clomiphene (Rx)

Brand and Other Names:Clomid, Serophene
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 50mg

Treatment of Ovulatory Failure

50 mg PO qDay initially for 5 days

If no ovulation, treatment can be repeated as early as 30 days after previous therapy; exclude presence of pregnancy; use the lowest effective dose

Dosage can be increased to 100 mg only in patients who do not respond to first course; lower doses of 12.5-25 mg qDay may be administered in women sensitive to the drug or who consistently develop large ovarian cysts

Monitor

Reassess diagnosis after 3 courses if ovulation has not occurred or if menses does not occur following ovulatory response

Not used in children

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Interactions

Interaction Checker

and clomiphene

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • ospemifene

              ospemifene, clomiphene. Either increases effects of the other by pharmacodynamic synergism. Contraindicated.

            Serious - Use Alternative (0)

              Monitor Closely (1)

              • benazepril

                clomiphene, benazepril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.

              Minor (0)

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                Adverse Effects

                >10%

                Ovarian enlargement (14%)

                Vasomotor flushing (10%)

                1-10%

                Abdominal discomfort (6%)

                Blurred vision (1.5%)

                Breast discomfort (2%)

                Nausea/vomiting (2%)

                Postmarketing Reports

                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

                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, hepatitis, pancreatitis

                Musculoskeletal: Arthralgia, back pain, myalgia

                Neoplasms: Liver (hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma); breast (fibrocystic disease, breast carcinoma); endometrium (endometrial carcinoma); nervous system (astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess); ovary (luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma); trophoblastic (hydatiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin’s lymphoma, tongue carcinoma, bladder carcinoma)

                Psychiatric: Anxiety, irritability, mood changes, psychosis

                Visual disorders: Abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary or prolonged loss of vision, possibly irreversible

                Metabolism disorders: Hypertriglyceridemia

                Other: Leukocytosis, thyroid disorder

                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
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                Warnings

                Contraindications

                Pregnancy

                Liver disease or history of liver disease

                Undiagnosed abnormal uterine bleeding

                Uncontrolled thyroid or adrenal dysfunction

                Endometrial cancer

                Ovarian cysts not due to PCOS

                Presence of organic intracranial lesion, including pituitary tumor

                Cautions

                Careful attention should be given to selection of candidates for therapy; pelvic examination is necessary prior to treatment and before each subsequent course

                Uterine fibroids, pituitary or ovarian failure may occur

                Potential for multiple births, especially at 100 mg dosage

                Use should be supervised by a practitioner with training and thoroughly familiar with infertility problems and their management

                Risk of visual disturbance (like scotoma & photopsia); patients should be warned that visual symptoms may render activities such as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting; while etiology of visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have complete ophthalmological evaluation carried out promptly

                Cases of hypertriglyceridemia reported; preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment are associated with risk of hypertriglyceridemia; periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia; pretreatment screening of triglyceride levels is recommended in patients initiating therapy

                Cases of pancreatitis reported

                Prolonged use of clomiphene citrate tablets USP may increase risk of a borderline or invasive ovarian tumor

                Presence of organic intracranial lesion, including pituitary tumor

                Ovarian enlargement may be accompanied by abdominal distention or abdominal pain and generally regresses without treatment within days or weeks of discontinuing therapy; withhold therapy if ovaries are abnormally enlarged until size returns to pretreatment size; reduce dose and duration of future cycles

                Ovarian hyperstimulation syndrome

                • Ovarian hyperstimulation syndrome is a rare exaggerated response to ovulation induction therapy
                • May begin within 24 hours of treatment but may become severe 7 to 10 days after therapy
                • Symptoms may include abdominal distention discomfort, nausea, diarrhea, vomiting
                • Severe symptoms may include severe abdominal pain ascites, hypotension, anuria/oliguria
                • Treatment is primarily symptomatic, including analgesics, fluid and electrolyte management, and prevention of thromboembolic complications
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                Pregnancy & Lactation

                Pregnancy

                Use in pregnant women is contraindicated, as treatment does not offer benefit in this population; to avoid inadvertent 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 therapy should be delayed until these conditions have been excluded

                Available human data from epidemiologic studies do not show apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly

                Lactation

                It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk, caution should be exercised if drug is administered to a nursing woman; in some patients, therapy may reduce lactation

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Binds to estrogen receptors, induces ovulation by increase output of pituitary gonadotropins

                Pharmacokinetics

                Half-Life elimination: 5-7 days

                Onset: Within 5-10 days

                Peak plasma time 6.5 hours

                Bioavailability: Readily absorbed from GI tract

                Metabolism: Enterohepatically circulated

                Excretion: feces 37-51%; small amount in urine

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Serophene oral
                -
                50 mg tablet
                clomiphene citrate oral
                -
                50 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                clomiphene citrate oral

                CLOMIPHENE - ORAL

                (KLOE-mi-feen)

                COMMON BRAND NAME(S): Clomid, Serophene

                USES: This medication is used to treat infertility in women. It works by stimulating an increase in the amount of hormones that support the growth and release of a mature egg (ovulation). This medication is not recommended for women whose ovaries no longer make eggs properly (primary pituitary or ovarian failure).

                HOW TO USE: 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.Your dosage is based on your medical condition and response to therapy. 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.

                SIDE EFFECTS: 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 (e.g., 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 www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: 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 (e.g., 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 (e.g., 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 not known whether this drug passes into breast milk. This drug may reduce milk production. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: 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.

                OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, abdominal/pelvic pain, vision problems.

                NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., hormone levels, pelvic examination/ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: 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.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                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.

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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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                NC NOT COVERED – Drugs that are not covered by the plan.
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