Clomiphene is a non-steroidal fertility medicine. It causes the pituitary gland to release hormones needed to stimulate ovulation (the release of an egg from the ovary).

Clomiphene is used to cause ovulation in women with certain medical conditions (such as polycystic ovary syndrome) that prevent naturally occurring ovulation.

Clomiphene may also be used for purposes not listed in this medication guide.

Do not use clomiphene if you are already pregnant.

You should not use clomiphene if you have: liver disease, unexplained abnormal vaginal bleeding, an uncontrolled adrenal gland or thyroid disorder, an ovarian cyst (unrelated to polycystic ovary syndrome), or if you are pregnant.

Before taking this medicine

You should not use clomiphene if you are allergic to it, or if you have:

• unexplained abnormal vaginal bleeding;

• an ovarian cyst that is not related to polycystic ovary syndrome;

• past or present liver disease;

• a pituitary gland or other brain tumor;

• an untreated or uncontrolled problem with your thyroid or adrenal gland; or

• if you are pregnant.

To make sure clomiphene is safe for you, tell your doctor if you have:

• endometriosis or uterine fibroids.

Do not use clomiphene if you are already pregnant. Talk to your doctor if you have concerns about the possible effects of this medicine on a new pregnancy.

Clomiphene can pass into breast milk and may harm a nursing baby. This medication may slow breast milk production in some women. Tell your doctor if you are breast-feeding a baby.

Using clomiphene for longer than 3 treatment cycles may increase your risk of developing an ovarian tumor. Ask your doctor about your specific risk.

Higher doses of clomiphene can also lead to visual disturbances, which may be irreversible, or a condition called ovarian hyperstimulation syndrome (OHSS). OHSS can be a life threatening condition. Symptoms include abdominal pain, bloating, nausea, weight gain, and trouble breathing.

Fertility treatment may increase your chance of having multiple births (twins, triplets). These are high-risk pregnancies both for the mother and the babies. Ask your doctor about this risk.

Use clomiphene exactly as directed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor will perform medical tests to make sure you do not have conditions that would prevent you from safely using clomiphene.

Clomiphene is usually taken for 5 days, starting on the 5th day of your menstrual period. Follow your doctor's instructions.

You will need to have a pelvic examination before each treatment cycle. You must remain under the care of a doctor while you are using this medicine.

You will most likely ovulate within 5 to 10 days after you take clomiphene. To improve your chance of becoming pregnant, you should have sexual intercourse while you are ovulating. Follow your doctor’s instructions regarding timed intercourse.

Your doctor may have you use over-the-counter ovulation tests or check your temperature each morning and record your daily readings on a chart. This will help you determine when you can expect ovulation to occur.

In most cases, clomiphene should not be used for more than 3-6 treatment cycles (3 ovulatory cycles). If ovulation occurs but you do not get pregnant after 3 treatment cycles, your doctor may stop treatment and evaluate your infertility further.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Ovulation Induction:

50 mg orally once a day for 5 days. Therapy should be initiated on or near the 5th day of the menstrual cycle, but may be started at any time in patients without recent uterine bleeding.

If ovulation occurs and pregnancy is not achieved, up to 2 additional courses of clomiphene 50 mg orally once a day for 5 days may be administered. Each subsequent course may be started as early as 30 days after the previous course and after pregnancy has been excluded.

Most patients ovulate following the first course of therapy. However, if the patient fails to ovulate, a second course of 100 mg/day for 5 days may be given as early as 30 days following the initial course. A third course of 100 mg/day for 5 days may be given after 30 days, if necessary.

You should not use clomiphene if you are allergic to it, or if you have:

• unexplained abnormal vaginal bleeding;

• an ovarian cyst that is not related to polycystic ovary syndrome;

• past or present liver disease;

• a pituitary gland or other brain tumor;

• an untreated or uncontrolled problem with your thyroid or adrenal gland; or

• if you are pregnant.

To make sure clomiphene is safe for you, tell your doctor if you have:

• endometriosis or uterine fibroids.

Do not use clomiphene if you are already pregnant. Talk to your doctor if you have concerns about the possible effects of this medicine on a new pregnancy.

Clomiphene can pass into breast milk and may harm a nursing baby. This medication may slow breast milk production in some women. Tell your doctor if you are breast-feeding a baby.

Using clomiphene for longer than 3 treatment cycles may increase your risk of developing an ovarian tumor. Ask your doctor about your specific risk.

Higher doses of clomiphene can also lead to visual disturbances, which may be irreversible, or a condition called ovarian hyperstimulation syndrome (OHSS). OHSS can be a life threatening condition. Symptoms include abdominal pain, bloating, nausea, weight gain, and trouble breathing.

Fertility treatment may increase your chance of having multiple births (twins, triplets). These are high-risk pregnancies both for the mother and the babies. Ask your doctor about this risk.

Call your doctor for instructions if you miss a dose of clomiphene.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may result in nausea, vomiting, hot flashes, blurring or spots in your vision, or abdominal pain.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

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

Some women using this medicine develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:

• stomach pain, bloating;

• nausea, vomiting, diarrhea;

• rapid weight gain, especially in your face and midsection;

• little or no urinating; or

• pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Stop using clomiphene and call your doctor at once if you have:

• pelvic pain or pressure, enlargement in your pelvic area;

• vision problems;

• seeing flashes of light or "floaters" in your vision;

• increased sensitivity of your eyes to light; or

• heavy vaginal bleeding.

Common clomiphene side effects may include:

• flushing (warmth, redness, or tingly feeling);

• breast pain or tenderness;

• headache; or

• breakthrough bleeding or spotting.

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.

Other drugs may interact with clomiphene, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Keep all appointments with your doctor and laboratory. Your doctor may order certain lab tests to check your body's response to clomiphene.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.