Note: This document contains side effect information about ethinyl estradiol / norgestrel. Some dosage forms listed on this page may not apply to the brand name Lo/Ovral.
Applies to ethinyl estradiol / norgestrel: oral tablet.
Warning
Oral route (Tablet)
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.
Serious side effects of Lo/Ovral
Along with its needed effects, ethinyl estradiol/norgestrel 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/norgestrel:
Incidence not known
- Absent, missed, or irregular menstrual periods
- backache
- belching
- bleeding between periods
- blurred vision
- breast tenderness, pain, enlargement, or secretion
- change in the amount of bleeding during periods
- change in the pattern of monthly periods
- changes in skin color, pain, tenderness, swelling of the foot or leg
- chest pain or discomfort
- chills
- clay-colored stools
- clear or bloody discharge from the nipple
- cough
- dark urine
- diarrhea
- difficulty swallowing
- dimpling of the breast skin
- dizziness
- dull ache or feeling of pressure or heaviness in the legs
- fast heartbeat
- fever
- full or bloated feeling or pressure in the stomach
- headache
- headache, severe and throbbing
- heartburn
- hives
- inability to speak
- indigestion
- inverted nipple
- itching of the vagina or genital area
- itching skin near damaged veins
- light vaginal bleeding between periods and after intercourse
- loss of appetite
- lump in the breast or under the arm
- nausea and vomiting
- nervousness
- pain during sexual intercourse
- pain or discomfort in the arms, jaw, back or neck
- persistent crusting or scaling of the nipple
- pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness or swelling of the breast
- seizures
- severe or sudden headache
- slow or fast heartbeat
- slurred speech
- sore on the skin of the breast that does not heal
- stomach discomfort, upset, or pain
- stopping of menstrual bleeding
- sweating
- swelling, pain, or tenderness in the upper abdominal area
- swollen feet and ankles
- temporary blindness
- thick, white vaginal discharge with no odor or with a mild odor
- tightness in the chest
- twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
- unpleasant breath odor
- unusual stopping of menstrual bleeding
- unusual tiredness or weakness
- vomiting of blood
- weakness in the arm or leg on one side of the body, sudden and severe
- yellow eyes or skin
Other side effects of Lo/Ovral
Some side effects of ethinyl estradiol / norgestrel 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 weight or appetite
- decreased interest in sexual intercourse
- inability to have or keep an erection
- increased hair growth, especially on the face
- intolerance to contact lenses
- loss in sexual ability, desire, drive, or performance
- loss of hair on the scalp
For Healthcare Professionals
Applies to ethinyl estradiol / norgestrel: oral tablet.
General
The frequency of the reported side effects is unknown, however, an increased risk of the following side effects has been associated with the use of oral contraceptives: thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis, hypertension, gallbladder disease, hepatic adenomas, carcinomas, or benign liver tumors.[Ref]
Genitourinary
Frequency not reported: Breakthrough bleeding, spotting, menstrual flow changed, amenorrhea, cervical erosion change, cervical secretion change, decreased lactation, vaginal candidiasis, premenstrual syndrome, cystitis-like syndrome, vaginitis, dysmenorrhea[Ref]
Gastrointestinal
Frequency not reported: Mesenteric thrombosis, nausea, vomiting, gastrointestinal symptoms, abdominal cramps, bloating, colitis, pancreatitis[Ref]
Oncologic
Frequency not reported: Hepatic adenoma, hepatic carcinoma, benign liver tumor, breast carcinoma, carcinoma of reproductive organs[Ref]
Cardiovascular
Frequency not reported: Thrombophlebitis, arterial thromboembolism, myocardial infarction, hypertension, cerebral-vascular disease with mitral valve prolapse, venous thrombosis, varicose veins aggravated[Ref]
Hematologic
Frequency not reported: Hemolytic uremic syndrome, sickle-cell disease, hemolytic uremic syndrome[Ref]
Endocrine
Frequency not reported: Temporary infertility following discontinuation, breast tenderness, breast enlargement, breast secretion[Ref]
Hepatic
Frequency not reported: Gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome[Ref]
Psychiatric
Frequency not reported: Depression, nervousness, libido changed, mood changed[Ref]
Immunologic
Frequency not reported: Anaphylactic/anaphylactoid reactions[Ref]
Other
Frequency not reported: Edema/fluid retention, weight increased, weight decreased, reduced tolerance to carbohydrates, corneal curvature steepening, contact lens intolerance, congenital anomaly, porphyria, serum folate decreased[Ref]
Nervous system
Frequency not reported: Cerebral hemorrhage, cerebral thrombosis, migraine, headache, dizziness, exacerbation of chorea[Ref]
Ocular
Frequency not reported: Retinal thrombosis, cataracts, optic neuritis[Ref]
Musculoskeletal
Frequency not reported: Lupus-like syndrome[Ref]
Metabolic
Frequency not reported: Appetite changed, glucose tolerance decreased, serum folate depressed[Ref]
Respiratory
Frequency not reported: Pulmonary embolism[Ref]
Renal
Frequency not reported: Renal function impaired[Ref]
Dermatologic
Frequency not reported: Melasma, allergic rash, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, acne, urticaria, angioedema[Ref]