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Seasonique

Last reviewed on RxList: 8/30/2010
Seasonique Side Effects Center

Last reviewed on RxList 11/07/2016

Seasonique (levonorgestrel and ethinyl estradiol) is a combination of forms of progesterone and estrogen, female hormones, used as a contraceptive to prevent pregnancy. Seasonique is available in generic form. Common side effects of Seasonique include:

  • nausea (especially when you first start taking Seasonique),
  • vomiting,
  • headache,
  • stomach cramping,
  • bloating,
  • dizziness,
  • vaginal discomfort/irritation/itching,
  • increased vaginal fluids/discharge,
  • breast tenderness/enlargement/swelling,
  • nipple discharge,
  • freckles or darkening of facial skin,
  • increased hair growth,
  • loss of scalp hair,
  • changes in weight or appetite,
  • swelling of the ankles/feet (fluid retention),
  • problems with contact lenses,
  • changes in your menstrual periods, or
  • decreased sex drive.

Acne may improve or get worse. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of using Seasonique.

The dosage of Seasonique 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. Seasonique must be taken as directed and at intervals not exceeding 24 hours. Seasonique may interact with antibiotics, barbiturates, seizure or pain medicines, or rifampin. Tell your doctor all medications you are taking. Seasonique must not be used during pregnancy. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication. This medication passes into breast milk. This may affect how much milk you make and may also have undesirable effects on the nursing infant. Consult your doctor before breastfeeding.

Our Seasonique (levonorgestrel 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.

Seasonique Consumer Information

Get emergency medical help if you have any of these 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 a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden and severe headache, confusion, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • a change in the pattern or severity of migraine headaches;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious 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 Seasonique (Levonorgestrel, Ethinyl Estradiol)

Seasonique 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:

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 Seasonique (levonorgestrel, ethinyl estradiol) 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 Seasonique (levonorgestrel, ethinyl estradiol) .

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 Seasonique (levonorgestrel, ethinyl estradiol) . 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 Seasonique (Levonorgestrel, Ethinyl Estradiol)

Related Resources for Seasonique

Read the Seasonique User Reviews »

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

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