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Orsythia

Last reviewed on RxList: 3/4/2020
Orsythia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Medical Editor: John P. Cunha, DO, FACOEP

What Is Orsythia?

Orsythia (levonorgestrel and ethinyl estradiol kit) is a combination of female hormones used to prevent pregnancy in women who elect to use oral contraceptives as a method of contraception.

What Are Side Effects of Orsythia?

Side effects of Orsythia include:

  • acne,
  • missed menstrual periods,
  • anaphylactic reactions (including hives, swelling, and severe reactions with respiratory and circulatory symptoms),
  • breast tenderness/pain/enlargement,
  • nipple discharge,
  • changes in vaginal discharge,
  • problems with contact lenses,
  • dizziness,
  • fluid retention (edema),
  • gastrointestinal symptoms (abdominal pain, cramps, and bloating),
  • excess unwanted hair growth,
  • temporary infertility after discontinuation of treatment,
  • diminution in lactation when given immediately postpartum,
  • changes in sex drive,
  • dark or tan skin discoloration,
  • changes in menstrual periods,
  • mood changes (including depression),
  • nausea,
  • nervousness,
  • pancreatitis,
  • rash (allergic),
  • hair loss,
  • spotting,
  • vaginitis, vaginal yeast infection,
  • vomiting, and
  • changes in weight or appetite

Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use. Women who use oral contraceptives are strongly advised not to smoke.

Dosage for Orsythia

The dosage of Orsythia is one pink tablet daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Orsythia be taken at the same time each day.

Orsythia In Children

Safety and efficacy of Orsythia have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of Orsythia before menarche is not indicated.

What Drugs, Substances, or Supplements Interact with Orsythia?

Orsythia may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Orsythia During Pregnancy and Breastfeeding

Orsythia is not recommended for use during pregnancy. Small amounts of oral-contraceptive steroids and/or metabolites pass into breast milk, and adverse effects on the child may include jaundice and breast enlargement. Combination oral contraceptives such as Orsythia given in the postpartum period may decrease the quantity and quality of breast milk. Nursing mothers are advised not to use combination oral contraceptives and to use other forms of contraception while breastfeeding.

Additional Information

Our Orsythia (levonorgestrel and ethinyl estradiol kit) 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.

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.

QUESTION

Which of the following are methods for contraception? See Answer
Orsythia Professional Information

SIDE EFFECTS

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

Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

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

Acne
Amenorrhea
Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
Breast changes: tenderness, pain, enlargement, secretion
Budd-Chiari syndrome
Cervical erosion and secretion, change in
Cholestatic jaundice
Chorea, exacerbation of
Colitis
Contact lenses, intolerance to
Corneal curvature (steepening), change in
Dizziness
Edema/fluid retention
Erythema multiforme
Erythema nodosum
Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)
Hirsutism
Infertility after discontinuation of treatment, temporary
Lactation, diminution in, when given immediately postpartum
Libido, change in
Melasma/chloasma which may persist
Menstrual flow, change in
Mood changes, including depression
Nausea
Nervousness
Pancreatitis
Porphyria, exacerbation of
Rash (allergic)
Scalp hair, loss of
Serum folate levels, decrease in
Spotting
Systemic lupus erythematosus, exacerbation of
Unscheduled bleeding
Vaginitis, including candidiasis
Varicose veins, aggravation of
Vomiting
Weight or appetite (increase or decrease), change in

The following adverse reactions have been reported in users of oral contraceptives:

Cataracts
Cystitis-like syndrome
Dysmenorrhea
Hemolytic uremic syndrome
Hemorrhagic eruption
Optic neuritis, which may lead to partial or complete loss of vision
Premenstrual syndrome
Renal function, impaired

Read the entire FDA prescribing information for Orsythia (Levonorgestrel and Ethinyl Estradiol Tablets)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Related Resources for Orsythia

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

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