Larin Fe 1/20

Note: This document contains side effect information about ethinyl estradiol / norethindrone. Some of the dosage forms listed on this page may not apply to the brand name Larin Fe 1 / 20.

Applies to ethinyl estradiol / norethindrone: oral capsule liquid filled, oral tablet, oral tablet chewable

Other dosage forms:

• oral tablet, oral tablet chewable

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

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 or lightheadedness
• fainting
• fast heartbeat
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• 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
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach pain
• sudden loss of coordination or slurred speech
• sweating
• troubled breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood

Some side effects of ethinyl estradiol / norethindrone 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
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside genitals
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

Applies to ethinyl estradiol / norethindrone: oral capsule, oral tablet, oral tablet chewable

The most frequently reported side effects were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, abdominal pain, mood changes, bacterial vaginitis, acne, irregular uterine bleeding, and weight gain.

Common (1% to 10%): Vaginal candidiasis, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal/irregular bleeding, metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage, breast pain, dysmenorrhea, vaginal hemorrhage, dysfunctional uterine bleeding

Frequency not reported: Ovarian vein thrombosis, vaginitis, amenorrhea, breakthrough bleeding, breast enlargement, breast secretion, cervical erosion changed, cervical secretion, menstrual flow changed, diminution in lactation, spotting, temporary infertility after discontinuation of treatment, premenstrual syndrome, uterine fibroid disease exacerbated

Postmarketing reports: Vaginal infection, pollakiuria, dysuria, ovarian cyst, pelvic pain, ovarian cyst rupture, pelvic fluid collection, nipple pain, nipple discharge, galactorrhea, fibrocystic breast change, breast disorder, breast mass, uterine leiomyomata size increased, cervical ectropion changed, endometrial hyperplasia, ovarian cyst, uterine enlargement

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

Frequency not reported: Deep vein thrombosis, myocardial infarction, hypertension, arterial thromboembolism, thrombophlebitis

Postmarketing reports: Coronary artery thrombosis, palpitation, tachycardia, angina pectoris, hot flush, heart rate irregular

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

Frequency not reported: Abdominal cramps, bloating, colitis, dyspepsia, inflammatory bowel disease, Crohn's disease, ulcerative colitis, mesenteric thrombosis

Postmarketing reports: Constipation, pancreatitis

Common (1% to 10%): Headache

Frequency not reported: Migraine, dizziness, cerebral hemorrhage, cerebral thrombosis

Postmarketing reports: Loss of consciousness, hyperesthesia, paresthesia, hypoesthesia, somnolence, sensory disturbance, transient ischemic attack, ischemic stroke, chorea, epilepsy exacerbated, dementia, hemiparesis

Frequency not reported: Hepatic adenoma, hepatic carcinoma, benign liver tumor

Postmarketing reports: Hemangioma of liver, breast cancer, ovarian cancer, endometrial cancer, uterine cancer

Postmarketing reports: Hypothyroidism, hyperthyroidism

Common (1% to 10%): Mood swing, depression, mood changed, anxiety

Frequency not reported: Nervousness

Postmarketing reports: Insomnia, suicidal ideation, panic attack, libido changed, homicidal ideation, dissociation, bipolar disorder, mood disturbed, irritability

Common (1% to 10%): Acne

Frequency not reported: Hirsutism, loss of scalp hair, melasma, chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, photosensitivity, pruritus

Postmarketing reports: Alopecia, generalized rash, allergic rash, skin discoloration, urticaria, angioedema, night sweats, angioedema, hirsutism, skin burning sensation, generalized erythema

Frequency not reported: Liver disease, gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome

Postmarketing reports: Cholelithiasis, cholecystitis

Frequency not reported: Hemolytic uremic syndrome

Postmarketing reports: Anemia

Postmarketing reports: Hypersensitivity reaction, anaphylactic/anaphylactoid reaction

Frequency not reported: Corneal curvature change/steepening, contact lens intolerance, cataracts, retinal thrombosis

Postmarketing reports: Vision blurred, vision impaired, corneal thinning, fungal infection, transient blindness

Frequency not reported: Pulmonary embolism

Postmarketing reports: Asthma exacerbated, dyspnea

Frequency not reported: Leg cramp, backache

Postmarketing reports: Myalgia, arthralgia, back pain

Common (1% to 10%): Weight fluctuation

Frequency not reported: Tolerance to carbohydrates reduced

Postmarketing reports: Appetite increased, appetite decreased, diabetes mellitus, hypoglycemia, hypocalcemia, triglycerides increased, blood glucose abnormal

Common (1% to 10%): Cervical smear abnormal, weight gain, edema

Frequency not reported: Fatigue, porphyria, Vitamin B6 deficient

Postmarketing reports: Weight decreased, peripheral edema, malaise, chest pain

Frequency not reported: Renal function impaired

Postmarketing reports: Cystitis-like syndrome