenderness or swelling, nipple discharge;
- freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge; or
- changes in your menstrual periods, decreased sex drive.
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.
Read the entire detailed patient monograph for Quartette (Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol)
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 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 safety data described below are from a 12-month, US, open-label study, which enrolled women aged 18-40, of whom 3,597 took at least one dose of Quartette (2,661 woman-years of exposure) [see Clinical Studies].
Adverse Reactions Leading To Study Discontinuation
13.3% 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 heavy/irregular bleeding (5.0%), mood swings/alteration/affect lability (1.4%), headaches/migraines (1.3%), weight increased (1.3%) and acne (1.0%).
Common Adverse Reactions (≥2% Of Women)
headaches (12.2%), heavy/irregular vaginal bleeding (9.7%), nausea/vomiting (8.8%), acne (5.4%), dysmenorrhea (5.4%), weight increased (4.6%), mood changes (depression, depressed mood, crying, major depression, affective disorder, depression suicidal, dysthymic disorder) (2.9%), anxiety/panic attack (2.4%), breast tenderness/pain/discomfort (2.2%), migraine (2.0%).
Serious Adverse Reactions (≥2 Women)
Abortion Spontaneous, Suicide Attempt, Cholecystitis/ Cholelithiasis, Deep Vein Thrombosis, Ectopic Pregnancy.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of other extended-cycle COCs containing levonorgestrel and ethinyl estradiol. Because these reactions are 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.
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 Quartette (Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol)
© Quartette Patient Information is supplied by Cerner Multum, Inc. and Quartette Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.