Yasmin

DRUG DESCRIPTION

Yasmin (drospirenone/ethinyl estradiol) tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below:

  • 21 yellow tablets each containing 3 mg DRSP and 0.03 mg EE
  • 7 inert white tablets

The inactive ingredients in the yellow tablets are lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 NF, magnesium stearate NF, hypromellose USP, macrogol 6000 NF, titanium dioxide USP, talc USP, and ferric oxide pigment, yellow NF. The white inert film-coated tablets contain lactose monohydrate NF, corn starch NF, povidone 25000 NF, magnesium stearate NF, hypromellose USP, talc USP, and titanium dioxide USP.

Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.

Ethinyl estradiol (19-nor-17?-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2.

The structural formulas are as follows:

YASMIN (drospirenone/ethinyl estradiol) Structural Formula Illustration

What are the possible side effects of drospirenone and ethinyl estradiol (Ocella, Yasmin, Yaz)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • ...

Read All Potential Side Effects and See Pictures of Yasmin

What are the precautions when taking drospirenone and ethinyl estradiol (Yasmin)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or drospirenone; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, stroke, blood clots (such as in the legs, eyes, lungs), untreated/uncontrolled high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches/migraines, heart disease (such as heart attack,...

Read All Potential Precautions of Yasmin


Yasmin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, notify your doctor promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods).

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, pulmonary embolism, stroke, heart attack). Get medical help right away if you experience: sudden shortness of breath, chest/jaw/left arm pain, unusual sweating, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness).

Get medical help right away if any of these rare but serious side effects occur: lumps in the breast, severe stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as new/worsening depression, suicidal thoughts).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or drospirenone; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, stroke, blood clots (such as in the legs, eyes, lungs), untreated/uncontrolled high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches/migraines, heart disease (such as heart attack, chest pain), heart valve disease, irregular heartbeat, kidney problems, liver problems (such as liver tumor, active liver disease), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, high cholesterol or triglyceride (blood fat) levels, depression, swelling (edema), gallbladder problems, obesity.

If you have diabetes, this medication may make it harder to control your blood sugar level. Check your blood sugar level regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication or diet.

Tell your doctor if you just had or will be having major surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are taking hormonal birth control products. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

This medication passes into breast milk. This may affect milk production and may harm a nursing infant. Consult your doctor before breast-feeding.


Yasmin Patient Information Including Side Effects

Brand Names: Ocella, Yasmin, Yaz

Generic Name: drospirenone and ethinyl estradiol (Pronunciation: dro SPY re nown, ETH in il, ESS tra dy ol )

  • What is drospirenone and ethinyl estradiol (Yasmin)?
  • What are the possible side effects of drospirenone and ethinyl estradiol (Yasmin)?
  • What is the most important information I should know about drospirenone and ethinyl estradiol (Yasmin)?
  • What should I discuss with my healthcare provider before taking drospirenone and ethinyl estradiol (Yasmin)?
  • How should I take drospirenone and ethinyl estradiol (Yasmin)?
  • What happens if I miss a dose (Yasmin)?
  • What happens if I overdose (Yasmin)?
  • What should I avoid while taking drospirenone and ethinyl estradiol (Yasmin)?
  • What other drugs will affect drospirenone and ethinyl estradiol (Yasmin)?
  • Where can I get more information?

What is drospirenone and ethinyl estradiol (Yasmin)?

Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

The combination of drospirenone and ethinyl estradiol is used as contraception to prevent pregnancy. It is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills to prevent pregnancy.

This medication is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.

Drospirenone and ethinyl estradiol may also be used for other purposes not listed in this medication guide.

What are the possible side effects of drospirenone and ethinyl estradiol (Yasmin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes);
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • breast pain, tenderness, or swelling;
  • freckles or darkening of facial skin, increased hair growth, or loss of scalp hair;
  • changes in weight or appetite, swelling of your hands or feet;
  • problems with contact lenses;
  • vaginal itching or discharge; or
  • changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about drospirenone and ethinyl estradiol (Yasmin)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a heart valve disorder, breast or uterine cancer, abnormal vaginal bleeding, kidney or liver disease, an adrenal gland disorder, severe high blood pressure, migraine headaches, or a history of jaundice caused by birth control pills.

Related Drug Centers
  • Yasmin
  • Yaz


Related Drugs Index: