pharmacopeia
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/api/v1/drug/clomiphene

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Selective Estrogen Receptor Modulators.

Selective Estrogen Receptor

Indications

Sourced from openFDA
  • Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy.

Contraindications

Sourced from openFDA
  • Hypersensitivity Clomiphene citrate is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients. Pregnancy Clomiphene citrate use in pregnant women is contraindicated, as clomiphene citrate does not offer benefit in this population.contraindicated

Dosage & administration

Sourced from openFDA

General Considerations The workup and treatment of candidates for clomiphene citrate therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with clomiphene citrate only after careful diagnostic evaluation (see INDICATIONS AND USAGE ). The plan of therapy should be outlined in advance. Impediments to achieving the goal of therapy must be excluded or adequately treated before beginning clomiphene citrate. The therapeutic objective should be balanced with potential risks and discussed with the patient and others involved in the achievement of a pregnancy. Ovulation most often occurs from 5 to 10 days after a course of clomiphene citrate. Coitus should be timed to coincide with the expected time of ovulation. Appropriate tests to determine ovulation may be useful during this time. Recommended Dosage Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days. The dose should be increased only in those patients who do not ovulate in response to cyclic 50 mg clomiphene citrate. A low dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome (see WARNINGS ; Ovarian Hyperstimulation Syndrome ). The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle.

Warnings & precautions

Sourced from openFDA

Visual Symptoms Patients should be advised that blurring or other visual symptoms such as spots or flashes (scintillating scotomata) may occasionally occur during therapy with clomiphene citrate. These visual symptoms increase in incidence with increasing total dose or therapy duration. These visual disturbances are usually reversible; however, cases of prolonged visual disturbance have been reported with some occurring after clomiphene citrate discontinuation. The visual disturbances may be irreversible, especially with increased dosage or duration of therapy. Patients should be warned that these visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting. These visual symptoms appear to be due to intensification and prolongation of after-images. Symptoms often first appear or are accentuated with exposure to a brightly lit environment. While measured visual acuity usually has not been affected, a study patient taking 200 mg clomiphene citrate daily developed visual blurring on the 7th day of treatment, which progressed to severe diminution of visual acuity by the 10th day. No other abnormality was found, and the visual acuity returned to normal on the 3rd day after treatment was stopped. Ophthalmologically definable scotomata and retinal cell function (electroretinographic) changes have also been reported.

Adverse reactions

Sourced from openFDA

Clinical Trial Adverse Events. Clomiphene citrate, at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued. Adverse experiences reported in patients treated with clomiphene citrate during clinical studies are shown in Table 2 . Table 2. Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*) *Includes 498 patients whose reports may have been duplicated in the event totals and could not be distinguished as such. Also, excludes 47 patients who did not report symptom data. Adverse Event % Ovarian Enlargement 13.6 Vasomotor Flushes 10.4 Abdominal-Pelvic Discomfort/Distention/Bloating 5.5 Nausea and Vomiting 2.2 Breast Discomfort 2.1 Visual Symptoms 1.5 Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes Headache 1.3 Abnormal Uterine Bleeding 1.3 Intermenstrual spotting, menorrhagia The following adverse events have been reported in fewer than 1% of patients in clinical trials: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss. Patients on prolonged clomiphene citrate therapy may show elevated serum levels of desmosterol. This is most likely due to a direct interference with cholesterol synthesis.

Use in specific populations

Sourced from openFDA

Pregnancy Clomiphene citrate use in pregnant women is contraindicated, as clomiphene citrate does not offer benefit in this population. Available human data do not suggest an increased risk for congenital anomalies above the background population risk when used as indicated. However, animal reproductive toxicology studies showed increased embryo-fetal loss and structural malformations in offspring. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks to the fetus. (See PRECAUTIONS: Pregnancy ). Liver Disease. Clomiphene citrate therapy is contraindicated in patients with liver disease or a history of liver dysfunction (see also INDICATIONS AND USAGE and ADVERSE REACTIONS ). Abnormal Uterine Bleeding. Clomiphene citrate is contraindicated in patients with abnormal uterine bleeding of undetermined origin (see INDICATIONS AND USAGE ). Ovarian Cysts. Clomiphene citrate is contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome (see INDICATIONS AND USAGE and WARNINGS ). Other. Clomiphene citrate is contraindicated in patients with uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion such as pituitary tumor (see INDICATIONS AND USAGE ).

Pharmacokinetics

Sourced from openFDA
Metabolism
Based on early studies with 14 C-labeled clomiphene citrate, the drug was shown to be readily absorbed orally in humans and excreted principally in the feces. Cumulative urinary and fecal excretion of the 14 C averaged about 50% of the oral dose and 37% of an intravenous dose after 5 days.

Overdosage

Sourced from openFDA

Signs and Symptoms Toxic effects accompanying acute overdosage of clomiphene citrate have not been reported. Signs and symptoms of overdosage as a result of the use of more than the recommended dose during clomiphene citrate therapy include nausea, vomiting, vasomotor flushes, visual blurring, spots or flashes, scotomata, ovarian enlargement with pelvic or abdominal pain. (See CONTRAINDICATIONS : Ovarian Cyst .) Oral LD 50 . The acute oral LD 50 of clomiphene citrate is 1700 mg/kg in mice and 5750 mg/kg in rats. The toxic dose in humans is not known. Dialysis. It is not known if clomiphene citrate is dialyzable. Treatment In the event of overdose, appropriate supportive measures should be employed in addition to gastrointestinal decontamination.

Approval history

Sourced from openFDA
  • Dec 20, 1988ANDAANDA072196Granata Bio Corp
  • Aug 30, 1999ANDAANDA075528Cosette
  • Nov 8, 2024ANDAANDA216739Appco
  • Nov 12, 2024ANDAANDA216545Rubicon
  • Oct 3, 2025ANDAANDA219406Accord Hlthcare
  • Oct 17, 2025ANDAANDA219781Novitium Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,463 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Abortion Spontaneous1107.5%
  2. 2Drug Exposure During Pregnancy1077.3%
  3. 3Nausea875.9%
  4. 4Off Label Use815.5%
  5. 5Headache805.5%
  6. 6Exposure During Pregnancy745.1%
  7. 7Drug Ineffective654.4%
  8. 8Vomiting654.4%
  9. 9Fatigue584.0%
  10. 10Maternal Exposure During Pregnancy543.7%
  11. 11Diarrhoea533.6%
  12. 12Foetal Exposure During Pregnancy493.3%
  13. 13Pregnancy473.2%
  14. 14Insomnia463.1%
  15. 15Dizziness453.1%

Literature

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Recent PubMed references pinned to Clomiphene as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 258 ClinicalTrials.gov registrations naming Clomiphene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Clomiphene work?
Mechanism-of-action class: Selective Estrogen Receptor Modulators.
What is Clomiphene used for?
According to FDA labeling, Clomiphene carries indications including: Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Clomiphene?
Clomiphene is classified as Ovulation stimulants, synthetic, Estrogen Agonist/Antagonist, Selective Estrogen Receptor Modulators, Endocrine Activity Alteration, Increased GnRH Secretion, Stimulate Ovarian Follicular Phase, Stimulate Ovulation.
What are the brand names for Clomiphene?
Clomiphene is marketed under brand names including Clomid, Milophene.
What are the contraindications for Clomiphene?
Clomiphene labeling lists contraindications including: Hypersensitivity Clomiphene citrate is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients. Pregnancy Clomiphene citrate use in pregnant women is contraindicated, as clomiphene citrate does not offer benefit in this population.. Always consult the full prescribing information and a clinician.
Note. Data for clomiphene is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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