Mestranol / Norethindrone Side Effects
Medically reviewed by Drugs.com. Last updated on Mar 30, 2024.
Applies to mestranol / norethindrone: oral tablet.
Important warnings
This medicine can cause some serious health issues
- Smoking cigarettes while using this drug raises the chance of very bad heart and blood-related side effects.
This chance is raised with age (mainly in women older than 35 years of age).
It is also raised with the number of cigarettes smoked.
It is strongly advised not to smoke.
Do not use this drug if you smoke and are older than 35 years of age.
Serious side effects
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Coughing up blood.
- Shortness of breath.
- Chest pain or pressure.
- Very bad dizziness or passing out.
- Very upset stomach or throwing up.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Very bad headache.
- Low mood (depression).
- Feeling very tired or weak.
- Very bad belly pain.
- Swelling.
- Bulging eyes.
- Change in eyesight.
- Change in how contact lenses feel in the eyes.
- A lump in the breast, breast pain or soreness, or nipple discharge.
- Vaginal itching or discharge.
- Spotting or vaginal bleeding that is very bad or does not go away.
Other side effects
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling more or less hungry.
- Dizziness.
- Weight gain.
- Headache.
- Upset stomach or throwing up.
- Cramps.
- Bloating.
- Enlarged breasts.
- Breast soreness.
- Period (menstrual) changes. These include spotting or bleeding between cycles.
- This drug may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For healthcare professionals
Applies to mestranol/norethindrone: oral tablet.
General
The more commonly reported adverse effects of combined oral contraceptives include breakthrough bleeding/spotting, changes in menstrual flow, headache, dizziness, mood changes, nausea, vomiting, and breast pain.[Ref]
Cardiovascular
Combined Oral Contraceptives:
- Very rare (less than 0.01%): Aggravation of varicose veins
- Frequency not reported: Myocardial infarction, arterial thromboembolism, thrombophlebitis, hypertension, fluid retention, edema
Endocrine
Combined Oral Contraceptives:
- Common (1% to 10%): Breast pain, tenderness, enlargement, secretion
- Frequency not reported: Temporary infertility after discontinuation, premenstrual syndrome, diminution in lactation when given immediately postpartum
Genitourinary
Combined Oral Contraceptives:
- Very common (10% or more): Breakthrough bleeding/spotting
- Common (1% to 10%): Dysmenorrhea, change in menstrual flow, change in cervical ectropion and secretion, amenorrhea, vaginitis, including candidiasis[Ref]
Nervous system
Combined Oral Contraceptives:
- Very common (10% or more): Headache
- Common (1% to 10%): Dizziness
- Very rare (less than 0.01%): Exacerbation of chorea
- Frequency not reported: Cerebral hemorrhage, cerebral thrombosis, migraines
Metabolic
Combined Oral Contraceptives:
- Uncommon (0.1% to 1%): Changes in appetite (increase or decrease); changes in serum lipid levels (including hypertriglyceridemia)
- Rare (0.01% to 0.1%): Glucose intolerance
- Very rare (less than 0.01%): Exacerbation of porphyria, depressed serum folate levels
- Frequency not reported: Reduced carbohydrate tolerance, vitamin B6 deficiency; weight changes (increase or decrease)
Gastrointestinal
Combined Oral Contraceptives:
- Common (1% to 10%): Nausea, vomiting, abdominal pain
- Uncommon (0.1% to 1%): Abdominal cramps, bloating
- Very rare (less than 0.01%): Pancreatitis, ischemic colitis, gall bladder disease including gallstones
- Frequency not reported: Inflammatory bowel disease (Crohn's Disease, ulcerative colitis), dyspepsia, mesenteric thrombosis[Ref]
Hepatic
Combined Oral Contraceptives:
- Rare (0.01% to 0.1%): Cholestatic jaundice
- Frequency not reported: Budd-Chiari syndrome, hepatocellular injury (e.g., hepatitis, hepatic function abnormal), increased risk hepatic adenomas or benign liver tumors[Ref]
Oncologic
Combined Oral Contraceptives:
- Very rare (less than 0.01%): Hepatocellular carcinomas
- Frequency not reported: Breast cancer, cervical intraepithelial neoplasia[Ref]
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. Numerous studies have looked at the incidence of breast cancer and use of oral contraceptives. In a large, prospective cohort study (n=1.8 million; follow up 10.9 years), a small increased risk was reported in women using any hormonal contraceptive compared to women who had never used hormonal contraception. The absolute risk was reported as 1 extra breast cancer for every 7690 women using hormonal contraception for 1 year.[Ref]
Psychiatric
Combined Oral Contraceptives:
- Common (1% to 10%): Nervousness, mood changes (including depression), changes in libido
- Frequency not reported: Mental depression[Ref]
Immunologic
Combined Oral Contraceptives:
- Very rare (less than 0.01%): Exacerbation of systemic lupus erythematosus
Ocular
Combined Oral Contraceptives:
- Rare (0.01% to 0.1%): Intolerance to contact lenses
- Very rare (less than 0.01%): Optic neuritis, retinal vascular thrombosis
- Frequency not reported: Changes in corneal curvature (steepening), cataracts, retinal thrombosis[Ref]
Respiratory
Combined Oral Contraceptives:
- Frequency not reported: Pulmonary embolism
Renal
Combined Oral Contraceptives:
- Very rare (less than 0.01%): Hemolytic uremic syndrome
- Frequency not reported: Impaired renal function, cystitis-like syndrome
Dermatologic
Combined Oral Contraceptives:
- Common (1% to 10%): Acne
- Uncommon (0.1% to 1%): Rash, chloasma (melasma), hirsutism, alopecia
- Rare (0.01% to 0.1%): Erythema nodosum
- Very rare (less than 0.01%): Erythema multiforme
- Frequency not reported: Loss of scalp hair, hemorrhagic eruption, photosensitivity
Other
Combined Oral Contraceptives:
- Frequency not reported: Fatigue[Ref]
Hypersensitivity
Combined Oral Contraceptives:
- Rare (0.01% to 0.1%): Anaphylactic/anaphylactoid reactions, including very rare cases of urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
Musculoskeletal
Combined Oral Contraceptives:
- Frequency not reported: Muscle spasms, back pain
References
1. (1992) "Oral contraceptives and neoplasia. WHO Scientific Group." World Health Organ Tech Rep Ser, 817, p. 1-46
2. Cerner Multum, Inc. "Australian Product Information."
3. (2019) "Product Information. Necon 1/50 (mestranol-norethindrone)." Watson Pharmaceuticals
4. "Product Information. Ortho-Novum 1/35 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
5. Morch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard O (2017) "Contemporary hormonal contraception and the risk of breast cancer." N Engl J Med, 377, p. 2228-39
More about mestranol / norethindrone
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- During pregnancy
- Drug class: contraceptives
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Further information
Mestranol/norethindrone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.