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Ortho Cyclen Side Effects

Generic Name: ethinyl estradiol / norgestimate

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

For the Consumer

Applies to ethinyl estradiol / norgestimate: oral tablet

Along with its needed effects, ethinyl estradiol / norgestimate 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 / norgestimate:

Incidence not known
  • Abdominal or stomach pain
  • absent, missed, or irregular menstrual periods
  • anxiety
  • change in vision
  • changes in skin color
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark urine
  • diarrhea
  • dizziness or lightheadedness
  • fainting
  • fever
  • headache
  • hives or welts
  • itching skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
  • nausea and vomiting
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pains in the chest, groin, or legs, especially in the calves of the legs
  • pounding in the ears
  • rash
  • redness of the skin
  • severe headaches of sudden onset
  • slow or fast heartbeat
  • sudden loss of coordination or slurred speech
  • sudden onset of shortness of breath for no apparent reason
  • sudden shortness of breath or troubled breathing
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood

Some side effects of ethinyl estradiol / norgestimate 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
  • Abdominal or stomach cramps
  • bloating
  • blotchy spots on the exposed skin
  • breast enlargement or tenderness
  • discouragement
  • feeling sad or empty
  • irritability
  • itching of the vagina or outside the genitals
  • loss of interest or pleasure
  • pain during sexual intercourse
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • trouble wearing contact lenses

For Healthcare Professionals

Applies to ethinyl estradiol / norgestimate: oral tablet

General

The most frequently reported side effects were headache/migraine, nausea/vomiting, gastrointestinal disorder, diarrhea, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), dysmenorrhea, metrorrhagia, abnormal withdrawal bleeding, mood disorders (including depression and mood altered), flatulence, nervousness, rash, and changes in weight (including weight increased or decreased).[Ref]

Genitourinary

Very common (10% or more): Breast issues (10.3%), dysmenorrhea, metrorrhagia, abnormal withdrawal bleeding
Common (1% to 10%): Vaginal infection, genital discharge, breast tenderness, breast pain, breast enlargement, breast swelling, breast discharge, breast discomfort, nipple pain, menstrual discomfort, menstrual disorder, vulvovaginal infection, urinary tract infection, amenorrhea, premenstrual syndrome
Uncommon (0.1% to 1%): Ovarian cyst, vulvovaginal dryness
Rare (less than 0.1%): Vaginal discharge
Frequency not reported: Suppressed lactation[Ref]

Some women experience oligomenorrhea and amenorrhea following termination or oral contraceptive use.[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (16.3%), gastrointestinal disorder, diarrhea
Common (1% to 10%): Abdominal/gastrointestinal pain, flatulence, abdominal distention, constipation
Rare (less than 0.1%): Pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache/migraine (up to 33.6%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Syncope, paresthesia
Frequency not reported: Convulsion, cerebrovascular accident[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitation, thrombosis, hypertension, hot flush
Rare (less than 0.1%): Tachycardia, arterial thromboembolism
Frequency not reported: Myocardial infarction, venous thromboembolic event, deep vein thrombosis[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea
Frequency not reported: Pulmonary embolism[Ref]

Dermatologic

Common (1% to 10%): Rash, acne
Uncommon (0.1% to 1%): Alopecia, hirsutism, urticaria, pruritus, erythema, skin discoloration
Rare (less than 0.1%): Hyperhidrosis, photosensitivity reaction
Frequency not reported: Angioedema, erythema nodosum, night sweats[Ref]

Metabolic

Common (1% to 10%): Weight fluctuation, fluid retention
Rare (less than 0.1%): Appetite disorder
Frequency not reported: Dyslipidemia[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms, pain in extremity, back pain
Uncommon (0.1% to 1%): Myalgia[Ref]

Oncologic

Uncommon (0.1% to 1%): Cervical dysplasia
Rare (less than 0.1%): Breast cyst
Frequency not reported: Breast cancer, carcinoma of the cervix in situ, hepatic adenoma, breast cancer, benign breast neoplasm, focal nodular hyperplasia, fibroadenoma of breast[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis[Ref]

Psychiatric

Common (1% to 10%): Depression, mood altered, mood disorder, nervousness, insomnia
Uncommon (0.1% to 1%): Anxiety, libido disorder
Frequency not reported: Irritability, mood swing[Ref]

Immunologic

Common (1% to 10%): Hypersensitivity[Ref]

Other

Common (1% to 10%): Weight increased, weight decreased, fatigue, chest pain, asthenic conditions, edema[Ref]

Ocular

Uncommon (0.1% to 1%): Vision impaired, dry eye
Frequency not reported: Contact lens intolerance, retinal vascular thrombosis[Ref]

References

1. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho Pharmaceutical Corporation, Raritan, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Ortho Tri-Cyclen Lo (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical, Raritan, NJ.

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

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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