Drospirenone/Estradiol Side Effects

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Drospirenone/Estradiol - for the Consumer

Drospirenone/Estradiol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Drospirenone/Estradiol:

Back pain; breast tenderness, pain, or enlargement; headache; mild hair loss; nausea; nervousness; stomach cramps, bloating, or pain; vaginal spotting or breakthrough bleeding; vomiting; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or tenderness; chest pain; confusion; discharge from the nipples; fainting; irregular heartbeat; lumps in the breast; mental or mood changes (eg, depression, irritability, memory loss); numbness of an arm or leg; one-sided weakness; severe or persistent dizziness or stomach pain; severe or persistent breast pain; severe, persistent, or recurring abnormal vaginal bleeding; speech changes (eg, slurred speech); sudden severe headache, nausea, or vomiting; sudden shortness of breath; sudden weight gain; swelling of the hands or feet; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes.

Side Effects by Body System

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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