Drospirenone / Ethinyl Estradiol / Levomefolate Calcium Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 14, 2025.

Applies to drospirenone / ethinyl estradiol / levomefolate calcium: 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 your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

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 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 pink 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. You should continue to take folate supplements.

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 have problems wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

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. You may need to stop using this medicine several days before having surgery or certain medical tests.

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

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

Other side effects

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

General adverse events

The more commonly reported adverse events include menstrual irregularities, nausea/vomiting, breast pain/tenderness, and headache/migraine.

Cardiovascular

• Postmarketing reports: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)^[Ref]

Genitourinary

Combination Oral Contraceptives:

• Very common (10% or more): Menstrual irregularities (up to 24.9%)
• Frequency not reported: Menstrual irregularities including vaginal hemorrhage (primarily spotting), metrorrhagia, menorrhagia, breast tenderness, decreased libido, unscheduled (breakthrough or intracyclic) bleeding

The average number of episodes of bleeding per 90 days was 3.2 in Cycles 4 to 6; the average number of bleeding and/or spotting days was 15.1 days. The intensity of bleeding based on the ratio of spotting-only days versus total bleeding and/or spotting days was 5.2/15.1 day.

Gastrointestinal

• Common (1% to 10%): Nausea, vomiting,
• Postmarketing reports: Gallbladder disease, inflammatory bowel disease^[Ref]

Hypersensitivity

• Postmarketing reports: Hypersensitivity including anaphylactic reaction^[Ref]

Hepatic

• Postmarketing reports: Liver function disturbances, liver tumors^[Ref]

Metabolic

• Postmarketing reports: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)^[Ref]

Nervous system

• Common (1% to 10%): Migraine, headaches^[Ref]

Ocular

• Postmarketing reports: Retinal thrombosis^[Ref]

Psychiatric

• Frequency not reported: Irritability, depression, affect lability^[Ref]

Oncologic

• Frequency not reported: Cervix carcinoma stage 0
• Postmarketing reports: Cervical dysplasia^[Ref]

Musculoskeletal

• Postmarketing reports: Systemic lupus erythematosus^[Ref]

Dermatologic

• Postmarketing reports: Chloasma, angioedema, erythema nodosum, erythema multiforme^[Ref]

Other

• Common (1% to 10%): Fatigue

See also:

Further information

Drospirenone/ethinyl estradiol/levomefolate calcium 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