Indications  

Seasonale is a combination hormone medication used for pregnancy prevention. It consists of two female hormones: progestin (levonorgestrel) and estrogen (ethinyl estradiol). 

Seasonale works by inhibiting ovulation (egg release), modifying the uterine lining to prevent pregnancy development, and altering cervical mucus to impede sperm entry. 

This oral contraceptive is a highly effective birth control method; however, it does not offer protection against the transmission of human immunodeficiency virus (HIV) and other sexually transmitted diseases, including acquired immunodeficiency syndrome (AIDS). 

Uses and Dosage 

Before taking Seasonale and every time you get a refill, carefully review its medication guide and patient information leaflet. Should you have any questions, seek advice from your doctor or pharmacist. 

Seasonale comes in an extended-cycle tablet dispenser containing a total of 84 active pills and 7 reminder pills.  

One pill must be taken for 91 consecutive days at the same designated time. A new packet should be started the day following consumption of the 91st tablet. 

Start taking Seasonale on the first Sunday after the start of your menstrual period. If your period begins on a Sunday, begin the medication on that day. 

For first-time users of Seasonale, an additional form of non-hormonal birth control (e.g., condoms, spermicide) is recommended for the initial 7 days to prevent pregnancy until the medication becomes effective. However, if you start on the first day of your period, there is no need for backup birth control during the first week. 

To maintain a regular cycle, the pills must be taken in a specific order. Trays 1 and 2 contain 28 pills each, while tray 3 holds 35 pills, including the 7 reminder pills. Menstruation is expected during the period of using these reminder pills. 

For optimal contraceptive effectiveness, take Seasonale exactly as directed, with intervals not exceeding 24 hours.  

Avoid skipping any doses. Missing pills, starting a new pack late, or taking the pill at a different time than usual increases the likelihood of pregnancy. 

For information regarding missed doses, refer to the product information leaflet. To prevent pregnancy, it may be necessary to utilize additional contraceptive methods like condoms or spermicide.  

Side Effects 

Listed below are the potential adverse effects of Seasonale. Tell your doctor right away if any of them last or worsen. 

Common Side Effects 

• Mild nausea (particularly during initial use), vomiting, bloating, or stomach cramps 
• Breast tenderness or swelling, nipple discharge 
• Freckles or darkening of facial skin, increased hair growth, or loss of scalp hair 
• Changes in weight or appetite 
• Contact lens issues 
• Vaginal itching or discharge 
• Changes in menstrual periods and decreased sex drive 

Serious Side Effects 

• Sudden numbness or weakness, especially on one side of the body 
• Sudden severe headache, slurred speech, vision, or balance problems 
• Sudden cough, wheezing, rapid breathing, coughing up blood 
• Pain, swelling, warmth, or redness in one or both legs 
• Chest pain or heaviness, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling 
• Change in the pattern or severity of migraine headaches 
• Nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes) 
• Swelling in hands, ankles, or feet 
• Breast lump 
• Symptoms of depression (sleep problems, weakness, tiredness, mood changes) 

Stop taking Seasonale and call your doctor right away if you encounter any of the serious side effects mentioned above. 

Allergic Reactions 

Although rare, a severe allergic reaction to Seasonale may occur. Seek immediate medical attention if you encounter any signs of an allergic response, such as: 

• Hives 
• Difficulty breathing 
• Face, lips, tongue, or throat swelling 

Not all side effects of Seasonale are included in this list. Tell your doctor if any unlisted effects occur. 

Cautions 

Before taking Seasonale, inform your doctor if you have any known allergies, particularly to: 

• Ethinyl estradiol 
• Levonorgestrel 
• Other estrogens or progestins 
• Other medications 

Consult your pharmacist for more information about Seasonale, as it may contain inactive ingredients that may cause allergic reactions or other complications. 

To ensure Seasonale is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Blood clots (e.g., in legs, eyes, lungs) 
• Blood clotting disorders (e.g., protein C or protein S deficiency) 
• High blood pressure 
• Abnormal breast exam 
• Cancer, especially endometrial or breast cancer 
• High cholesterol or triglyceride levels (blood fat) 
• Depression 
• Diabetes 
• Family or personal history of angioedema (a certain swelling disorder) 
• Gallbladder problems 
• Severe headaches/migraines 
• Heart problems (e.g., heart valve disease, irregular heartbeat, previous heart attack) 
• Jaundice during pregnancy or while using hormonal birth control 
• Kidney disease 
• Liver disease, including tumors 
• Stroke 
• Swelling (edema) 
• Thyroid problems 
• Unexplained vaginal bleeding. 

Inform all your healthcare providers of any current or recently started or stopped medications, including prescription/nonprescription drugs, vitamins, and herbal supplements, to reduce the risk of drug interaction with Seasonale. 

Some of the products that may interact with Seasonale include: 

• Aromatase inhibitors (e.g., anastrozole, exemestane) 
• Fezolinetant 
• Ospemifene 
• Tamoxifen 
• Tizanidine 
• Tranexamic acid 
• Certain combination products for chronic hepatitis C treatment: 
  • Mbitasvir/paritaprevir/ritonavir (with or without dasabuvir) 

The efficacy of Seasonale can be compromised by certain drugs that diminish its concentration in the body. This may result in an increased risk of pregnancy. Examples of such drugs include: 

• Griseofulvin 
• Modafinil 
• Rifamycins (e.g., rifampin, rifabutin) 
• Ritonavir 
• St. John’s wort 
• Antiseizure medications (e.g., barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate) 
• HIV drugs (e.g., nelfinavir, nevirapine) 

Inform your doctor about any new spotting or breakthrough bleeding, as these could indicate potential issues with the effectiveness of your birth control. 

Vomiting or diarrhea may reduce the effectiveness of Seasonale. If you experience these symptoms, consider using a backup birth control method (e.g., condoms, spermicide). 

Seasonale usage may impact specific lab tests (e.g., blood clotting factors, thyroid), leading to potentially inaccurate results. Inform lab personnel and all healthcare providers about your use of oral contraceptives. 

Seasonale may induce spotty darkening of the skin, primarily on the face. If you have encountered skin color changes during pregnancy or previous use of oral contraceptives, avoid exposure to natural or artificial sunlight while taking this medication. Ensure you wear protective clothing, sunglasses, and sunscreen when outside. 

The risk of blood clots, stroke, or heart attack is significantly amplified by smoking. Individuals over the age of 35 who smoke should refrain from taking Seasonale. 

Notify your physician regarding any recent surgical procedures, future operations, and prolonged immobility (e.g., lengthy flights). These conditions elevate the risk of developing blood clots, especially while utilizing hormonal contraception. Temporary discontinuation of Seasonale or implementation of specific measures may be required. 

Inform your doctor and pharmacist about your contact lens usage. If you experience any alterations in vision or encounter difficulties wearing your lenses while taking Seasonale, seek assistance from an eye specialist. 

Seasonale should not be used during pregnancy. Discontinue this medication and promptly inform your doctor if you become pregnant or miss two consecutive menstrual periods. If you have recently given birth, wait at least four weeks before starting birth control pills. 

Seasonale may reduce breast milk production, and a small amount can pass into breast milk, potentially affecting the nursing infant negatively. Prior to breastfeeding, consult with your doctor.