Clomiphene Citrate

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used in men who are not able to produce enough testosterone (hypogonadism).

Clomiphene must be taken by mouth exactly as directed by your doctor in order to be most effective. It is important to follow your dosing schedule carefully.

The dosage is based on your medical condition and response to treatment. Do not take it more often or for a longer time than prescribed by your doctor. Long-term treatment with this medication is not recommended and should not be more than 6 cycles.

You may be directed to record your body temperature, perform ovulation tests, and properly time sexual intercourse for best results. Ask your doctor if you have any questions.

Stomach upset, bloating, abdominal/pelvic fullness, flushing ("hot flashes"), breast tenderness, headache, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 you have any serious side effects, including: abnormal vaginal bleeding, mental/mood changes.

Vision changes (such as blurred vision, seeing spots or flashes) may sometimes occur during clomiphene treatment, especially if you are exposed to bright light. These side effects usually go away a few days or weeks after treatment is stopped. However, in rare cases, vision changes may be permanent. Get medical help right away if any of the following occur: vision problems/changes, eye pain.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. This may occur during therapy or after treatment has been stopped. Get medical help right away if you develop any of the following side effects: severe pain/swelling in the lower abdomen (pelvic) area, sudden/rapid weight gain, nausea/vomiting, diarrhea, shortness of breath, decreased urination, pain/redness/swelling of the legs, chest pain, fast/irregular heartbeat.

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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: gonadorelin.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: vomiting, abdominal/pelvic pain, vision problems.

Do not share this medication with others.

Lab and/or medical tests (such as hormone levels, pelvic examination/ultrasound) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, contact your doctor promptly for further instructions. Do not double the dose to catch up unless your doctor directs you to do so.

Before taking clomiphene, tell your doctor or pharmacist if you are allergic to it; 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 medication, tell your doctor or pharmacist your medical history, especially of: ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome), abnormal vaginal bleeding, liver disease, uterus problems (such as uterine fibroids, endometriosis), thyroid/adrenal gland problems, tumor in the brain (pituitary tumor), high levels of fats/triglycerides in the blood.

Use of clomiphene may result in multiple births (such as twins, triplets). Consult your doctor for more details.

This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.