Aubra EQ®
(levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg
This combo pill has:
- Lower amount of estrogen
- Progestin called levonorgestrel, which has higher testosterone-like effects
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†Premenstrual Dysphoric Disorder (PMDD)-associated symptoms like moodiness and irritability
Aubra EQ®
(levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg
This combo pill has:
- Lower amount of estrogen
- Progestin called levonorgestrel, which has higher testosterone-like effects
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PLEASE SEE FULL PRESCRIBING INFORMATION FOR EACH PRODUCT, INCLUDING BOXED WARNINGS.
IMPORTANT RISK INFORMATION for combined oral contraceptives, including Aubra EQ® (levonorgestrel and ethinyl estradiol tablets, USP 0.1 mg/0.02 mg), Chateal EQ® (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Cyred EQ® (desogestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg), Tarina Fe 1/20 EQ® (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, 1 mg/20 mcg and 75 mg), Tarina® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, 1 mg/20 mcg and 75 mg), Tri-VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.180 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.250 mg/0.035 mg), Tri-VyLibra® Lo (norgestimate and ethinyl estradiol tablets, USP 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg), and VyLibra® (norgestimate and ethinyl estradiol tablets, USP 0.250 mg/0.035 mg).
WARNING: Do not use combined oral contraceptives (COCs) including Aubra EQ, Chateal EQ, Cyred EQ, Tarina Fe 1/20 EQ, Tarina 24 Fe, Tri-VyLibra, Tri-VyLibra Lo, and VyLibra if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from COCs, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
Please review the full Prescribing Information, including the Boxed Warning, and Patient Information for the combined oral contraceptives below:
What are combined oral contraceptives (COCs) used for?
COCs are prescription birth control pills used to prevent pregnancy.
How effective are COCs?
COCs are taken to prevent pregnancy, and when taken correctly, have a failure rate of approximately 1% per year (1 pregnancy per 100 women per year of use) when used without missing any pills. The average failure rate of large numbers of pill users is approximately 5% per year (5 pregnancies per 100 women per year of use) when women who miss pills are included. For most women oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take pills considerably increases the chances of pregnancy.
The effectiveness of Tarina 24 Fe to prevent pregnancy in women who are obese with a body mass index more than 35 kg/m2 has not been studied.
Do some COCs have other uses in addition to preventing pregnancy?
Yes. Tri-VyLibra is used for the treatment of moderate acne in women who are at least 15 years old who have started having periods, don't have a medical reason to avoid COCs, and want to use a COC for birth control.
Who should not take COCs?
Do not take COCs if you:
- smoke and are over 35 years of age
- had blood clots in your arms, legs, lungs, or eyes
- had a problem with your blood that makes it clot more than normal
- have certain heart valve problems or irregular heartbeat that increases your risk of blood clots
- had a stroke
- had a heart attack
- have high blood pressure that cannot be controlled by medicine
- have diabetes with kidney, eye, nerve, or blood vessel damage
- have certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision, or any migraine headaches if you are over 35 years of age
- have liver problems, including liver tumors
- take any hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood)
- have any unexplained vaginal bleeding
- had breast cancer or any cancer that is sensitive to female hormones
What else should I know about taking COCs?
Stop taking COCs if you have a blood clot, sudden vision problems, headaches with vision changes, or yellowing of the skin or eyes. Stop taking COCs at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of birth control (like condoms or spermicide) during this time period. You should not take COCs any earlier than 4 weeks after having a baby or if you are breastfeeding. If you are pre-diabetic or diabetic, your healthcare provider should monitor you while taking COCs. Your healthcare provider should evaluate any significant changes in headaches and irregular period bleeding.
What are the most serious risks of taking COCs?
COCs increase the risk of serious conditions, including blood clots, stroke, and heart attack. These serious conditions can cause permanent disability or death. Other possible serious risks include liver tumors, high blood pressure, and gallbladder problems. It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.
What are possible side effects of COCs?
The most common side effects reported by women taking COCs include acne, nausea/vomiting, bleeding changes, weight changes, breast tenderness, vaginal infections, difficulty wearing contact lenses, headaches, anxiety, and depression.
COCs are intended to prevent pregnancy. COCs do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs), such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
IMPORTANT RISK INFORMATION for Jasmiel® (drospirenone and ethinyl estradiol tablets, USP 3 mg/0.02 mg)
WARNING TO WOMEN WHO SMOKEDo not use Jasmiel if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
Please review the full Prescribing Information, including the Boxed Warning, and Patient Information here.
What is Jasmiel?
Jasmiel is a prescription birth control pill used to prevent pregnancy. It is also used to treat symptoms of premenstrual dysphoric disorder (PMDD) if you choose to use the pill for birth control. It is also used to treat acne in women who are at least 14 years old, have started having periods, and choose to use the pill for birth control. Jasmiel has not been evaluated for the treatment of premenstrual syndrome (PMS).
Who should not take Jasmiel?
Your healthcare provider will not give you Jasmiel if you:
- Ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
- Ever had a stroke
- Ever had a heart attack
- Have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
- Have an inherited problem with your blood that makes it clot more than normal
- Have high blood pressure that medicine can't control
- Have diabetes with kidney, eye, nerve, or blood vessel damage
- Ever had certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision
- Ever had breast cancer, which may be sensitive to female hormones
- Have liver disease, including liver tumors
- Take any hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood)
- Have kidney disease
- Have adrenal disease
- Smoke and are over 35 years old
- Are pregnant or suspect you are pregnant
What else should I know about taking Jasmiel?
Tell your healthcare provider if you take any daily medicines that can increase potassium levels, such as ibuprofen, diuretics, potassium supplements, ACE inhibitors, angiotensin-II receptor antagonists, heparin, or aldosterone antagonists. Stop taking Jasmiel if you have a blood clot, sudden vision problems, headaches with vision changes, or yellowing of the skin or eyes. Stop taking Jasmiel at least 4 weeks before major surgery; wait until at least 2 weeks after major surgery to restart Jasmiel. You should not take Jasmiel any earlier than 4 weeks after having a baby or if you are breastfeeding. If you are pre-diabetic or diabetic, your healthcare provider should monitor you while taking Jasmiel. Your healthcare provider should evaluate any significant changes in headaches and irregular bleeding.
What are the most serious risks of taking Jasmiel?
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 years. Women who use birth control pills with drospirenone (like Jasmiel) may have a higher risk of getting a blood clot. Other possible serious risks include high blood pressure, gallbladder problems, and liver tumors. It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.
What are possible side effects of Jasmiel?
The most common side effects reported by women taking birth control pills like Jasmiel include nausea, headache, bleeding changes, and breast tenderness.
Jasmiel is intended to prevent pregnancy. Birth control pills like Jasmiel do not protect you against HIV infection (AIDS) and other sexually transmitted diseases (STDs).
IMPORTANT RISK INFORMATION for Lyleq® (norethindrone tablets, USP 0.35 mg)
WARNING: Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
Please review the full Prescribing Information, including the Boxed Warning, and Patient Information here.
What is Lyleq?
Lyleq is a prescription birth control pill used to prevent pregnancy.
Who should not take Lyleq?
You should not take Lyleq if:
- there is any chance you may be pregnant
- you have breast cancer
- you have bleeding between your periods that has not been diagnosed
- you are taking certain drugs for epilepsy (seizures) or for tuberculosis
- you are hypersensitive or allergic to any component of Lyleq
- you have liver tumors, either benign or cancerous
- you have acute liver disease
What else should I know about taking Lyleq?
Stop taking Lyleq if you have new or worsening headaches. If you are pre-diabetic or diabetic, your healthcare provider should monitor you while taking Lyleq. You must take Lyleq at the same time every day or it may not protect against pregnancy. Tell your healthcare provider if you have belly pain while taking Lyleq, as this could be a sign of tubal pregnancy or cysts on the ovaries. Tell your healthcare provider if you take other daily medications, such as seizure medication, antibiotics, anti-HIV medications, or herbal products because sometimes these products make Lyleq less effective in preventing pregnancy.
What are the most serious risks of taking Lyleq?
Lyleq can increase the risk of serious conditions including tubal pregnancy and ovarian cysts.
What are possible side effects of Lyleq?
The most common side effects reported by women taking Lyleq include nausea, headache, bleeding changes, dizziness, and breast tenderness. Rarely, acne, weight gain, and unusual hair growth can occur.
Lyleq is intended to prevent pregnancy. Birth control pills like Lyleq do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
PRODUCT INFORMATION for EContra One-Step® (levonorgestrel tablet, 1.5 mg)
Please review the full Prescribing Information and Patient Information here.
What is EContra One-Step?
EContra One-Step is emergency contraception that helps prevent pregnancy after regular birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.
What EContra One-Step is not:
EContra One-Step will not work if you are already pregnant and will not affect an existing pregnancy.
When should I use EContra One-Step?
The sooner you take emergency contraception, the better it works. You should use EContra One-Step within 72 hours (3 days) after you have had unprotected sex. EContra One-Step is a backup or emergency method of birth control you can use when your regular birth control was used incorrectly or failed, or when you did not use any birth control.
When should I not use EContra One-Step?
EContra One-Step should not be used as a regular birth control method because it's not as effective as regular birth control. EContra One-Step should not be used if you are already pregnant because it will not work. EContra One-Step should not be used if you are allergic to levonorgestrel or any other ingredients in EContra One-Step.
What else should I know about taking EContra One-Step?
Ask a healthcare provider or pharmacist before using EContra One-Step if you are taking efavirenz (HIV medication), rifampin (tuberculosis treatment), or medication for seizures (epilepsy). These medications may reduce the effectiveness of EContra One-Step and increase your chance of becoming pregnant. Your healthcare provider may prescribe another form of emergency contraception that may not be affected by these medications.
What are possible side effects of EContra One-Step?
Commonly reported adverse reactions include period changes, abdominal pain, nausea/vomiting, tiredness, headache, dizziness, and breast pain. Contact your healthcare provider if you have severe abdominal pain.
EContra One-Step will not protect you from HIV infection (AIDS) and other sexually transmitted diseases (STDs).
You can report SUSPECTED ADVERSE REACTIONS by calling 1-855-888-2467 or reporting via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.