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Generess Fe Side Effects

Generic name: ethinyl estradiol / norethindrone

Medically reviewed by Drugs.com. Last updated on Jan 31, 2024.

Note: This document contains side effect information about ethinyl estradiol / norethindrone. Some dosage forms listed on this page may not apply to the brand name Generess Fe.

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

Warning

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 Generess Fe

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

Other side effects of Generess Fe

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

For Healthcare Professionals

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

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

Common (1% to 10%): Vaginal candidiasis, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal/irregular bleeding, metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage, breast pain, dysmenorrhea, vaginal hemorrhage, dysfunctional uterine bleeding

Frequency not reported: Ovarian vein thrombosis, vaginitis, amenorrhea, breakthrough bleeding, breast enlargement, breast secretion, cervical erosion changed, cervical secretion, menstrual flow changed, diminution in lactation, spotting, temporary infertility after discontinuation of treatment, premenstrual syndrome, uterine fibroid disease exacerbated

Postmarketing reports: Vaginal infection, pollakiuria, dysuria, ovarian cyst, pelvic pain, ovarian cyst rupture, pelvic fluid collection, nipple pain, nipple discharge, galactorrhea, fibrocystic breast change, breast disorder, breast mass, uterine leiomyomata size increased, cervical ectropion changed, endometrial hyperplasia, ovarian cyst, uterine enlargement[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Blood pressure increased

Frequency not reported: Deep vein thrombosis, myocardial infarction, hypertension, arterial thromboembolism, thrombophlebitis

Postmarketing reports: Coronary artery thrombosis, palpitation, tachycardia, angina pectoris, hot flush, heart rate irregular[Ref]

Gastrointestinal

Common (1% to 10%): Nausea/vomiting, abdominal pain

Frequency not reported: Abdominal cramps, bloating, colitis, dyspepsia, inflammatory bowel disease, Crohn's disease, ulcerative colitis, mesenteric thrombosis

Postmarketing reports: Constipation, pancreatitis[Ref]

Nervous system

Common (1% to 10%): Headache

Frequency not reported: Migraine, dizziness, cerebral hemorrhage, cerebral thrombosis

Postmarketing reports: Loss of consciousness, hyperesthesia, paresthesia, hypoesthesia, somnolence, sensory disturbance, transient ischemic attack, ischemic stroke, chorea, epilepsy exacerbated, dementia, hemiparesis[Ref]

Oncologic

Frequency not reported: Hepatic adenoma, hepatic carcinoma, benign liver tumor

Postmarketing reports: Hemangioma of liver, breast cancer, ovarian cancer, endometrial cancer, uterine cancer[Ref]

Endocrine

Postmarketing reports: Hypothyroidism, hyperthyroidism[Ref]

Psychiatric

Common (1% to 10%): Mood swing, depression, mood changed, anxiety

Frequency not reported: Nervousness

Postmarketing reports: Insomnia, suicidal ideation, panic attack, libido changed, homicidal ideation, dissociation, bipolar disorder, mood disturbed, irritability[Ref]

Dermatologic

Common (1% to 10%): Acne

Frequency not reported: Hirsutism, loss of scalp hair, melasma, chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, photosensitivity, pruritus

Postmarketing reports: Alopecia, generalized rash, allergic rash, skin discoloration, urticaria, angioedema, night sweats, angioedema, hirsutism, skin burning sensation, generalized erythema[Ref]

Hepatic

Frequency not reported: Liver disease, gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome

Postmarketing reports: Cholelithiasis, cholecystitis[Ref]

Hematologic

Frequency not reported: Hemolytic uremic syndrome

Postmarketing reports: Anemia[Ref]

Immunologic

Postmarketing reports: Hypersensitivity reaction, anaphylactic/anaphylactoid reaction[Ref]

Ocular

Frequency not reported: Corneal curvature change/steepening, contact lens intolerance, cataracts, retinal thrombosis

Postmarketing reports: Vision blurred, vision impaired, corneal thinning, fungal infection, transient blindness[Ref]

Respiratory

Frequency not reported: Pulmonary embolism

Postmarketing reports: Asthma exacerbated, dyspnea[Ref]

Musculoskeletal

Frequency not reported: Leg cramp, backache

Postmarketing reports: Myalgia, arthralgia, back pain[Ref]

Metabolic

Common (1% to 10%): Weight fluctuation

Frequency not reported: Tolerance to carbohydrates reduced

Postmarketing reports: Appetite increased, appetite decreased, diabetes mellitus, hypoglycemia, hypocalcemia, triglycerides increased, blood glucose abnormal[Ref]

Other

Common (1% to 10%): Cervical smear abnormal, weight gain, edema

Frequency not reported: Fatigue, porphyria, Vitamin B6 deficient

Postmarketing reports: Weight decreased, peripheral edema, malaise, chest pain[Ref]

Renal

Frequency not reported: Renal function impaired

Postmarketing reports: Cystitis-like syndrome[Ref]

References

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

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

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

4. Cerner Multum, Inc. Australian Product Information.

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

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

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

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

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

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.