In the U.S.—

In Canada—

Other commonly used names are clomifene; clomifene citrate.

• Antiestrogen
• Diagnostic aid, hypothalamic-pituitary-gonadal axis function
• Diagnostic aid, ovarian function
• Infertility therapy adjunct

Clomiphene (KLOE-mi-feen) is used as a fertility medicine in some women who are unable to become pregnant.

Clomiphene probably works by changing the hormone balance of the body. In women, this causes ovulation to occur and prepares the body for pregnancy.

Clomiphene may also be used for other conditions in both females and males as determined by your doctor.

The following information applies only to female patients taking clomiphene. Check with your doctor if you are a male and have any questions about the use of clomiphene.

Clomiphene is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

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 clomiphene, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to clomiphene. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—There is a chance that clomiphene may cause birth defects if it is taken after you become pregnant. Stop taking this medicine and tell your doctor immediately if you think you have become pregnant while still taking clomiphene.

If you become pregnant as a result of using this medicine, there is a chance of a multiple birth (for example, twins, triplets) occurring.

Breast-feeding—It is not known if clomiphene passes into breast milk. However, this medicine stops milk from being produced.

Other 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 clomiphene, it is especially important that your health care professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Unusually large ovary or
• Cyst on ovary—Clomiphene may cause the cyst to increase in size

• Endometriosis—Inducing ovulation (including using clomiphene) may worsen endometriosis because the body estrogen level is increased; estrogen can cause growth of endometriosis implants

• Fibroid tumors of the uterus—Clomiphene may cause fibroid tumors to increase in size

• Inflamed veins due to blood clots—Clomiphene may make condition worse

• Liver disease (or history of)—Clomiphene may make any liver disease worse

• Mental depression—Existing depression may become worse because of hormone changes caused by clomiphene

• Unusual vaginal bleeding—Some irregular vaginal bleeding is a sign that the lining of the uterus is growing too much or is a sign of cancer of the uterus lining; these problems must be ruled out before clomiphene is used because clomiphene can make these conditions worse

Take this medicine only as directed by your doctor. If you are to begin on Day 5, count the first day of your menstrual period as Day 1. Beginning on Day 5, take the correct dose every day for as many days as your doctor ordered. To help you to remember to take your dose of medicine, take it at the same time every day.

Dosing—

The dose of clomiphene will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of clomiphene. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treating infertility:
    • Adults—50 milligrams (mg) a day for five days of a menstrual cycle. The treatment is usually started on the fifth day of your menstrual period. If you do not have menstrual cycles, you can begin taking your medicine at any time. If you do not become pregnant after the first course, your doctor may increase your dose a little at a time up to 250 mg a day. Your treatment may be repeated until you do become pregnant or for up to four treatment cycles.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. If you do not remember until it is time for the next dose, take both doses together; then go back to your regular dosing schedule. If you miss more than one dose, check with your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working and to check for unwanted effects.

At certain times in your menstrual cycle, your doctor may want you to use an ovulation prediction test kit. Follow your doctor's instructions carefully. Ovulation is controlled by luteinizing hormone (LH). LH is present in the blood and urine in very small amounts during most of the menstrual cycle but rises suddenly for a short time in the middle of the menstrual cycle. This sharp rise, the LH surge, usually causes ovulation within about 30 hours. A woman is most likely to become pregnant if she has intercourse within the 24 hours after detecting the LH surge. Ovulation prediction test kits are used to test for this large amount of LH in the urine. This method is better for predicting ovulation than measuring daily basal body temperature. It is important that intercourse take place at the correct time to give you the best chance of becoming pregnant.

There is a chance that clomiphene may cause birth defects if it is taken after you become pregnant. Stop taking this medicine and tell your doctor immediately if you think you have become pregnant while still taking clomiphene.

This medicine may cause blurred vision, difficulty in reading, or other changes in vision. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not clear-headed or able to see well. If these reactions are especially bothersome, check with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

When this medicine is used for a short time at low doses, serious side effects usually are rare. However, check with your doctor immediately if any of the following side effects occur:

• More common
  • Bloating;  stomach or pelvic pain 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common or rare
  • Blurred vision;  decreased or double vision or other vision problems;  seeing flashes of light;  sensitivity of eyes to light;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Hot flashes 
  
  

• Less common or rare
  • Breast discomfort;  dizziness or lightheadedness ;  headache;  heavy menstrual periods or bleeding between periods;  mental depression ;  nausea or vomiting;  nervousness ;  restlessness;  tiredness ;  trouble in sleeping 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, clomiphene is used in certain patients with the following medical conditions:

• Certain problems of the male sexual organs caused by pituitary or hypothalamus gland problems (diagnosis)
• Male infertility caused by low production of sperm
• Problems with the corpus luteum (mature egg)

For males taking this medicine for treatment of infertility caused by low sperm production:

• To help decide on the best treatment for your medical problem, tell your doctor:
  • if you have ever had any unusual or allergic reaction to clomiphene.
  • if you have any of the following medical problems:
    • Liver disease
    • Mental depression
    • Thrombophlebitis
• If you miss a dose of this medicine, take it as soon as possible. If you do not remember until it is time for the next dose, take both doses together; then go back to your regular dosing schedule. If you miss more than one dose, check with your doctor.
• It is important that your doctor check your progress at regular visits to find out if clomiphene is working and to check for unwanted effects.
• This medicine may cause vision problems, dizziness, or lightheadedness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not clear-headed or able to see well.
• Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. When this medicine is used for short periods of time at low doses, serious side effects usually are rare. However, check with your doctor if any of the following side effects occur:
  Less common or rare
  • Blurred vision; decreased or double vision or other vision problems; seeing flashes of light; sensitivity of eyes to light; yellow eyes or skin
• Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
  Less common or rare
  • Breast enlargement; dizziness or lightheadedness; headache; mental depression; nausea or vomiting; nervousness; restlessness; tiredness; trouble in sleeping

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.