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Cyclafem 0.5/35 Side Effects

Generic name: ethinyl estradiol / norethindrone

Medically reviewed by Drugs.com. Last updated on Feb 7, 2024.

Note: This document provides detailed information about Cyclafem 0.5/35 Side Effects associated with ethinyl estradiol / norethindrone. Some dosage forms listed on this page may not apply specifically to the brand name Cyclafem 0.5/35.

Applies to ethinyl estradiol / norethindrone: oral capsule liquid filled, oral tablet, oral tablet chewable.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Junel®: Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

For this reason, COCs, including Junel, are contraindicated in women who are over 35 years of age and smoke.Microgestin®: Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use.

This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age.

Women who use oral contraceptives should be strongly advised not to smoke.

Serious side effects of Cyclafem 0.5/35

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

Incidence not known

  • 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
  • fast heartbeat
  • 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
  • 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
  • stomach pain
  • sudden loss of coordination or slurred speech
  • sweating
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood

Other side effects of Cyclafem 0.5/35

Some side effects of ethinyl estradiol / norethindrone 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

  • bloating
  • blotchy spots on the exposed skin
  • breast enlargement or tenderness
  • discouragement
  • feeling sad or empty
  • irritability
  • itching of the vagina or outside genitals
  • loss of interest or pleasure
  • pain during sexual intercourse
  • stomach cramps
  • 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 / norethindrone: oral capsule, oral tablet, oral tablet chewable, oral tablet disintegrating.

General

The most frequently reported side effects were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, abdominal pain, mood changes, bacterial vaginitis, acne, irregular uterine bleeding, and weight gain.[Ref]

Genitourinary

Cardiovascular

Gastrointestinal

Nervous system

Oncologic

Endocrine

Psychiatric

Dermatologic

Hepatic

Hematologic

Immunologic

Ocular

Respiratory

Musculoskeletal

Metabolic

Other

Renal

References

1. "Product Information. femhrt (ethinyl estradiol-norethindrone)." Parke-Davis

2. (2002) "Product Information. Estrostep Fe (ethinyl estradiol-norethindrone)." Parke-Davis

3. Cerner Multum, Inc. "UK Summary of Product Characteristics."

4. Cerner Multum, Inc. "Australian Product Information."

5. (2017) "Product Information. Loestrin 24 Fe (ethinyl estradiol-norethindrone)." Warner Chilcott Laboratories

6. (2017) "Product Information. Briellyn (ethinyl estradiol-norethindrone)." Glenmark Pharmaceuticals Inc

7. (2017) "Product Information. Femcon FE (ethinyl estradiol-norethindrone)." Actavis (formerly Abrika Pharmaceuticals LLP)

8. (2017) "Product Information. Lo Loestrin Fe (ethinyl estradiol-norethindrone)." Warner Chilcott Laboratories

9. (2017) "Product Information. Lo Minastrin Fe (ethinyl estradiol-norethindrone)." Warner Chilcott Laboratories

Further information

Cyclafem 0.5/35 side effects can vary depending on the individual. 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.