Medically reviewed by Drugs.com. Last updated on Feb 10, 2022.
Applies to the following strengths: 50 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Ovulation Induction
Initial course: 50 mg orally once a day for 5 days
- If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, this regimen should be started on or about the fifth day of the cycle
- Therapy may be started at any time in a patient with no recent uterine bleeding
Second course: If ovulation does not occur after the first course of therapy, a second course of 100 once a day for 5 days should be given
- This course may be started as early as early as 30 days after the previous one after precautions are taken to exclude pregnancy
- The dose should be increased only in patients who do not ovulate in response to cyclic 50 mg dose.
- When ovulation occurs at the 50 mg/day dose, there is no advantage to increasing the dose in subsequent treatment cycles.
- Increasing the dose or duration of therapy beyond 100 mg/day for 5 days is not recommended.
- The majority of patients who are going to ovulate will do so after the first course of therapy; if ovulation does not occur after 3 courses, further treatment is not recommended and the patient should be reevaluated.
Use: For the treatment of ovulatory dysfunction in women desiring pregnancy; this drug is indicated only in patients with demonstrated ovulatory dysfunction who meet the following conditions:
- Patients who are not pregnant
- Patients without ovarian cysts; should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome
- Patients without abnormal vaginal bleeding; if abnormal vaginal bleeding is present, evaluate to ensure that neoplastic lesions are not present
- Patients with normal liver function
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Liver disease or a history of liver dysfunction: Contraindicated
- Hypersensitivity to the active component or to any of the ingredients
- Liver disease or a history of liver dysfunction
- Abnormal uterine bleeding of undetermined origin
- Ovarian cysts or enlargement not due to polycystic ovarian syndrome
- Uncontrolled thyroid or adrenal dysfunction
- Presence of organic intracranial lesion such as pituitary tumor
Consult WARNINGS section for additional precautions.
Data not available
- Workup and treatment should be supervised by physicians experienced in management of gynecologic or endocrine disorders.
- Patients should use this drug only after careful diagnostic evaluation, including evaluation for exclusion of pregnancy, ovarian enlargement, or ovarian cyst formation, including evaluation between each treatment cycle.
- The lowest dose and duration of use is recommended, especially if unusual sensitivity to pituitary gonadotropin is suspected as in patients with polycystic ovary syndrome.
- Ovulation usually occurs from 5 to 10 days after a course of therapy; coitus should be timed to coincide with the expected time of ovulation.
- Once ovulation is established, each course should be started on or about the fifth day of the cycle.
- Appropriate tests used to determine time of ovulation may be useful.
- If 3 ovulatory responses occur, but pregnancy is not achieved, further treatment is not recommended; if menses does not occur after an ovulatory response, the patient should be reevaluated.
- Long-term cyclic therapy is not recommended beyond a total of about 6 cycles.
- The manufacturer product information should be consulted.
- Protect from heat, light, and excessive humidity; store in closed containers.
- Patients most likely to achieve success from therapy with this drug include patients with polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.
- Patients selected for treatment with this drug should be evaluated in regard to estrogen levels, primary pituitary or ovarian failure, endometriosis and endometrial carcinoma, other impediments to pregnancy, and uterine fibroids.
- Genitourinary: Pelvic examination should occur prior to the first and each subsequent course of treatment.
- Metabolic: Periodic monitoring of plasma triglycerides in patients with preexisting or family history of hyperlipidemia should occur.
- Blurring or other visual symptoms may occur which may render activities such as driving or operating machinery more hazardous, particularly under conditions of variable lighting.
- Inform your healthcare provider of any abdominal or pelvic pain, weight gain, discomfort or distention.
- There is an increased risk of multiple pregnancy, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy.
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