Warnings

drospirenone-ethinyl estradiol

Medically Reviewed by Dr. Harshi Dhingra, M.D.

Last Reviewed: Mar 16, 2023

Warnings

Drospirenone and Ethinyl Estradiol (YASMIN) Risks, Warnings, and Complications

Drospirenone and ethinyl estradiol can cause serious adverse effects in some people. Talk to your doctor about other birth control pills if you are at a high risk of complications from drospirenone and ethinyl estradiol. Some of the potential risks of taking drospirenone and ethinyl estradiol include:

INCREASED RISK OF SERIOUS CARDIOVASCULAR EVENTS: An oral contraceptive regimen of combined estrogen and progestin (drospirenone ethinyl estradiol) can increase your risk of serious cardiovascular events such as blood clots, heart attacks, and strokes. This risk is especially high in women over the age of 35 years who are smokers. If you smoke, talk to your doctor about other safer alternatives for contraception.
INCREASED RISK OF BLOOD CLOTS: Studies show that taking oral contraceptives that contain drospirenone can raise venous thromboembolism risk (the risk of developing deep vein thrombosis (DVT) or blood clots in the leg veins). Combination oral contraceptives can also lead to blood in other parts of the body, such as the lungs (pulmonary embolism or PE), heart (heart attack), or brain (stroke). These are serious life-threatening conditions. Risk factors include smokers over the age of 35 years and non-smokers over the age of 40 years. Other risk factors include women with high blood pressure, obesity, and prediabetic and diabetic women. Underlying risk factors also include recent major surgery and bed rest, if a patient starts Yasmin postpartum less than a month after childbirth, and those taking a higher dose of estrogen. Seek emergency medical help if you develop signs and symptoms of a blood clot:
Brain: Weakness or numbness on one side of the body, trouble talking or walking, loss of balance, dizziness, blurred vision, confusion
Heart: Chest pain, sweating, nausea, dizziness
Lungs: Difficulty breathing, chest pain, cough
Eyes: Double vision, blurred vision, eye pain, bulging eyes
Legs: Cramps, pain, swelling, warmth, muscle tightness
INCREASED RISK OF BREAST CANCER AND CERVICAL CANCER: Although the results of studies are mixed, it is possible that ethinyl estradiol containing medications can increase the risk of breast cancer and cervical cancer. Your doctor may advise you to do monthly self-breast exams to aid early detection of breast cancer. Tell your healthcare provider without delay if you notice any abnormal lumps, pain, swelling, or other changes in your breasts while on drospirenone ethinyl estradiol.
Seek immediate medical help if you have abnormal withdrawal bleeding, abnormal vaginal discharge, or pain during sex.
INCREASE IN BLOOD PRESSURE: Taking combined oral contraceptives substances can lead to high blood pressure. Your healthcare provider may ask you to check your blood pressure regularly while on drospirenone ethinyl estradiol. Call your doctor if your blood pressure rises significantly while on this medicine. The risk is greater in older women and in those who take the pills for a long time.
HIGH CHOLESTEROL AND HIGH BLOOD SUGAR: Combined oral contraceptives can lead to impaired glucose tolerance and an increase in blood sugar levels. Additionally, birth control pills that contain progestins can lead to an increase in LDL (bad cholesterol) and triglyceride levels (a type of fat in the blood). This can increase your risk of coronary artery disease (heart disease). Your healthcare provider may recommend a different birth control pill if you have diabetes or high cholesterol. Keep all your healthcare appointments while you’re taking birth control pills so that your healthcare providers can monitor any clinically significant difference in your blood sugar and cholesterol levels.
LIVER DAMAGE AND LIVER TUMORS: Rarely, drospirenone ethinyl estradiol can cause liver damage and liver tumors. The risk is higher with higher doses of estrogen (more than 50 mcg). These high doses were typically present in earlier formulations of combined birth control pills. Newer low-dose COCs like Yasmin and Yaz contain less estrogen (30 mcg and 20 mcg, respectively). Tell your healthcare professional if you have liver problems before starting birth control pills. Call your doctor right away if you develop stomach pain, nausea, weakness, tiredness, light colored stools, dark urine, or yellowing of the eyes or skin while on birth control pills
HIGH POTASSIUM: Drospirenone can increase serum potassium concentration in some people. The risk is higher if you take the birth control pill with other medications that can increase potassium levels, such as ACE inhibitors, potassium sparing drugs, and potassium supplements. Make sure you follow your doctor’s instructions for monitoring serum potassium concentration when you first start taking the pill and periodically thereafter. Call your doctor right away if you develop signs of high potassium such as nausea, irregular heartbeat, or muscle weakness.

Precautions Before Starting Drospirenone and Ethinyl Estradiol

Tell your doctor if you have ever had an allergic reaction to drospirenone or ethinyl estradiol, other types of oral contraceptives, or any other medications. Your pharmacy can give you a list of active and inactive ingredients in drospirenone and ethinyl estradiol tablets.

Give your doctor a complete medical history. Drospirenone and ethinyl estradiol may not be right for people with certain health conditions, such as breast cancer, liver tumors, hepatic impairment (reduced liver function), liver disease, renal impairment (kidney disease), adrenal insufficiency, undiagnosed abnormal uterine bleeding, cigarette smoking, blood clots, thrombophilia, diabetes, high blood pressure, high cholesterol, coronary artery disease, heart attack, or migraine headaches. Also tell your doctor if you have had major surgery or are immobile for some other reason.

Give your doctor or pharmacist a complete list of your other medications, including prescription drugs, over-the-counter medicines, vitamins, supplements, and herbal products, especially St. John’s Wort. This will help avoid possible drug interactions between your birth control pills and your other medications.

Tell your doctor if you are pregnant, could be pregnant, are planning a pregnancy, or are nursing an infant with breast milk. Pregnant and breastfeeding women should talk to their healthcare provider about the risks versus benefits of taking birth control pills.

Precautions During Use of Drospirenone and Ethinyl Estradiol

Keep all your healthcare appointments. Take drospirenone and ethinyl estradiol on the first day of your menstrual period. This way you will be immediately protected against pregnancy. If you start the pill on any other day, use a backup method of contraception for at least 48 hours.

Call your doctor if you have a positive home pregnancy test or other signs and symptoms of pregnancy such as nausea and breast tenderness while on drospirenone and ethinyl estradiol.

If you miss a period while on the birth control pill, you could be pregnant. If you have taken all your doses as directed and you miss one period, continue taking the birth control pill. However, if you have not taken the pill as directed or if you miss two periods, call your doctor and use a backup method of birth control until you have a pregnancy test.

If you vomit or have diarrhea while on drospirenone and ethinyl estradiol, use a backup method of contraception for 48 hours. Talk to your doctor about an appropriate backup method before starting birth control pills.

Your doctor will tell you when to start taking the pill after childbirth, abortion, or miscarriage.

Tell all your healthcare providers that you are on drospirenone and ethinyl estradiol before any surgical treatment, including dental procedures.

Avoid smoking while taking drospirenone and ethinyl estradiol hormone therapy because it can increase your risk of blood clots, heart attacks, and strokes.

Drospirenone and Ethinyl Estradiol Drug Interactions

Certain medicines can affect how well drospirenone and ethinyl estradiol work. Taking drospirenone and ethinyl estradiol with other drugs can also increase the risk of severe adverse effects. Your doctor may change the doses of your medications or monitor you carefully for adverse effects if there are known interactions between drospirenone and ethinyl estradiol and your other medicines.

The following medications can have possible interactions with drospirenone and ethinyl estradiol:

Acetaminophen (APAP, Tylenol)
Antibiotics like erythromycin (E.E.S., E-Mycin, Erythrocin), clarithromycin (Biaxin), ampicillin (Principen), isoniazid (INH, Nydrazid), minocycline (Dynacin, Minocin), metronidazole (Flagyl), rifampin (Rifadin, Rimactane), rifabutin (Mycobutin), tetracycline (Sumycin)
Antiviral drugs like dasabuvir, ombitasvir, paritaprevir, ritonavir (Viekira Pak)
HIV medications like delavirdine (Rescriptor), indinavir (Crixivan), and ritonavir (Norvir)
Blood thinners (anticoagulants) like warfarin (Coumadin) and heparin
Antifungal drugs such as griseofulvin (Fulvicin, Grisactin, Grifulvin), ketoconazole (Nizoral), itraconazole (Sporanox), and fluconazole (Diflucan)
Cholesterol lowering medications like atorvastatin (Lipitor), cholestyramine (Questran, Locholest, Prevalite), and clofibrate (Atromid-S)
Immunosuppressants like cyclosporine (Neoral, Sandimmune)
Medications used to treat pulmonary hypertension such as bosentan (Tracleer)
H2 blockers like cimetidine (Tagamet)
Androgenic hormones like danazol (Danocrine)
Calcium channel blockers like diltiazem (Cardizem, Dilacor, Tiazac) and verapamil (Covera, Calan, Verelan, Isoptin)
Antidepressants like fluoxetine (Prozac, Sarafem, in Symbyax) and nefazodone
Anti-anxiety and insomnia medications like temazepam (Restoril)
Anti-seizure medications like carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), valproic acid (Depakene, Stavzor), lamotrigine (Lamictal), oxcarbazepine (Trileptal), felbamate (Felbatol), topiramate (Topamax), and primidone (Mysoline)
CNS stimulants (wakefulness promoting agents) like modafinil (Provigil)
Opioid pain medications like morphine (MS Contin, MSIR, Kadian, others)
Oral steroids such as prednisone (Deltasone), prednisolone (Prelone), methylprednisolone (Medrol), and dexamethasone (Decadron, Dexone)
Thyroid medications such as levothyroxine (Levoxyl, Levothroid, Synthroid)
Asthma medications such as theophylline (Theobid, Theo-Dur) and zafirlukast (Accolate)
Vitamin C
Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil) and naproxen (Naprosyn, Aleve)
Angiotensin-converting enzyme (ACE) inhibitors such as enalapril (Vasotec), benazepril (Lotensin), and lisinopril (Prinivil, Zestril)
Antihypertensives like eplerenone (Inspra)
Angiotensin II antagonists such as losartan (Cozaar), irbesartan (Avapro), and valsartan (Diovan)
Water pills (diuretics) such as spironolactone (Aldactone), amiloride (Midamor), and triamterene (Dyrenium)
Cancer medications like methotrexate (Trexall)
Antimalarials like pyrimethamine (Daraprim)
Anti-rheumatic drugs like sulfasalazine (Azulfidine)
Potassium supplements
Folate supplements

The above list may not include all the possible interactions of drospirenone and ethinyl estradiol. Give your doctor or pharmacist a complete list of your medications, including prescription drugs, over-the-counter medicines, dietary supplements, and herbal remedies. Also, tell your healthcare provider if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription medicines.

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