Note: This document contains side effect information about ethinyl estradiol / levonorgestrel. Some dosage forms listed on this page may not apply to the brand name Balcoltra.

Applies to ethinyl estradiol / levonorgestrel: oral tablet, oral tablet chewable. Other dosage forms:

• oral tablet
• transdermal patch extended release

Serious side effects of Balcoltra

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

Incidence not known

• Absent, missed, or irregular menstrual periods
• anxiety
• bloody stools
• blurred vision
• breast tenderness, enlargement, discharge
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• chest pain or discomfort
• chills
• clay-colored stools
• confusion
• cough
• dark or cloudy urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• difficult, burning, or painful urination
• difficulty in speaking
• dizziness or lightheadedness
• double vision
• dull ache or feeling of pressure or heaviness in the legs
• fainting
• fast heartbeat
• fever
• fluid-filled skin blisters
• frequent urge to urinate
• headache, severe and throbbing
• inability to move the arms, legs, or facial muscles
• inability to speak
• itching of the vagina or outside the genitals
• itching skin near damaged veins
• light vaginal bleeding between regular menstrual periods
• loss of appetite
• nausea
• nervousness
• pain during sexual intercourse
• pain or discomfort in the arms, jaw, back or neck
• pelvic pain
• pounding in the ears
• sensitivity to the sun
• skin thinness
• slow or fast heartbeat
• slow speech
• stomach bloating and cramping
• stomach pain and tenderness
• stopping of menstrual bleeding
• sweating
• swelling, pain, or tenderness in the upper abdominal area
• swollen feet and ankles
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thick, white curd-like vaginal discharge without odor or with mild odor
• troubled breathing
• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• yellow eyes or skin

Other side effects of Balcoltra

Some side effects of ethinyl estradiol/levonorgestrel 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

• Acne
• changes in appetite
• changes in weight
• decreased interest in sexual intercourse
• decreased milk production
• loss in sexual ability, desire, drive, or performance
• mental depression
• patchy brown or dark brown discoloration of the skin

For Healthcare Professionals

Applies to ethinyl estradiol / levonorgestrel: oral tablet, oral tablet chewable, transdermal film.

General

The most frequently reported side effects were headache, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changed, anxiety/panic attack, breast pain, and migraines.^[Ref]

Genitourinary

Very common (10% or more): Irregular/heavy uterine bleeding (up to 17%), menorrhagia (up to 11.6%), breast pain (up to 11.2%), dysmenorrhea (up to 11%), breakthrough bleeding/spotting

Common (1% to 10%): Breast tenderness/discomfort, vaginitis, candidiasis, breast enlargement, breast secretion, breast tension, intermenstrual bleeding/metrorrhagia

Uncommon (0.1% to 1%): Breast enlargement, breast hypertrophy, menstrual flow changed

Rare (less than 0.1%): Breast discharge, vaginal discharge, amenorrhea

Frequency not reported: Uterine myoma, temporary infertility, cervical erosion changed, cervical secretion changed, diminution in lactation

Postmarketing reports: Menstrual flow reduced, withdrawal bleeding missed, post pill amenorrhea^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Blood pressure increased

Rare (less than 0.1%): Venous thromboembolism, arterial thromboembolism

Frequency not reported: Deep vein thrombosis, hypertension, myocardial infarction, varicose veins exacerbated, thrombophlebitis, cerebral vascular disease, mitral valve prolapse

Postmarketing reports: Thrombosis^[Ref]

Nervous system

Very common (10% or more): Headache (up to 33%)

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

Very rare (less than 0.01%): Chorea exacerbated

Frequency not reported: Loss of consciousness, epilepsy, Sydenham's chorea, transient ischemic attack, ischemic stroke, hemorrhagic stroke, stroke, cerebral hemorrhage, cerebral thrombosis^[Ref]

Local

Common (1% to 10%): Application site disorder (transdermal system)

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 11%)

Common (1% to 10%): Abdominal pain/cramps, diarrhea

Very rare (less than 0.01%): Pancreatitis

Frequency not reported: Crohn's disease, ulcerative colitis, bloating, mesenteric thrombosis

Postmarketing reports: Abdominal distention^[Ref]

Oncologic

Rare (less than 0.1%): Benign liver tumor, malignant liver tumor, breast cancer^[Ref]

Hepatic

Rare (less than 0.1%): Cholestatic jaundice

Very rare (less than 0.01%): Gallbladder disease, gallbladder disease exacerbated

Frequency not reported: Cholecystitis, cholelithiasis, Budd-Chiari syndrome

Postmarketing reports: Liver function disturbance^[Ref]

Hematologic

Frequency not reported: Hemolytic uremic syndrome^[Ref]

Psychiatric

Common (1% to 10%): Mood changed, mood swings/alteration/affect lability, depression, anxiety/panic attack, nervousness, libido decreased, libido increased, depression

Frequency not reported: Major depressive disorder, suicide attempt, depressed mood, crying, major depression, affective disorder, depression suicidal, dysthymic disorder

Postmarketing reports: Insomnia^[Ref]

Immunologic

Rare (less than 0.1%): Hypersensitivity reaction, anaphylactic/anaphylactoid reaction

Very rare (less than 0.01%): Systemic lupus erythematosus exacerbated^[Ref]

Ocular

Rare (less than 0.1%): Contact lens intolerance

Very rare (less than 0.01%): Retinal vein thrombosis

Frequency not reported: Cataract, corneal curvature changed/steepening

Postmarketing reports: Optic neuritis^[Ref]

Metabolic

Common (1% to 10%): Appetite increased, fluid retention/edema

Uncommon (0.1% to 1%): Appetite decreased, serum lipid levels changed, hypertriglyceridemia

Rare (less than 0.1%): Glucose tolerance changed

Frequency not reported: Tolerance to carbohydrates reduced^[Ref]

Dermatologic

Common (1% to 10%): Acne

Uncommon (0.1% to 1%): Urticaria, rash, chloasma

Rare (less than 0.1%): Erythema nodosum, erythema multiforme, hereditary angioedema exacerbated

Frequency not reported: Herpes gestationis, hirsutism, alopecia, melasma

Postmarketing reports: Alopecia, itching, angioedema^[Ref]

Other

Common (1% to 10%): Weight gain, weight changed, flu syndrome

Rare (less than 0.1%): Weight decreased

Very rare (less than 0.01%): Porphyria exacerbated

Frequency not reported: Ectopic pregnancy, spontaneous abortion, porphyria, congenital anomaly, cystitis-like syndrome

Postmarketing reports: Chest pain, fatigue, malaise, edema peripheral, pain, serum folate decreased^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Frequency not reported: Systemic lupus erythematosus

Postmarketing reports: Muscle spasm, pain in extremity^[Ref]

Renal

Frequency not reported: Pulmonary embolism

Postmarketing reports: Pulmonary thrombosis^[Ref]