Lutera Side Effects

Generic name: ethinyl estradiol / levonorgestrel

Medically reviewed by Drugs.com. Last updated on Feb 3, 2025.

Note: This document provides detailed information about Lutera Side Effects associated with ethinyl estradiol / levonorgestrel. Some dosage forms listed on this page may not apply specifically to the brand name Lutera.

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

Other dosage forms:

• oral tablet
• transdermal patch extended release

Serious side effects of Lutera

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:

Other side effects of Lutera

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:

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may also be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you had given birth within 4 weeks before you start using this medicine.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

You might have some light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using ethinyl estradiol and norgestrel combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of having cancer of the breast or your reproductive organs (eg, endometrium, ovaries, cervix). Talk with your doctor about this risk. Check with your doctor right away if you experience abnormal vaginal bleeding.

Check with your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

For healthcare professionals

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

General adverse events

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]

See also:

Frequently asked questions

• Opill OTC vs other birth control pills: What's the difference?

Further information

Lutera 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer