Gianvi Side Effects

Generic name: drospirenone / ethinyl estradiol

Medically reviewed by Drugs.com. Last updated on Nov 5, 2024.

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

Applies to drospirenone / ethinyl estradiol: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure 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 have had a baby 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 miss 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, talk to your doctor. You might need a pregnancy test.

If you suspect that you may be pregnant, and check with your doctor immediately.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using birth control pills containing drospirenone, 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, especially in the first 6 months of use. This risk may be higher if you are using a birth control pill containing drospirenone and ethinyl estradiol. 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 trouble breathing, a sudden loss of coordination, or vision changes while using this medicine.

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 to check your eyes.

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

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.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

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 Gianvi

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

Other side effects of Gianvi

Some side effects of drospirenone / ethinyl estradiol 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 drospirenone / ethinyl estradiol: oral tablet.

General adverse events

The most common adverse events were irregular uterine bleeding, nausea, breast tenderness, and headache.^[Ref]

Genitourinary

• Very common (10% or more): Breast pain or discomfort (17.9%), menstrual disorders (17%), female genital tract bleeding (14%), premenstrual syndrome (13.2%)
• Common (1% to 10%): Vaginal candidiasis, leukorrhea, intermenstrual bleeding, cystitis, unscheduled uterine bleeding/genital tract bleeding NOS, metrorrhagia, amenorrhea, breast tenderness, vaginal discharge, cervical polyp
• Uncommon (0.1% to 1%): Vaginitis, pelvic pain, breast enlargement, fibrocystic breast, genital discharge, dysmenorrhea, hypomenorrhea, menorrhagia, vaginal dryness, Pap smear suspicious, breast hypertrophy
• Rare (less than 0.1%): Dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast cyst, breast hyperplasia, endometrial atrophy, ovarian cyst, uterine enlargement, breast discharge
• Frequency not reported: Cervical dysplasia^[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, which occurs in approximately 10% of treated women and may be more frequent during the first cycles of therapy. Some early reports suggested an association between oral contraceptive use and gallbladder disease. Abdominal pain and gastroenteritis have been reported in postmarketing experience.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Hypertension, hypotension, varicose vein
• Rare (less than 0.1%): Venous and arterial thromboembolic events, tachycardia, vascular disorder, phlebitis^[Ref]

Venous and arterial thromboembolic events includes peripheral deep vein occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism, infarction, intracardiac thrombosis, retinal vein occlusion, myocardial infarction, cerebral infarction, and stroke.^[Ref]

Nervous system

• Very common (10% or more): Headache (20%)
• Common (1% to 10%): Dizziness, migraine
• Uncommon (0.1% to 1%): Somnolence, dizziness, paresthesia, asthenia
• Rare (less than 0.1%): Vertigo, tremor, syncope^[Ref]

Psychiatric

• Common (1% to 10%): Depression/depressive mood, nervousness, emotional lability, decrease and loss of libido, libido increased, affect lability
• Rare (less than 0.1%): Anorgasmia, insomnia^[Ref]

Other

• Common (1% to 10%): Fatigue
• Uncommon (0.1% to 1%): Weight gain, weight loss, hot flushes, edema (generalized)
• Rare (less than 0.1%): Candidiasis, malaise, hypoacusis^[Ref]

Dermatologic

• Common (1% to 10%): Acne
• Uncommon (0.1% to 1%): Pruritus, rash, increased sweating, eczema, alopecia
• Rare (less than 0.1%): Chloasma, dermatitis acneiform, dry skin, erythema nodosum, erythema multiforme, hypertrichosis, skin disorder, skin striae, contact dermatitis, photosensitive dermatitis, skin nodule
• Postmarketing reports: Angioedema^[Ref]

Respiratory

• Common (1% to 10%): Pharyngitis, sinusitis
• Rare (less than 0.1%): Epistaxis, asthma^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Hypersensitivity, allergic reaction^[Ref]

Oncologic

• Rare (less than 0.1%): Breast neoplasm, breast cancer, focal nodular hyperplasia
• Frequency not reported: Uterine leiomyoma
• Postmarketing reports: Liver tumors^[Ref]

Hepatic

• Rare (less than 0.1%): Biliary pain, cholecystitis acute
• Postmarketing reports: Gallbladder disease, liver function disturbances^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Fluid retention
• Rare (less than 0.1%): Increased appetite, anorexia, hyperkalemia, hyponatremia^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Back pain, pain in extremity, muscle cramps
• Postmarketing reports: Systemic lupus erythematosus^[Ref]

Ocular

• Rare (less than 0.1%): Conjunctivitis, dry eye, eye disorder, contact lens intolerance^[Ref]

Hematologic

• Rare (less than 0.1%): Anemia, thrombocythemia^[Ref]

Endocrine

• Rare (less than 0.1%): Endocrine disorder^[Ref]

See also:

Further information

Gianvi 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