Estradiol & Dienogest

Estradiol/dienogest is a prescription medication used to prevent pregnancy. Estradiol/dienogest contains two medications, an estrogen (estradiol) and a progestin (dienogest) which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation, and by altering cervical mucus and the lining of the uterus. 

Estradiol/dienogest is the first four-phase oral contraceptive (birth control pill). Four-phasic means the doses of estrogen and progestin vary four times throughout each 28-day cycle.

This medication comes in a packet of 28 tablets. It is taken once daily, at the same time every day, for 28 days and then a new pack is started. Estradiol/dienogest tablets can be taken with or without food.

Common side effects include headaches, nausea, and spotting or bleeding between menstrual periods.

Estradiol/dienogest is a prescription medicine used to prevent pregnancy and to treat heavy monthly periods.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Estradiol & Dienogest may be found in some form under the following brand names:

• Alora

• Climara

• Climara Pro

• Climaval

• Clinagen LA 40

• Combipatch

• Delatestadiol

• Delestrogen

• Dep Androgyn

• Dep Gynogen

• Depo-Estradiol

• Depo-Testadiol

• Depotestogen

• Dioval 40

• Dioval XX

• Divigel

• Duo-Cyp

• Dura-Dumone

• Dura-Estrin

• Duragen

• Duratestrin

• Elestrin

• Elleste Solo

• Esclim

• Estra-C

• Estra-Testrin

• Estra-V 40

• Estrace

• Estraderm

• Estragyn LA 5

• Estrasorb

• Estring

• Estro-Cyp

• Estro-Span 40

• Estrogel

• Evamist

• Fempatch

• Femring

• Femtrace

• Gynodiol

• Gynogen LA 20

• Innofem

• Lunelle

• Medidiol 10

• Menaval-20

• Menostar

• Minivelle

• Natazia

• Oestrogel

• Prefest

• Progynova

• Sandrena

• Vagifem

• Valergen

• Vivelle-Dot

• Zumenon

Estradiol/dienogest, like other birth control pills can cause serious side effects including:

• Increased Risk of Blood Clots: Birth control pills increase the risk of serious blood clots in the legs, lungs, eyes, heart, and brain. Women who smoke, are obese, or over the age of 35, are at an increased risk. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.

• High Blood Pressure
• Gallbladder problems
• Liver Tumors

Call your healthcare provider right away if you have:

• Persistent leg pain
• Sudden shortness of breath
• Sudden blindness, partial or complete
• Severe pain in your chest
• Sudden, severe headache unlike your usual headaches
• Weakness or numbness in an arm or leg, or trouble speaking
• Yellowing of the skin or whites of the eyes

The most common side effects include:

• spotting or bleeding between menstrual periods
• nausea
• breast tenderness
• headache

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 levels in the blood
• depression, especially if you have had depression in the past
• problems tolerating contact lenses
• weight changes

​This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all medicines, both prescription and non-prescription, and herbal products that you take. Especially tell your doctor if you take:

• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR)
• phenytoin (Dilantin, Phenytek)
• rifampicin (Rifadin)
• St. John's wort 
• barbiturates such as butalbital (Fioricet, Fiorinal), phenobarbital (Luminal) and others
• bosentan (Tracleer)
• felbamate (Felbatol)
• griseofulvin
• oxcarbazepine (Trileptal)
• topiramate (Topamax)
• lamotrigine (Lamictal)
• protease inhibitors
• thyroid medications

​This is not a complete list of estradiol/dienogest drug interactions. Ask your doctor or pharmacist for more information.

• Estradiol/dienogest, like other birth control pills, increases the risk of blood clots, strokes, and heart attacks. See "FDA Warning".
• Estradiol/dienogest is used to prevent pregnancy. It does not protect against the spread of HIV, AIDs or other sexually transmitted diseases.
• Birth control pills increase the risk of liver tumors, both benign (non-cancerous) and cancerous.
• Estradiol/dienogest may worsen gallbladder disease.
• Estradiol/dienogest may also worsen depression.
• Estradiol/dienogest may affect your blood sugar levels, blood pressure, cholesterol, and menstrual bleeding patterns (periods).
• Estradiol/dienogest can cause changes to the eyes making it difficult to tolerate contact lenses.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of estradiol/dienogest there are no specific foods that you must exclude from your diet when taking this medication.

Before taking estradiol/dienogest, tell your doctor if you have:

• ever had breast cancer or any cancer that is sensitive to female hormones
• liver disease, including liver tumors
• ever had blood clots, a stroke, or a heart attack
• certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• an inherited problem with your blood that makes it clot more than normal
• high blood pressure that medicine can't control
• diabetes with kidney, eye, or blood vessel damage
• certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision

If any of these conditions happen for the first time while using estradiol/dienogest, stop taking estradiol/dienogest right away and talk to your healthcare provider. You should use non-hormonal contraceptive measures when you stop using estradiol/dienogest.

Also, do not take birth control pills if you:

• smoke and are over 35 years old
• are pregnant
• have any unexplained bleeding from the vagina
• have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy)

Estradiol/dienogest should not be used during pregnancy. Notify your doctor if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your doctor checks you to find out if you are pregnant. Stop taking estradiol/dienogest if you are pregnant.

If you wish to become pregnant you may stop taking estradiol/dienogest at any time. Talk to your doctor before you stop taking this medication.

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like estradiol/dienogest, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

• Take one pill every day at the same time. Take the pills in the order directed on the blister pack.
• When you finish a pack, start a new pack right away.
• This medication can be taken with or without food. Try taking it with food if it upsets your stomach.
• Make sure you talk to your doctor about what to do if you miss pills. Depending on how many pills you miss, you may have to use a backup method of birth control (condom) for 9 days.
• If you are less than 12 hours late taking your pill, take your pill as soon as you remember. Continue taking the next pills at your regular time. You do not need to use a backup method of birth control.
• If you are 12 hours late taking your pill, or if you vomit or have diarrhea within 4 hours of taking it, follow the directions for "what to do if you miss a pill".
• Spotting or breakthrough bleeding is normal. Talk to your doctor if bleeding persists.
• Do not skip any pills, even if you do not have sex often.

What to do if you miss a pill:

If you forgot to start a new blister pack, you may already be pregnant. Use back-up contraception (such as condoms and spermicides) anytime you have sex. Call your healthcare provider if you are unsure whether you are pregnant.

Do not take more than 2 pills in one day. On the days you take 2 pills to make up for missed pills, you may feel a little sick to your stomach (nauseous).

If you start vomiting or have diarrhea within 4 hours of taking your pill, take another pill of the same color from your extra blister pack.

If you are less than 12 hours late taking your pill:

• Take your pill as soon as you remember.
• Take the next pill at the usual time.
• You do not need to use back-up contraception.

If you miss ONE PILL for more than 12 hours:

• Days 1–17
  • Take your missed pill immediately.
  • Take your next pill at the usual time (you may have to take two pills that day).
  • Use back-up contraception for the next 9 days.
  • Continue taking one pill each day at the same time for the rest of your cycle.
• Days 18–24
  • Do not take any pills from your current blister pack and throw the pack away.
  • Take Day 1 pill from a new blister pack.
  • Use back-up contraception for the next 9 days.
  • Continue taking one pill from the new blister pack at the same time each day.
• Days 25–28
  • Take your missed pill immediately.
  • Take your next pill at the usual time (you may have to take two pills that day).
  • No back-up contraception is needed.
  • Continue taking one pill each day at the same time for the rest of your cycle.

If you miss TWO PILLS in a row:

• Days 1–17
  • if you miss the pills for Days 17 and 18, follow the instructions for Days 17–25 instead
  • Do not take the missed pills. Instead, take the pill for the day on which you first noticed you had missed pills.
  • Use back-up contraception for the next 9 days.
  • Continue taking one pill each day at the same time for the rest of your cycle.
• Days 17–25
  • if you miss the pills for Days 25 and 26, follow the instructions for Days 25–28 instead
  • Do not take any pills from your current blister pack and throw the pack away.
  • Take Day 3 pill from a new blister pack.
  • Use back-up contraception for the next 9 days.
  • Continue taking one pill from the new blister pack at the same time each day.

• Days 25–28
  • Do not take any pills from your current blister pack and throw the pack away.
  • Start a new pack on the same day or start a new pack on the day you usually start a new pack.
  • No back-up contraception is needed.
  • Continue taking one pill from the new pack at the same time each day, for the rest of your cycle.

You may already be pregnant or COULD BECOME PREGNANT if you had sex on the days after the pills were missed. The more pills missed and the closer they are to the end of the cycle, the higher the risk of a pregnancy. You should call your doctor or healthcare provider if you are unsure whether you are already pregnant.

If you are still not sure of what to do about the pills you have missed:

• Call your healthcare provider
• Use back-up contraception (such as condoms and spermicides) anytime you have sex and keep taking 1 pill each day

The recommended estradiol/dienogest dosage is one tablet taken once daily.

If you start taking estradiol/dienogest and you did not use a hormonal birth control method before:

• Take the first dark yellow pill on the first day (Day 1) of your natural menstrual cycle. The first day of your menstrual cycle is the first day you start spotting or bleeding.
• Use non-hormonal back-up contraception such as a condom and spermicide for the first 9 days that you take estradiol/dienogest.

If you start taking estradiol/dienogest and you are switching from a combination hormonal method such as:

• another pill
• vaginal ring
• patch

• Take the first dark yellow pill on the first day of your period. Do not continue taking the pills from your previous birth control pack. If you do not have a period, contact your healthcare provider before you start estradiol/dienogest.
• If you previously used a vaginal ring or transdermal patch, you should start using estradiol/dienogest on the day the ring or patch is removed.
• Use a non-hormonal back-up method such as a condom and spermicide for the first 9 days you take estradiol/dienogest.

If you start taking estradiol/dienogest and you are switching from a progestin-only method such as a:

• progestin-only pill
• implant
• intrauterine system
• injection

• Take the first dark yellow pill on the day you would have taken your next progestin-only pill or on the day of removal of your implant or intrauterine system or on the day when you would have had your next injection.
• Use a non-hormonal back-up method such as a condom and spermicide for the first 9 days you take estradiol/dienogest.

If you take too much estradiol/dienogest call your doctor or local Poison Control Center, or seek emergency medical attention right away.

Each estradiol/dienogest blister pack has 28 pills in 4 rows of 7 pills each:

• 2 dark yellow pills with hormones, for Days 1 and 2
• 5 medium red pills with hormones for Days 3–7
• 17 light yellow pills with hormones for Days 8–24
• 2 dark red pills with hormones for Days 25 and 26
• 2 white pills without hormones for Days 27 and 28

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.