May 29, 2017
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Seasonale

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Seasonale




Seasonale Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/30/2016

Seasonale (levonorgestrel, ethinyl estradiol) extended-cycle is a combination of female hormones used as contraception to prevent pregnancy. Seasonale is available in generic form. Common side effects of Seasonale include:

  • nausea (especially when you first start taking Seasonale),
  • vomiting,
  • headache,
  • stomach cramping,
  • bloating,
  • dizziness,
  • vaginal discomfort/irritation/itching,
  • increased vaginal fluids or 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,
  • problems with contact lenses,
  • swelling of the ankles or feet (fluid retention), or
  • decreased sex drive.

Acne may improve or get worse. Vaginal bleeding between menstrual periods (spotting) may occur, especially during the first few months of use of Seasonale. Tell your doctor if you have serious side effects of Seasonale including:

  • lumps in the breast,
  • mental/mood changes (such as new or worsening depression),
  • severe stomach or abdominal pain,
  • dark urine, or
  • yellowing eyes or skin.

The dosage of Seasonale is one pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets. Seasonale may interact with acetaminophen, ascorbic acid (vitamin C), phenylbutazone, prednisolone, theophylline, cyclosporine, St. John's wort, antibiotics, seizure medicines, barbiturates, or HIV medicines. Tell your doctor all medications and supplements you use. Seasonale must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, consult your doctor about birth control, and find out when it is safe use birth control containing estrogen, such as this medication. This medication passes into breast milk. This may affect how much milk you make and may have undesirable effects on the nursing infant. Consult your doctor before breastfeeding.

Our Seasonale (levonorgestrel, 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Seasonale in Detail - Patient Information: Side Effects

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 Seasonale (Levonorgestrel, Ethinyl Estradiol)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Seasonale Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

You should not have your period during the 3 months that you are taking the active pills. Instead, you will have your period once every 3 months, during the week that you are taking the inactive pills. This effect is normal with this product. However, if you do not have your period while taking the inactive pills, contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Seasonale (Levonorgestrel, Ethinyl Estradiol)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Seasonale FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 clinical practice.

The clinical trial that evaluated the safety and efficacy of SEASONALE was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18-40, of whom 456 took at least one dose of SEASONALE (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 SEASONALE 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 SEASONALE. 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 Seasonale (Levonorgestrel, Ethinyl Estradiol)

Seasonale - User Reviews

Seasonale User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Seasonale sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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