Medical Editor: John P. Cunha, DO, FACOEP
What Is Seasonale?
What Are Side Effects of Seasonale?
Common side effects of Seasonale include:
- nausea (especially when you first start taking Seasonale),
- stomach cramping,
- 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.
Dosage for Seasonale
The dosage of Seasonale is one pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets.
What Drugs, Substances, or Supplements Interact with Seasonale?
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 During Pregnancy or Breastfeeding
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.
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.
Read the entire detailed patient monograph for Seasonale (Levonorgestrel, Ethinyl Estradiol)
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
- Breast tenderness
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%).
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
Read the entire FDA prescribing information for Seasonale (Levonorgestrel, Ethinyl Estradiol)
© Seasonale Patient Information is supplied by Cerner Multum, Inc. and Seasonale Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.