Finzala Side Effects

Generic name: ethinyl estradiol / norethindrone

Medically reviewed by Drugs.com. Last updated on Dec 3, 2024.

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

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

Other dosage forms:

• oral tablet, oral tablet chewable

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you missed a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using norethindrone and ethinyl estradiol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Finzala

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:

Other side effects of Finzala

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:

For healthcare professionals

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

General adverse events

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]

See also:

Further information

Finzala 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer