Seasonale (Levonorgestrel / Ethinyl Estradiol) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

• Thrombophlebitis
• Arterial thromboembolism
• Pulmonary embolism
• Myocardial infarction
• Cerebral hemorrhage
• Cerebral thrombosis
• Hypertension
• Gallbladder disease
• Hepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives:

• Mesenteric thrombosis
• Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related:

• Nausea
• Vomiting
• Gastrointestinal symptoms (such as abdominal cramps and bloating)
• Breakthrough bleeding
• Spotting
• Change in menstrual flow
• Amenorrhea
• Temporary infertility after discontinuation of treatment
• Edema/fluid retention
• Melasma/chloasma which may persist
• Breast changes: tenderness, enlargement, and secretion
• Change in weight or appetite (increase or decrease)
• Change in cervical ectropion and secretion
• Possible diminution in lactation when given immediately postpartum
• Cholestatic jaundice
• Migraine headache
• Rash (allergic)
• Mood changes, including depression
• Vaginitis, including candidiasis
• Change in corneal curvature (steepening)
• Intolerance to contact lenses
• Decrease in serum folate levels
• Exacerbation of systemic lupus erythematosus
• Exacerbation of porphyria
• Exacerbation of chorea
• Aggravation of varicose veins
• Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:

• Premenstrual syndrome
• Cataracts
• Optic neuritis which may lead to partial or complete loss of vision
• Cystitis-like syndrome
• Headache
• Nervousness
• Dizziness
• Hirsutism
• Loss of scalp hair
• Erythema multiforme
• Erythema nodosum
• Hemorrhagic eruption
• Impaired renal function
• Hemolytic uremic syndrome
• Budd-Chiari syndrome
• Acne
• Changes in libido
• Colitis
• Pancreatitis
• Dysmenorrhea

SIDE EFFECTS OF ORAL CONTRACEPTIVES

In addition to the risks and more serious side effects discussed above (see RISKS OF TAKING ORAL CONTRACEPTIVES, ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY and WARNING SIGNALS sections), the following may also occur:

1. Irregular vaginal bleeding
   Irregular vaginal bleeding or spotting (bleeding or spotting between your expected period) is likely to occur while you are taking Seasonale®. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few 91-day cycles of Seasonale® use, tends to decrease during later cycles, but may also occur after you have been taking Seasonale® for some time. Such bleeding usually does not indicate any serious problems. It is important to continue taking your pills on schedule even if you are having irregular bleeding. If the bleeding lasts for more than 7 consecutive days, talk to your healthcare provider.
   When you take Seasonale®, you need to consider the convenience of fewer expected menstrual periods (4 per year instead of 13) and the inconvenience of more irregular vaginal bleeding or spotting. In a clinical trial comparing Seasonale® (91-day cycles) to a conventional equivalent dosage 28-day cycle oral contraceptive, more women using Seasonale® discontinued treatment because of bleeding problems (7.7% of the Seasonale® users compared to 1.8% of the 28-day cycle users).
   The following Table shows the percentages of women with 7 or more and 20 or more days of intermenstrual bleeding and/or spotting in the Seasonale® and the 28-day cycle treatment groups.
   

   Percentages (%) of Women with Intermenstrual Bleeding and/or Spotting Number of days of intermenstrual bleeding and/or spotting Percentage of subjects with intermenstrual bleeding or spotting * Seasonale ® Cycle 1 Cycle 4 7 or more days 65% 42% 20 or more days 35% 15% 28-day cycle pill Cycles 1-4 Cycles 10-13 7 or more 38% 39% 20 or more days 6% 4% * Based on spotting and/or bleeding on days 1-84 of a 91 day cycle in the Seasonale® subjects and days 1-21 of a 28 day cycle over 4 cycles in the 28-day dosing regimen.

   
   Total days of bleeding and/or spotting (withdrawal plus intermenstrual) were similar over one year of treatment for Seasonale® subjects and subjects on the 28-day cycle regimen.
2. Contact lenses
   If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your healthcare provider.
3. Fluid retention
   Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your healthcare provider.
4. Melasma
   A spotty darkening of the skin is possible, particularly of the face.
5. Other side effects
   Other side effects may include nausea and vomiting, change in appetite, breast tenderness, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, and allergic reactions.
   If any of these side effects bother you, call your healthcare provider.