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Ovral-21 Side Effects

Generic Name: ethinyl estradiol / norgestrel

Note: This document contains side effect information about ethinyl estradiol / norgestrel. Some of the dosage forms listed on this page may not apply to the brand name Ovral-21.

For the Consumer

Applies to ethinyl estradiol / norgestrel: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Coughing up blood.
  • Shortness of breath.
  • Chest pain or pressure.
  • Very bad dizziness or passing out.
  • Very upset stomach or throwing up.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Very bad headache.
  • Low mood (depression).
  • Feeling very tired or weak.
  • Very bad belly pain.
  • Swelling.
  • Not able to pass urine or change in how much urine is passed.
  • A lump in the breast, breast soreness, or nipple discharge.
  • Vaginal itching or discharge.
  • Spotting or vaginal bleeding that is very bad or does not go away.
  • Bulging eyes.
  • Change in eyesight.
  • Change in how contact lenses feel in the eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling more or less hungry.
  • Dizziness.
  • Weight gain.
  • Headache.
  • Upset stomach or throwing up.
  • Cramps.
  • Bloating.
  • Enlarged breasts.
  • Breast soreness.
  • Hair loss.
  • Pimples (acne).
  • Period (menstrual) changes. These include spotting or bleeding between cycles.
  • Lowered interest in sex.
  • This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

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

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

Some side effects of Ovral-21 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

More about Ovral-21 (ethinyl estradiol / norgestrel)

Consumer resources

Other brands: Cryselle, Lo/Ovral, Elinest, Low-Ogestrel-21, ... +2 more

Professional resources

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Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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