Drospirenone / estradiol Side Effects

Some side effects of drospirenone / estradiol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to drospirenone / estradiol: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking drospirenone / estradiol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using drospirenone and estradiol and call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, problems with vision, speech, or balance;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• confusion, unusual thoughts or behavior;

• abnormal vaginal bleeding;

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

• severe pain in your upper stomach spreading to your back, vomiting;

• itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• a breast lump.

Less serious side effects of drospirenone / estradiol may include:

• mild nausea or stomach pain, diarrhea;

• mild headache;

• irregular vaginal bleeding, spotting;

• breast pain or tenderness;

• weight gain, swelling in your hands or feet;

• mood changes; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to drospirenone / estradiol: oral tablet

Cardiovascular

Cardiovascular side effects have included deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke and increased blood pressure.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, abdominal pain, enlarged abdomen, and enlargement of hepatic hemangiomas.

Dermatologic

Dermatologic side effects have included chloasma or melasma, erythema multiforme, erythema nodosum, hemorrhagic resumption, loss of scalp hair, hirsutism, pruritus, and rash.

Nervous system

Nervous system side effects have included headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy and dementia.

Ocular

Ocular side effects have included retinal vascular thrombosis and intolerance to contact lenses.

Genitourinary

Genitourinary side effects have included breast tenderness, pain and enlargement, nipple discharge, galactorrhea, fibrocystic breast disease, breast cancer, vaginal hemorrhage, endometrial disorder, leukorrhea, breast pain, increase in size of leiomyomata, vaginitis, changes in vaginal bleeding pattern, abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, and endometrial cancer.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reactions including urticaria and angioedema.

Endocrine

Endocrine side effects have included reduced carbohydrate tolerance, hypocalcemia, and increased triglycerides.

Respiratory

Respiratory side effects have included upper respiratory infection, sinusitis, and exacerbation of asthma.

General

General side effects have included increase or decrease in weight, edema, flu syndrome, accidental injury, surgery, pain in extremity, and changes in libido.

Metabolic

Metabolic side effects have included aggravation of porphyria.

Musculoskeletal

Musculoskeletal side effects have included arthralgias, back pain and leg cramps

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