Clomiphene (Oral route)
Female Reproductive Agent
Uses of This Medicine:
Clomiphene 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.
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
- 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:
- 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:
- Breast enlargement; dizziness or lightheadedness; headache; mental depression; nausea or vomiting; nervousness; restlessness; tiredness; trouble in sleeping
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- 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
Proper Use of This Medicine:
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.
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- 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.
- For treating infertility:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- More common
- stomach or pelvic pain
- 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
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.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
- More common
- Hot flashes
- Less common or rare
- Breast discomfort
- dizziness or lightheadedness
- heavy menstrual periods or bleeding between periods
- mental depression
- nausea or vomiting
- trouble in sleeping
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014