Note: This document contains side effect information about ethinyl estradiol / norethindrone. Some dosage forms listed on this page may not apply to the brand name Alyacen 1/35.
Applies to ethinyl estradiol / norethindrone: oral capsule liquid filled, oral tablet, oral tablet chewable. Other dosage forms:
- oral tablet, oral tablet chewable
Warning
Oral route (Tablet)
Junel®, Loestrin®, Microgestin®, Tri-Legest®: Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.Femhrt®: Estrogen alone or with a progestin should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke, DVT, pulmonary embolism, myocardial infarction, and invasive breast cancer have been reported with estrogen plus progestin therapy. Increased risks of stroke and DVT have been reported with estrogen-alone therapy, along with increased risk for endometrial cancer in a woman with a uterus who uses unopposed estrogens. An increased risk of probable dementia in postmenopausal women aged 65 and older has been reported with estrogen alone and with estrogen plus progestin therapy. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration possible.
Serious side effects of Alyacen 1/35
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
Other side effects of Alyacen 1/35
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
For Healthcare Professionals
Applies to ethinyl estradiol / norethindrone: oral capsule, oral tablet, oral tablet chewable.
General
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.[Ref]
Genitourinary
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[Ref]
Cardiovascular
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[Ref]
Gastrointestinal
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[Ref]
Nervous system
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[Ref]
Oncologic
Frequency not reported: Hepatic adenoma, hepatic carcinoma, benign liver tumor
Postmarketing reports: Hemangioma of liver, breast cancer, ovarian cancer, endometrial cancer, uterine cancer[Ref]
Endocrine
Postmarketing reports: Hypothyroidism, hyperthyroidism[Ref]
Psychiatric
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[Ref]
Dermatologic
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[Ref]
Hepatic
Frequency not reported: Liver disease, gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome
Postmarketing reports: Cholelithiasis, cholecystitis[Ref]
Hematologic
Frequency not reported: Hemolytic uremic syndrome
Postmarketing reports: Anemia[Ref]
Immunologic
Postmarketing reports: Hypersensitivity reaction, anaphylactic/anaphylactoid reaction[Ref]
Ocular
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[Ref]
Respiratory
Frequency not reported: Pulmonary embolism
Postmarketing reports: Asthma exacerbated, dyspnea[Ref]
Musculoskeletal
Frequency not reported: Leg cramp, backache
Postmarketing reports: Myalgia, arthralgia, back pain[Ref]
Metabolic
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[Ref]
Other
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[Ref]
Renal
Frequency not reported: Renal function impaired
Postmarketing reports: Cystitis-like syndrome[Ref]
