Clomiphene citrate 50 mg Tablet, 10-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Estrogen Agonist/Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Clomiphene is used to induce ovulation (egg production) in women who do not produce ova (eggs) but wish to become pregnant (infertility). Clomiphene is in a class of medications called ovulatory stimulants. It works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and be released.
Read the full MedlinePlus article ↗- Clomiphene works by nudging your brain and pituitary gland to release more of the hormones that tell your ovaries to develop and release an egg. If your cycles are irregular or you...
- What exactly does clomiphene do, and how does it help me get pregnant?
- The most common things you might notice are hot flashes, bloating or pelvic discomfort, nausea, breast tenderness, and sometimes blurred vision or light sensitivity. Most of these...
- What side effects should I expect, and which ones should make me call my doctor?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.652 | $46.52 / 10 tablet |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clomiphene Citrate 50 mg 16729-0723-51 | Accord | 30 tablets | $4.652 | AB | Availability likely | — |
| MiloPhene 50 mg 35573-0470-30 | Burel | 30 tablets | $4.652 | AB | Availability likely | — |
| Clomiphene Citrate 50 mg 64980-0690-01 | RISING | 10 tablets | $4.652 | AB | Availability likely | — |
| Clomiphene citrate 50 mgthis 70954-0825-20 | ANI | 10 tablets | $4.652 | AB | Availability likely | — |
| Clomiphene Citrate 50 mg 72888-0213-08 | Advagen | 10 tablets | $4.652 | AB | Availability likely | — |
| Clomiphene Citrate 50 mg 83390-0107-09 | Cosette | 10 tablets | $4.652 | AB | Availability likely | — |
| Clomid 50 mg 00713-0885-09 | Cosette | 10 tablets | $16.743 | AB | Availability likely | +260% |
| Clomid 50 mg 50090-6500-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Clomiphene Citrate 50 mg 55801-0187-01 | Appco | 30 tablets | — | AB | FDA listed | — |
| Clomiphene Citrate 50 mg 31722-0541-32 | Camber | 10 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 70954-0825-20 You're viewing this | 10 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10) | $4.65 / ea | $46.52 | 2025-10-17 | Active |
| 70954-0825-30 | 30 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10) | $4.65 / ea | $139.57 | 2025-10-17 | Active |
This pack has the lowest per-ea cost of the 2 priced pack sizes ($4.65 NADAC).
Pack size FAQ
What quantity is in NDC 70954-0825-20?
What is the difference between NDC 70954-0825-20 and NDC 70954-0825-30?
What NDC number is used to bill for this package of Clomiphene citrate 50 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Clomiphene citrate tablets are 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 tablets therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.
Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of clomiphene citrate tablets should be started on or about the 5th day of the cycle.
Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.) Clomiphene citrate tablets are indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below: Patients who are not pregnant. Patients without ovarian cysts.
Clomiphene citrate tablets should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate tablets treatment. Patients without abnormal vaginal bleeding.
If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present. Patients with normal liver function. In addition, patients selected for clomiphene citrate tablets therapy should be evaluated in regard to the following: Estrogen Levels.
Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy. Primary Pituitary or Ovarian Failure.
Clomiphene citrate tablets therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders.
Endometrial biopsy should always be performed prior to clomiphene citrate tablets therapy in this population. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility.
Uterine Fibroids. Caution should be exercised when using clomiphene citrate tablets in patients with uterine fibroids due to the potential for further enlargement of the fibroids. There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate tablets in the treatment of male infertility.
In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of clomiphene citrate tablets is not known. Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiphene citrate tablets in conjunction with other ovulation-inducing drugs).
Similarly, there is no standard clomiphene citrate tablets regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate tablets are not recommended for these uses.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION General Considerations The workup and treatment of candidates for clomiphene clomiphene citrate tablets therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with clomiphene citrate tablets 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 tablets. 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 tablets.
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 tablets. 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.
If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, the regimen of 50 mg daily for 5 days should be started on or about the 5th day of the cycle. Therapy may be started at any time in the patient who has had no recent uterine bleeding. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.
If ovulation does not appear to occur after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one after precautions are taken to exclude the presence of pregnancy. Increasing the dosage 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 three courses of therapy, further treatment with clomiphene citrate tablets is not recommended and the patient should be reevaluated. If three ovulatory responses occur, but pregnancy has not been 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 six cycles (see PRECAUTIONS).
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity Clomiphene citrate tablets are contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients. Pregnancy Clomiphene citrate tablets 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 tablets 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 tablets are contraindicated in patients with abnormal uterine bleeding of undetermined origin (see INDICATIONS AND USAGE).
Ovarian Cysts. Clomiphene citrate tablets are contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome (see INDICATIONS AND USAGE and WARNINGS). Other.
Clomiphene citrate tablets are 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).
⚠️ Warnings ▾
WARNINGS 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 tablets. 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 tablets 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 afterimages.
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 tablet 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. A patient treated during clinical studies developed phosphenes and scotomata during prolonged clomiphene citrate tablets administration, which disappeared by the 32nd day after stopping therapy. Postmarketing surveillance of adverse events has also revealed other visual signs and symptoms during clomiphene citrate tablets therapy (see ADVERSE REACTIONS).
While the etiology of these visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have a complete ophthalmological evaluation carried out promptly. Ovarian Hyperstimulation Syndrome The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients receiving clomiphene citrate therapy for ovulation induction. OHSS may progress rapidly (within 24 hours to several days) and become a serious medical disorder.
In some cases, OHSS occurred following cyclic use of clomiphene citrate therapy or when clomiphene citrate was used in combination with gonadotropins. Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with OHSS. OHSS is a medical event distinct from uncomplicated ovarian enlargement.
The clinical signs of this syndrome in severe cases can include gross ovarian enlargement, gastrointestinal symptoms, ascites, dyspnea, oliguria, and pleural effusion. In addition, the following symptoms have been reported in association with this syndrome: pericardial effusion, anasarca, hydrothorax, acute abdomen, hypotension, renal failure, pulmonary edema, intraperitoneal and ovarian hemorrhage, deep venous thrombosis, torsion of the ovary, and acute respiratory distress. The early warning signs of OHSS are abdominal pain and distention, nausea, vomiting, diarrhea, and weight gain.
Elevated urinary steroid levels, varying degrees of electrolyte imbalance, hypovolemia, hemoconcentration, and hypoproteinemia may occur. Death due to hypovolemic shock, hemoconcentration, or thromboembolism has occurred. Due to fragility of enlarged ovaries in severe cases, abdominal and pelvic examination should be performed very cautiously.
If conception results, rapid progression to the severe form of the syndrome may occur. To minimize the hazard associated with occasional abnormal ovarian enlargement associated with clomiphene citrate tablets therapy, the lowest dose consistent with expected clinical results should be used. Maximal enlargement of the ovary, whether physiologic or a…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 * ) Adverse Event % Ovarian Enlargement
13.6 Vasomotor Flushes
10.4 Abdominal Pelvic Discomfort/Distention/Bloating
5.5 Nausea and Vomiting
2.2 Breast Discomfort
2.1Visual Symptoms Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
1.5 Headache
1.3Abnormal Uterine Bleeding Intermenstrual spotting, menorrhagia 1.3 * 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. 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 tablets therapy may show elevated serum levels of desmosterol. This is most likely due to a direct interference with cholesterol synthesis. However, the serum sterols in patients receiving the recommended dose of clomiphene citrate are not significantly altered.
Ovarian cancer has been infrequently reported in patients who have received fertility drugs. Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of clomiphene may increase the risk of a borderline or invasive ovarian tumor. Postmarketing Adverse Events The following adverse reactions have been identified during post approval use of clomiphene citrate tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: Fever, tinnitus, weakness Cardiovascular: Arrhythmia, chest pain, edema, hypertension, palpitation, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis Central Nervous System: Migraine headache, paresthesia, seizure, stroke, syncope Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus, urticaria Fetal/Neonatal Anomalies: Abnormal bone development: skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot (clubfoot), spine, and joints Cardiac abnormalities: septal heart defects, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, and coarctation of the aorta Chromosomal disorders: Downs syndrome Ear abnormalities and deafness Gastrointestinal tract abnormalities: cleft lip and palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele Genitalia abnormalities: hypospadias, cloacal exstrophy Lung tissue malformations Malformations of the eye and lens (cataract) Neoplasms: neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia Nervous system abnormalities: neural tube defects (anencephaly, meningomyelocele), microcephaly, and hydrocephalus Renal abnormalities: renal agenesis and renal dysgenesis Others: dwarfism, mental retardation Gastrointestinal: Pancreatitis Genitourinary: Endometriosis, ovarian cyst (ovarian enlargement or cysts could, as such, be complicated by adnexal torsion), ovarian hemorrhage, tubal pregnancy, uterine hemorrhage, reduced endometrial thickness Hepatic: Transaminases increased, hepa…
🔄 Drug Interactions ▾
DRUG INTERACTIONS Drug interactions with clomiphene citrate tablets have not been documented.
🤰 Pregnancy ▾
PREGNANCY Fetal Risk Summary Clomiphene citrate tablets use in pregnant women is contraindicated, as clomiphene citrate tablets treatment does not offer benefit in this population. Available human data do not suggest an increased risk for congenital anomalies above the background population risk. 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. Clinical Considerations To avoid inadvertent clomiphene citrate tablets administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs. Patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle.
The next course of clomiphene citrate tablets therapy should be delayed until these conditions have been excluded. Human data The available human data from epidemiologic studies do not show any apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly. However, due to the small number of cases of congenital anomalies occurring in clomiphene citrate treated women, these epidemiologic studies were only able to rule out large differences in risk.
The studies did not consider factors associated with female subfertility and were unable to adjust for other important confounders. In addition, available data do not support an increased rate of spontaneous abortion among subfertile women treated with clomiphene citrate for ovulation induction. Animal data Oral administration of clomiphene citrate to pregnant rats during organogenesis at doses of 1 to 2 mg/kg/day resulted in hydramnion and weak, edematous fetuses with wavy ribs and other temporary bone changes.
Doses of 8 mg/kg/day or more also caused increased resorptions and dead fetuses, dystocia, and delayed parturition, and 40 mg/kg/day resulted in increased maternal mortality. Single doses of 50 mg/kg caused fetal cataracts, while 200 mg/kg caused cleft palate. Following injection of clomiphene citrate 2 mg/kg to mice and rats during pregnancy, the offspring exhibited metaplastic changes of the reproductive tract.
Newborn mice and rats injected during the first few days of life also developed metaplastic changes in uterine and vaginal mucosa, as well as premature vaginal opening and anovulatory ovaries. These findings are similar to the abnormal reproductive behavior and sterility described with other estrogens and antiestrogens. In rabbits, some temporary bone alterations were seen in fetuses from dams given oral doses of 20 or 40 mg/kg/day during pregnancy, but not following 8 mg/kg/day.
No permanent malformations were observed in those studies. Also, rhesus monkeys given oral doses of 1.5 to 4.5 mg/kg/day for various periods during pregnancy did not have any abnormal offspring.
🆘 Overdosage ▾
OVERDOSAGE 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 tablets 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Action Clomiphene citrate tablet is a drug of considerable pharmacologic potency. With careful selection and proper management of the patient, clomiphene citrate tablets have been demonstrated to be a useful therapy for the anovulatory patient desiring pregnancy. Clomiphene citrate is capable of interacting with estrogen-receptor-containing tissues, including the hypothalamus, pituitary, ovary, endometrium, vagina, and cervix.
It may compete with estrogen for estrogen-receptor-binding sites and may delay replenishment of intracellular estrogen receptors. Clomiphene citrate initiates a series of endocrine events culminating in a preovulatory gonadotropin surge and subsequent follicular rupture. The first endocrine event in response to a course of clomiphene therapy is an increase in the release of pituitary gonadotropins.
This initiates steroidogenesis and folliculogenesis, resulting in growth of the ovarian follicle and an increase in the circulating level of estradiol. Following ovulation, plasma progesterone and estradiol rise and fall as they would in a normal ovulatory cycle. Available data suggest that both the estrogenic and antiestrogenic properties of clomiphene may participate in the initiation of ovulation.
The two clomiphene isomers have been found to have mixed estrogenic and antiestrogenic effects, which may vary from one species to another. Some data suggest that zuclomiphene has greater estrogenic activity than enclomiphene. Clomiphene citrate has no apparent progestational, androgenic, or antiandrogenic effects and does not appear to interfere with pituitary-adrenal or pituitary-thyroid function.
Although there is no evidence of a “carryover effect” of clomiphene citrate, spontaneous ovulatory menses have been noted in some patients after clomiphene citrate tablets therapy. Pharmacokinetics 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.
Mean urinary excretion was approximately 8% with fecal excretion of about 42%. Some 14 C label was still present in the feces 6 weeks after administration. Subsequent single-dose studies in normal volunteers showed that zuclomiphene (cis) has a longer half-life than enclomiphene (trans).
Detectable levels of zuclomiphene persisted for longer than a month in these subjects. This may be suggestive of stereo-specific enterohepatic recycling or sequestering of the zuclomiphene. Thus, it is possible that some active drug may remain in the body during early pregnancy in women who conceive in the menstrual cycle during clomiphene citrate tablets therapy.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clomiphene Citrate Tablets, USP 50 mg are round, off white, flat beveled tablets, debossed “N” on one side of the scoreline and debossed "825" on the other side, free from physical defects. They are supplied in cartons of 10 (NDC 70954-825-20) and cartons of 30 (NDC 70954-825-30). Store tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Protect from heat, light, and excessive humidity, and store in closed containers. Rx only All trademarks are the property of their respective owners. Distributed by: ANI Pharmaceuticals, Inc.
Baudette, MN 56623 Issued: 07/2025 LB4769-01
📋 Description ▾
DESCRIPTION Clomiphene Citrate Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C 26 H 28 ClNO • C 6 H 8 O 7 and a molecular weight of 598.09. It is represented structurally as: Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder.
It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white scored tablet contains 50 mg clomiphene citrate, USP.
The tablet also contains the following inactive ingredients: corn starch, pregelatinized starch, lactose monohydrate, magnesium stearate, and sucrose. FDA approved dissolution test specifications differ from USP. structure
💬 Information for Patients ▾
INFORMATION FOR PATIENTS The purpose and risks of clomiphene citrate tablets therapy should be presented to the patient before starting treatment. It should be emphasized that the goal of clomiphene citrate tablets therapy is ovulation for subsequent pregnancy. The physician should counsel the patient with special regard to the following potential risks: Visual Symptoms: Advise that blurring or other visual symptoms occasionally may occur during or shortly after clomiphene citrate tablets therapy.
It should be made clear to the patient that, in some instances, visual disturbances may be prolonged, and possibly irreversible, especially with increased dosage or duration of therapy. Warn that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting (see WARNINGS). The patient should be instructed to inform the physician whenever any unusual visual symptoms occur.
If the patient has any visual symptoms, treatment should be discontinued and complete ophthalmologic evaluation performed. Abdominal/Pelvic Pain or Distention: Ovarian enlargement may occur during or shortly after therapy with clomiphene citrate tablets. To minimize the risks associated with ovarian enlargement, the patient should be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort, or distention after taking clomiphene citrate tablets (see WARNINGS).
Metabolism Disorders: Cases of hypertriglyceridemia have been reported. Preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment with clomiphene citrate tablets are associated with a risk of hypertriglyceridemia. Periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia (see ADVERSE REACTIONS).
Pretreatment screening of triglyceride levels is recommended in patients initiating clomiphene citrate tablets therapy. Gastrointestinal Disorders: Cases of pancreatitis have been reported. Multiple Pregnancy: Inform the patient that there is an increased chance of multiple pregnancy, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy, when conception occurs in relation to clomiphene citrate tablets therapy.
The potential complications and hazards of multiple pregnancy should be explained. Spontaneous Abortion and Congenital Anomalies: Inform the patient that the available data suggest no increase in the rates of spontaneous abortion (miscarriage) or congenital anomalies with maternal clomiphene citrate tablets use compared to rates in the general population. During clinical investigation, the experience from patients with known pregnancy outcome (Table 1) shows a spontaneous abortion rate of 20.4% and stillbirth rate of 1.0%.
(See CLINICAL STUDIES). Among the birth anomalies spontaneously reported as individual cases since commercial availability of clomiphene citrate tablets, the proportion of neural tube defects has been high among pregnancies associated with ovulation induced by clomiphene citrate, but this has not been supported by data from population-based studies.