Applies to desogestrel / ethinyl estradiol: oral tablet.

Serious side effects

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

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness, lightheadedness, fainting
• fever
• hives or welts
• itching skin or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sudden troubled breathing
• sweating
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Other side effects

Some side effects of desogestrel / 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:

Incidence not known

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• feeling sad or empty
• irritability
• itching of the vagina or outside the genitals
• loss of interest or pleasure
• pain during sexual intercourse
• thick, white curd-like vaginal discharge without odor or with mild odor
• trouble wearing contact lenses

For Healthcare Professionals

Applies to desogestrel / ethinyl estradiol: oral tablet.

Genitourinary

Diminution of lactation may theoretically occur when this drug is given immediately postpartum.^[Ref]

Common (1% to 10%): Breast pain/tenderness, amenorrhea, irregular bleeding

Uncommon (0.1% to 1%): Breast enlargement/hypertrophy, metrorrhagia

Rare (0.01% to 0.1%): Vaginal/breast discharge, vaginal candidiasis

Frequency not reported: Breakthrough bleeding, spotting, menstrual flow change, cervical ectropion and secretion, temporary infertility (after discontinuation), vaginitis, candidiasis, lactation diminution, premenstrual syndrome, dysmenorrhea, endometriosis, uterine myoma^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain

Uncommon (0.1% to 1%): Vomiting, diarrhea

Frequency not reported: Gallbladder disease, mesenteric thrombosis, gastrointestinal symptoms (e.g., abdominal pain, cramps, bloating), pancreatitis, colitis, Crohn's disease, ulcerative colitis^[Ref]

Psychiatric

Common (1% to 10%): Depressed mood, altered mood

Uncommon (0.1% to 1%): Decreased libido, nervousness

Rare (0.01% to 0.1%): Increased libido

Frequency not reported: Depression/mental depression^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Migraine

Frequency not reported: Stroke, transient ischemic attack, cerebral hemorrhage/thrombosis, chorea exacerbation, Sydenham's chorea, epilepsy^[Ref]

Metabolic

Common (1% to 10%): Increased weight

Uncommon (0.1% to 1%): Fluid retention

Rare (0.01% to 0.1%): Decreased weight

Frequency not reported: Decreased serum folate, porphyria exacerbation, decreased carbohydrate tolerance, increased/decreased folate^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash/allergic rash, urticaria, acne

Rare (0.01% to 0.1%): Erythema nodosum/multiforme, pruritus, alopecia, hirsutism

Frequency not reported: Scalp hair loss, melasma/chloasma or persistent melasma/chloasma, gestational herpes gestationis, hemorrhagic eruption^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypertension, fluid retention/edema

Rare (0.01% to 0.1%): Arterial/venous thromboembolism

Frequency not reported: Myocardial infarction, venous thrombosis, arterial/venous thromboembolic disorders, varicose vein aggravation, thrombophlebitis and venous thrombosis with/without embolism^[Ref]

Ocular

Rare (0.01% to 0.1%): Contact lens intolerance, cataract

Frequency not reported: Retinal thrombosis, optic neuritis, partial/complete vision loss, corneal curvature change/steepening^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity

Frequency not reported: Anaphylactic/anaphylactoid reactions, hereditary angioedema/angioedema, severe reactions with respiratory and circulatory symptoms^[Ref]

Other

Rare (0.01% to 0.1%): Otosclerosis^[Ref]

Hepatic

Frequency not reported: Cholestatic jaundice, Budd-Chiari syndrome, acute/chronic liver function disturbances, liver tumors/hepatic adenomas or benign liver tumors^[Ref]

Oncologic

Frequency not reported: Hormone-dependent tumors, breast cancer^[Ref]

Renal

Frequency not reported: Cystitis-like syndrome, impaired renal function^[Ref]

Respiratory

Frequency not reported: Pulmonary embolism^[Ref]

Hematologic

Frequency not reported: Hemolytic uremic syndrome^[Ref]

Musculoskeletal

Frequency not reported: Systemic lupus erythematosus^[Ref]