Aviane

The most common side effects of birth control pills are:

• Spotting or bleeding between menstrual periods
• Nausea 
• Breast tenderness
• Headache 

These side effects are usually mild and usually disappear with time.

Less common side effects are:

• Acne
• Less sexual desire
• Bloating or fluid retention
• Blotchy darkening of the skin, especially on the face 
• High blood sugar, especially in women who already have diabetes
• High fat (cholesterol, triglyceride) levels in the blood
• Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
• Problems tolerating contact lenses
• Weight gain

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider if you or any family member has ever had:

• Breast nodules, fibrocystic disease of the breast, an abnormal breast X-ray or mammogram
• Diabetes
• Elevated cholesterol or triglycerides
• High blood pressure
• Migraine or other headaches or epilepsy
• Depression
• Gallbladder, liver, heart or kidney disease
• History of scanty or irregular menstrual periods

Women with any of these conditions should be checked often by their healthcare provider if they choose to use oral contraceptives. Also, be sure to inform your healthcare provider if you smoke or are on any medications.

Follow the instructions on your medication's label. 

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart this medicine after not taking it for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take this medicine if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);

• a blood-clotting disorder or circulation problems;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease or liver cancer;

• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

• a history of jaundice caused by pregnancy or birth control pills; or

• if you smoke and are over 35 years old.

To make sure birth control pills are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;

• high cholesterol or triglycerides, or if you are overweight;

• a history of depression;

• diabetes, underactive thyroid, gallbladder disease;

• seizures or epilepsy;

• a history of irregular menstrual cycles;

• tuberculosis; or

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

• Tell all of your health care providers that you take Aviane. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Certain drugs, herbal products, or health problems could cause Aviane to not work as well. Be sure your doctor knows about all of your drugs and health problems.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• Do not use in children who have not had their first menstrual period.
• If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.

Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

• Barrier Methods of Birth Control
• Birth Control Options (Types and Side Effects)
• Hormonal Methods of Birth Control
• Information on Birth Control Pills

Applies to ethinyl estradiol / levonorgestrel: oral tablet

Applies to ethinyl estradiol / levonorgestrel: oral tablet

Cardiovascular

Cardiovascular side effects of hypertension and edema have been attributed to the estrogen component of this combination product. Significant blood pressure increases generally occurred only in women receiving high-dose estrogen products (50 mcg or more of ethinyl estradiol or equivalent daily). Exogenous estrogens may exert cardioprotective effects due to favorable changes in lipid profiles, however, beneficial effects may be partially or completely offset by alterations in lipid profiles induced by exogenous progestins.[Ref]

Detailed information concerning the effects of oral contraceptive therapy on lipid metabolism is available in the Endocrine paragraph of this side effect monograph.

Early investigations of high dose estrogen combinations (50 mcg or more of ethinyl estradiol or equivalent daily) suggested that women may be at increased risk of cardiovascular complications (myocardial infarction, stroke, and vascular thrombosis, including venous thromboembolism). More recent investigations of low dose estrogen combinations have suggested that oral contraceptive use is not associated with an increased risk of serious cardiovascular complications in healthy non smoking women up to the age of 45. Oral contraceptive use for women aged 35 to 44 who smoke or who have preexisting systemic diseases that may affect the cardiovascular system is not recommended.

Some investigators have suggested that even low dose products may result in adverse lipid metabolism and a woman's cardiovascular risk factors should be assessed before a decision is made to use oral contraceptive combinations.

The frequency of both subarachnoid hemorrhage and thrombotic stroke has been increased in women taking oral contraceptive hormones, however, the risk of these effects with low dose formulations appear to be very small for young women without underlying cardiovascular disease or other risk factors.[Ref]

General

Women taking oral contraceptive combinations have experienced several noncontraceptive health benefits. These benefits have included protection against two malignant neoplasms (endometrial carcinoma and ovarian cancer). In addition, use of oral contraceptive combinations has decreased the frequency of benign breast tumors, the risk of ovarian cysts, the risk of ectopic pregnancy, menstrual irregularity, the incidences of iron deficiency anemia, dysmenorrhea, and pelvic inflammatory disease.

Many of the adverse effects experienced by women on oral contraceptive combination products are related to a relative excess or deficiency of the estrogen and progestin components of these formulations. The following categorizes many of the frequent adverse effects by relative excess or deficiency of these components.

Progestin Excess:

Acne, oily skin
Breast tenderness
Depression
Tiredness, fatigue
Hair loss
Hypertension
Increased appetite
Weight gain
Cholestatic jaundice

Progestin Deficiency:

Late breakthrough bleeding
Amenorrhea
Hypermenorrhea

Estrogen Excess:

Nausea
Headache
Melasma
Hypertension
Breast tenderness
Edema

Estrogen Deficiency:

Early/midcycle breakthrough bleeding
Increased spotting
Hypomenorrhea[Ref]

A number of studies have suggested that use of oral contraceptives decreased the risk of ovarian cancer. Specifically, the risk of epithelial ovarian cancers is decreased by 40%. The protection against ovarian cancer may last for 10 to 15 years after discontinuation of oral contraceptives. After long term use (12 years), the risk of ovarian cancer is decreased by as much as 80%.

The risk of endometrial cancer is decreased by approximately 50%. Protection may last for 15 years after discontinuation and may be greatest for nulliparous women who may be at higher risk for endometrial carcinoma than other women.

The incidence of hospitalization for pelvic inflammatory disease has been approximately 50% lower in women taking oral contraceptives. The reason for the decrease in the frequency (or severity) of pelvic inflammatory disease in women taking oral contraceptives has not been fully elucidated.

Some recent studies have suggested that the decrease in frequency of functional ovarian cysts reported with some older formulations may not occur in women taking newer low dose formulations.

One recent study (The Nurses' Health Study) has suggested that long term use of oral contraceptives is safe and does not adversely affect long term risk for mortality.[Ref]

Gastrointestinal

Nausea, a relatively common gastrointestinal side effect, has occurred in approximately 10% of treated women during the first cycles of therapy. Some early reports suggested an association between oral contraceptive use and gallbladder disease.[Ref]

Cases of oral contraceptive induced esophageal ulceration and geographic tongue have been reported rarely.

More recent studies have suggested that the risk of gallbladder disease is minimal.[Ref]

Oncologic

Oral contraceptive combinations have been studied extensively for oncologic side effects. A number of studies have examined a possible relationship between the use of oral contraceptives and the development of breast cancer. Many of the studies have reported conflicting results. A committee of the World Health Organization evaluated these studies and the risks of breast cancer and concluded that: "Numerous studies have found no overall association between oral contraceptive use and risk of breast cancer." In addition, the same committee also examined a possible relationship between oral contraceptive use and neoplasms of the uterine cervix and concluded that: "There are insufficient data to draw any firm conclusions regarding the effects of combined oral contraceptives on the risk of cervical adenocarcinoma."[Ref]

The World Health Organization committee also noted that some studies "have found a weak association between long-term use of oral contraceptives and breast cancer diagnosed before the age of 36, and perhaps up to the age 45....It is unclear whether this observed association is attributable to bias, the development of new cases of cancer, or accelerated growth of existing cancers."

The World Health Organization committee further concluded that there is no increased risk of breast cancer in women over the age of 45 who have previously taken oral contraceptives. In addition, studies suggest that use of oral contraceptives does not place specific groups of women (like those with a family history of breast cancer) at higher or lower risk, and variations in the hormonal content of oral contraceptives do not influence the risk of breast cancer.

In general, studies evaluating the potential risk of cervical cancer in patients taking oral contraceptives have been complicated by the large number of confounding factors which make investigations into the epidemiology of this neoplasm difficult. Some studies have suggested that women taking oral contraceptives are at increased risk of dysplasia, epidermoid carcinoma, and adenocarcinoma of the cervix. However, other studies have not found such an association.[Ref]

Endocrine

Endocrine effects have included complex alterations in plasma lipid profiles.[Ref]

All progestins which occur in commercially available oral contraceptive combinations have adverse effects on lipid profiles. These progestins exert antiestrogen and androgen effects and decrease HDL (and HDL2) cholesterol levels and increase LDL cholesterol levels. The estrogen component of oral contraceptive combinations exert opposing effects. Consequently, alterations in lipid profiles are related to the relative amount and potency of the specific estrogen and progestin in a given product. (Levonorgestrel exerts potent progestin, antiestrogen, and androgen effects.)[Ref]

Hepatic

The rate of death due to hepatocellular carcinoma in the United States has not changed during the last 25 years (a time during which use of oral contraceptive hormones has increased dramatically).

A committee of the World Health Organization has reported that in developing countries where hepatitis B virus infection and hepatocellular carcinoma are common, "short term use of oral contraceptives does not appear to be associated with an increased risk. Data on the effects of long term use are scarce."

A recent Italian case control study of women with hepatocellular carcinoma has suggested that the relative risk of hepatocellular carcinoma is 2.2 for oral contraceptive users compared to women who never used oral contraceptives.

A similar American case control study from 1989 also reported a strong association between oral contraceptive use and hepatocellular carcinoma but concluded that: "If this observed association is causal, the actual number of cases of liver cancer in the United States attributable to oral contraceptive use is small. Therefore, these findings do not have public health importance in the United States and other Western nations."[Ref]

Hepatic side effects have included focal nodular hyperplasia, intrahepatic cholestasis, liver cell adenomas, hepatic granulomas, hepatic hemangiomas and well differentiated hepatocellular carcinomas, which have been reported rarely in association with estrogen therapy and therapy with oral contraceptive combinations.[Ref]

Hematologic

Cases of venous thrombosis, pulmonary embolism (sometimes fatal), and arterial thrombosis have been reported rarely.

Previous thrombotic disease is considered a contraindication to use of oral contraceptive combinations.[Ref]

A hematologic concern has been the risk of thromboembolism associated with exogenous estrogens. Because the dose of exogenous estrogens is low in most commercially available preparations, the risk of thromboembolism is minimal for most women. Risk is greater in women who are over age 35, smoke, and/or with a history of previous thrombotic diseases. The incidence of venous thrombosis in women with inherited clotting defects has been greater and developed sooner (within the first six months to one year of therapy).[Ref]

Genitourinary

A common genitourinary side effect has been breakthrough bleeding and spotting, especially during the first several cycles of oral contraceptive use. Nonhormonal causes of such bleeding should be excluded. In addition, oral contraceptive use may cause conception delay.[Ref]

Some women have experienced oligomenorrhea and amenorrhea following termination or oral contraceptive use.[Ref]

Psychiatric

Psychiatric side effects have included depression and precipitation of panic disorder.[Ref]

Immunologic

Immunologic side effects have included rare cases of oral contraceptive induced systemic lupus erythematosus.[Ref]

Nervous system

Nervous system side effects have been rare. A case of chorea has been reported in association with oral contraceptives.[Ref]

Ocular

Ocular side effects have included rare cases of retinal thrombosis. In addition, the manufacturers of oral contraceptive products report that some patients have developed changes in contact lens tolerance.[Ref]

Respiratory

A case of fatal pulmonary venooclusive disease has been reported.[Ref]

Metabolic

Despite the potentially adverse effects of oral contraceptives on lipid levels and glucose tolerance, some investigators have suggested that young diabetic women without existing vascular disease or severe lipidemias may be candidates for low dose oral contraceptive combinations with appropriate clinical monitoring of patient response and tolerance.[Ref]

Metabolic side effects have resulted in altered carbohydrate metabolism. The suggested effect that oral contraceptive combinations may have on glucose tolerance has been varied. Decreased glucose tolerance has been observed, however, studies with low dose preparations have suggested that decreased glucose tolerance due to oral contraceptive combinations generally has been minimal.[Ref]

Some side effects of Aviane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

No information is available on the relationship of age to the effects of levonorgestrel and ethinyl estradiol combination in geriatric patients.

Pregnancy

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anagrelide
• Aprepitant
• Boceprevir
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Dabrafenib
• Darunavir
• Dexamethasone
• Donepezil
• Efavirenz
• Eliglustat
• Enzalutamide
• Fosaprepitant
• Fosphenytoin
• Glecaprevir
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Oxcarbazepine
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Clarithromycin
• Colesevelam
• Cyclosporine
• Delavirdine
• Efavirenz
• Eslicarbazepine Acetate
• Etoricoxib
• Fosamprenavir
• Ginseng
• Lamotrigine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Parecoxib
• Perampanel
• Prednisolone
• Rifapentine
• Ritonavir
• Roflumilast
• Rosuvastatin
• Rufinamide
• Selegiline
• Tacrine
• Telaprevir
• Tipranavir
• Troglitazone
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure), uncontrolled or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Depression, history of or
• Epilepsy, history of or
• Gallbladder disease, history of or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Migraine headache—May make these conditions worse.

• Diarrhea or
• Vomiting—May decrease the absorption of levonorgestrel and ethinyl estradiol combination in the body.