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Ethinyl estradiol / norgestrel Side Effects

In Summary

Commonly reported side effects of ethinyl estradiol/norgestrel include: vulvovaginal candidiasis, breakthrough bleeding, decreased glucose tolerance, headache, increased blood pressure, migraine, spotty menstruation, vaginitis, and dizziness. Other side effects include: abdominal cramps, abdominal distention, acne vulgaris, breast changes, nausea, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ethinyl estradiol / norgestrel: oral tablet

Along with its needed effects, ethinyl estradiol / norgestrel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / norgestrel:

Incidence not known

  • Absent, missed, or irregular menstrual periods
  • backache
  • belching
  • bleeding between periods
  • blurred vision
  • breast tenderness, pain, enlargement, or secretion
  • change in the amount of bleeding during periods
  • change in the pattern of monthly periods
  • changes in skin color, pain, tenderness, swelling of the foot or leg
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • clear or bloody discharge from the nipple
  • cough
  • dark urine
  • diarrhea
  • difficulty swallowing
  • dimpling of the breast skin
  • dizziness
  • dull ache or feeling of pressure or heaviness in the legs
  • fast heartbeat
  • fever
  • full or bloated feeling or pressure in the stomach
  • headache
  • headache, severe and throbbing
  • heartburn
  • hives
  • inability to speak
  • indigestion
  • inverted nipple
  • itching of the vagina or genital area
  • itching skin near damaged veins
  • light vaginal bleeding between periods and after intercourse
  • loss of appetite
  • lump in the breast or under the arm
  • nausea and vomiting
  • nervousness
  • pain during sexual intercourse
  • pain or discomfort in the arms, jaw, back or neck
  • persistent crusting or scaling of the nipple
  • pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness or swelling of the breast
  • seizures
  • severe or sudden headache
  • slow or fast heartbeat
  • slurred speech
  • sore on the skin of the breast that does not heal
  • stomach discomfort, upset, or pain
  • stopping of menstrual bleeding
  • sweating
  • swelling, pain, or tenderness in the upper abdominal area
  • swollen feet and ankles
  • temporary blindness
  • thick, white vaginal discharge with no odor or with a mild odor
  • tightness in the chest
  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
  • unpleasant breath odor
  • unusual stopping of menstrual bleeding
  • unusual tiredness or weakness
  • vomiting of blood
  • weakness in the arm or leg on one side of the body, sudden and severe
  • yellow eyes or skin

Some side effects of ethinyl estradiol / norgestrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • Acne
  • changes in weight or appetite
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • increased hair growth, especially on the face
  • intolerance to contact lenses
  • loss in sexual ability, desire, drive, or performance
  • loss of hair on the scalp

For Healthcare Professionals

Applies to ethinyl estradiol / norgestrel: oral tablet

General

The frequency of the reported side effects is unknown, however, an increased risk of the following side effects has been associated with the use of oral contraceptives: thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis, hypertension, gallbladder disease, hepatic adenomas, carcinomas, or benign liver tumors.[Ref]

Genitourinary

Frequency not reported: Breakthrough bleeding, spotting, menstrual flow changed, amenorrhea, cervical erosion change, cervical secretion change, decreased lactation, vaginal candidiasis, premenstrual syndrome, cystitis-like syndrome, vaginitis, dysmenorrhea[Ref]

Gastrointestinal

Frequency not reported: Mesenteric thrombosis, nausea, vomiting, gastrointestinal symptoms, abdominal cramps, bloating, colitis, pancreatitis[Ref]

Oncologic

Frequency not reported: Hepatic adenoma, hepatic carcinoma, benign liver tumor, breast carcinoma, carcinoma of reproductive organs[Ref]

Cardiovascular

Frequency not reported: Thrombophlebitis, arterial thromboembolism, myocardial infarction, hypertension, cerebral-vascular disease with mitral valve prolapse, venous thrombosis, varicose veins aggravated[Ref]

Hematologic

Frequency not reported: Hemolytic uremic syndrome, sickle-cell disease, hemolytic uremic syndrome[Ref]

Endocrine

Frequency not reported: Temporary infertility following discontinuation, breast tenderness, breast enlargement, breast secretion[Ref]

Hepatic

Frequency not reported: Gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome[Ref]

Psychiatric

Frequency not reported: Depression, nervousness, libido changed, mood changed[Ref]

Immunologic

Frequency not reported: Anaphylactic/anaphylactoid reactions[Ref]

Other

Frequency not reported: Edema/fluid retention, weight increased, weight decreased, reduced tolerance to carbohydrates, corneal curvature steepening, contact lens intolerance, congenital anomaly, porphyria, serum folate decreased[Ref]

Nervous system

Frequency not reported: Cerebral hemorrhage, cerebral thrombosis, migraine, headache, dizziness, exacerbation of chorea[Ref]

Ocular

Frequency not reported: Retinal thrombosis, cataracts, optic neuritis[Ref]

Musculoskeletal

Frequency not reported: Lupus-like syndrome[Ref]

Metabolic

Frequency not reported: Appetite changed, glucose tolerance decreased, serum folate depressed[Ref]

Respiratory

Frequency not reported: Pulmonary embolism[Ref]

Renal

Frequency not reported: Renal function impaired[Ref]

Dermatologic

Frequency not reported: Melasma, allergic rash, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, acne, urticaria, angioedema[Ref]

References

1. "Product Information. Cryselle 28 (ethinyl estradiol-norgestrel)." Barr Pharmaceuticals Inc, Pomona, NY.

2. "Product Information. Elinest (ethinyl estradiol-norgestrel)." Northstar Rx LLC, Memphis, TN.

3. "Product Information. Ogestrel-28 (ethinyl estradiol-norgestrel)." Watson Pharmaceuticals, Parsippany, NJ.

4. "Product Information. Low-Ogestrel (ethinyl estradiol-norgestrel)." Mayne Pharma Inc, Paramus, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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