Clomiphene
Clomiphene is an oral fertility medication used to treat ovulatory dysfunction (trouble ovulating) in women who are trying to become pregnant.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Clomiphene (Clomid) is an oral fertility medicine, on the market since the 1960s and available as a generic, and a long-familiar first step for women who are not ovulating and want to become pregnant; it competes with estrogen in the brain and pituitary gland, prompting the release of hormones that tell the ovaries to ripen and release an egg. Most women tolerate it reasonably well, and hot flashes, bloating, breast tenderness and headache are what people notice most. Stop it and call promptly for any vision change (blurring, spots, flashes) or for severe belly pain, swelling or rapid weight gain, which can signal ovarian hyperstimulation syndrome (dangerously enlarged ovaries).
Clinical pearls
- Ovulation usually follows several days after the last tablet, so timing intercourse to that window matters as much as the medicine.
- Expect a pelvic exam before each new cycle to check for ovarian enlargement or cysts before another course begins.
- Treatment is usually capped at about six cycles in total, so have a plan for next steps if pregnancy has not happened by then.
- If a period is late, take a pregnancy test before starting the next course, because clomiphene must not be taken during pregnancy.
Patient information guide A plain-language walkthrough of Clomiphene, written from its FDA label.
What Clomiphene is used for
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Clomiphene tablets are approved to treat ovulatory dysfunction — difficulty or failure to ovulate — in women trying to conceive. The following conditions are supported across the available products (Clomid, Clomiphene citrate, and MiloPhene):
- Polycystic ovary syndrome (PCOS)
- Amenorrhea-galactorrhea syndrome (absent periods combined with breast milk production)
- Psychogenic amenorrhea (absent periods linked to psychological causes)
- Post-oral-contraceptive amenorrhea (absent periods after stopping birth control pills)
- Certain cases of secondary amenorrhea of undetermined cause
Clomiphene is not recommended for use alongside other ovulation-inducing drugs, for IVF programs, or for treating male infertility — there is no adequate evidence to support these uses.
How Clomiphene works
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Clomiphene binds to estrogen receptors in the hypothalamus and pituitary gland — the brain structures that control reproductive hormones. By blocking estrogen's normal feedback signal, it tricks the pituitary into releasing more follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This hormonal surge stimulates the ovaries to develop a follicle and release an egg, triggering ovulation and the normal rise of estrogen and progesterone that follows.
Clomiphene has both estrogen-like and anti-estrogen properties, and both appear to play a role in triggering ovulation. It does not have progestational, androgenic, or anti-androgenic effects, and it does not appear to interfere with thyroid or adrenal function.
Clomiphene dosage
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Clomiphene tablets are taken by mouth once daily for 5 days each treatment cycle. Your prescriber will advise you on exactly when in your cycle to begin, and timing intercourse to coincide with expected ovulation — typically 5 to 10 days after finishing the course — is important. Dosing starts low and may be cautiously increased if ovulation does not occur; your doctor will guide any adjustments. Treatment is generally limited to about six total cycles, including three ovulatory cycles.
- Take exactly as prescribed — do not increase your own dose
- A pelvic exam and pregnancy check are required before each new cycle begins
- If you miss a dose, contact your prescriber for guidance rather than doubling up
Dosing details from the FDA-approved label
From the Clomiphene prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Treatment of the selected patient (initial course)
- 50 mg daily (1 tablet) for 5 days
- Started on or about the 5th day of the cycle if progestin-induced bleeding is planned or spontaneous uterine bleeding occurs prior to therapy
- May be started at any time in a patient who has had no recent uterine bleeding
- 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
- Patients who do not appear to ovulate after the first course of therapy (second course)
- 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days
- May be started as early as 30 days after the previous course after precautions are taken to exclude pregnancy
- Maximum: Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended
- If ovulation does not occur after three courses, further treatment is not recommended and the patient should be reevaluated; long-term cyclic therapy is not recommended beyond a total of about six cycles
Read the label’s full dosing text
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.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Clomiphene side effects
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Clomiphene is generally well tolerated at recommended doses, and most side effects are mild and go away after treatment ends. Common side effects include:
Common side effects
- Ovarian enlargement
- Hot flashes (vasomotor flushes)
- Abdominal or pelvic discomfort, bloating
- Nausea and vomiting
- Breast tenderness or discomfort
- Visual disturbances (blurred vision, floaters, light sensitivity)
- Headache
- Abnormal uterine bleeding or spotting
- Irregular or abnormal uterine bleeding
When to get medical help
- Call your doctor right away if you notice any changes in vision — blurring, spots, or flashes — and stop taking clomiphene until you've been evaluated
- Seek immediate medical help for severe abdominal or pelvic pain, bloating, nausea, vomiting, or rapid weight gain, which may be signs of ovarian hyperstimulation syndrome (OHSS)
- Get emergency care for chest pain, shortness of breath, or leg pain or swelling, which could signal a blood clot
- Contact your doctor if you develop signs of liver problems such as yellowing of the skin or eyes, dark urine, or severe fatigue
- Tell your doctor immediately if you think you may be pregnant before or during a treatment cycle
Clomiphene warnings and precautions
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- Ovarian Hyperstimulation Syndrome (OHSS): This is the most serious risk. OHSS can develop rapidly and may cause dangerous fluid shifts, blood clots, kidney problems, and in severe cases can be life-threatening. Early signs — abdominal pain and swelling, nausea, vomiting, diarrhea, and rapid weight gain — must be reported to your doctor immediately. Women with PCOS are at higher risk.
- Vision changes: Blurring, spots, flashes, or other visual symptoms can occur and may become permanent with higher doses or longer use. Stop clomiphene and get an eye exam right away if any vision changes appear. Do not drive or use machinery if your vision is affected.
- Multiple pregnancies: Clomiphene increases the chance of conceiving twins or higher-order multiples, which carry higher risks for both mother and babies.
- Ovarian cancer risk: Prolonged use may be associated with a slightly increased risk of borderline or invasive ovarian tumors. Use should not extend beyond the recommended number of cycles.
- Fetal risk: Clomiphene must not be used during pregnancy. Animal studies showed embryo loss and structural abnormalities at high doses.
Clomiphene interactions
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No specific drug interactions with clomiphene have been documented in the FDA label. However, always tell your prescriber and pharmacist about all medications, supplements, and herbal products you take, as your full medical picture matters for safe treatment.
- No formally documented drug-drug interactions are listed in the labeling
Interactions listed in the FDA-approved label
From the Clomiphene prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Clomiphene citrate (drug interactions): Drug interactions with clomiphene citrate have not been documented.
Read the label’s full interactions text
DRUG INTERACTIONS Drug Interactions Drug interactions with clomiphene citrate have not been documented. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of clomiphene citrate. Oral administration of clomiphene citrate to male rats at doses of 0.3 or 1 mg/kg/day caused decreased fertility, while higher doses caused temporary infertility. Oral doses of 0.1 mg/kg/day in female rats temporarily interrupted the normal cyclic vaginal smear pattern and prevented conception. Doses of 0.3 mg/kg/day slightly reduced the number of ovulated ova and corpora lutea, while 3 mg/kg/day inhibited ovulation.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Clomiphene
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- Do not use clomiphene if you are pregnant — it is contraindicated and offers no benefit during pregnancy
- Do not use it if you have current liver disease or a history of liver dysfunction
- Do not use it if you have unexplained abnormal uterine bleeding
- Do not use it if you have ovarian cysts or enlarged ovaries not related to PCOS
- Do not use it if you have uncontrolled thyroid or adrenal dysfunction, or a pituitary tumor
- Use with caution if you have uterine fibroids — clomiphene may cause them to grow larger
- Women with PCOS should start at the lowest recommended dose due to higher sensitivity to the drug's effects
- A pelvic exam is required before starting and before each new treatment course
- Clomiphene is not recommended for treating male infertility; testicular tumors and gynecomastia (breast tissue growth) have been reported in males who used it
- Some active drug may linger in the body into early pregnancy in women who conceive during a treatment cycle — discuss this with your doctor
Clomiphene overdose
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No cases of acute overdose toxicity have been formally reported with clomiphene. If more than the prescribed amount is taken, possible signs include nausea, vomiting, hot flashes, visual blurring, spots or flashes, and ovarian enlargement with pelvic or abdominal pain. In the event of an overdose, seek medical attention promptly and use appropriate supportive care as directed by healthcare providers.
What Clomiphene does in the body
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Clomiphene stimulates the pituitary gland to release more FSH and LH — the hormones that drive follicle growth and egg release in the ovaries. This leads to the development of an ovarian follicle, a rise in estradiol (estrogen), and ultimately ovulation. After ovulation, progesterone and estradiol rise and fall in a pattern that mirrors a normal menstrual cycle. Clomiphene does not have progestational, androgenic, or anti-androgenic activity, and does not meaningfully affect thyroid or adrenal hormone pathways at recommended doses.
How your body processes Clomiphene
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Clomiphene is well absorbed when taken by mouth and is eliminated mainly through the feces, with a smaller portion excreted in the urine. It is made up of two components (isomers) — enclomiphene and zuclomiphene — that behave differently in the body. Zuclomiphene stays in the body much longer, with detectable levels persisting for more than a month after a dose; this is likely due to recycling through the liver and gut. Because of this long persistence, some active drug may still be present in the body during early pregnancy if conception occurs during a treatment cycle.
How to store Clomiphene
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Store tablets at controlled room temperature 15° to 30°C (59° to 86°F). Protect from heat, light, and excessive humidity, and store in closed containers.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Clomiphene
17 supplements and herbal products have documented interactions with Clomiphene in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Clomiphene: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Clomiphene — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does clomiphene do, and how does it help me get pregnant?
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What side effects should I expect, and which ones should make me call my doctor?
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Is there a chance I could have twins or more?
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How long will I be on clomiphene, and what happens if it doesn't work?
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Can I take clomiphene if I'm already pregnant or think I might be?
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Are there any medications or health conditions that mean clomiphene isn't safe for me?
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Is Clomiphene available over the counter?
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When was Clomiphene first available?
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Who makes Clomiphene?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Clomiphene on HelloPharmacist
Clomiphene forms and strengths (how it comes)
Clomiphene is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Clomid, Clomiphene citrate, and MiloPhene tablets are used to treat ovulatory dysfunction in women who want to become pregnant
- Clomid, Clomiphene citrate, and MiloPhene are indicated for conditions such as polycystic ovary syndrome (PCOS), amenorrhea-galactorrhea syndrome, and post-oral-contraceptive amenorrhea where ovulation is absent or irregular
- Clomid, Clomiphene citrate, and MiloPhene tablets are taken by mouth once daily for 5 days per treatment cycle
- Clomid, Clomiphene citrate, and MiloPhene: your prescriber will tell you when in your cycle to start; ovulation typically follows 5 to 10 days after finishing a course
- Clomid, Clomiphene citrate, and MiloPhene: a pelvic exam is required before each treatment cycle, and pregnancy must be ruled out before starting a new course
- Clomid, Clomiphene citrate, and MiloPhene: long-term use is not recommended beyond a total of about six cycles
Clomiphene on the U.S. market: products, makers and brands
How Clomiphene appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
11 companies list 11 Clomiphene product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1967. Brand names on the directory include Clomid, Serophene, MiloPhene; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (30) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Clomiphene is used (Medicaid data)
A general measure of how commonly Clomiphene is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Clomiphene is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Clomiphene prescribed? Of the 1,601 medications we measure, Clomiphene ranks #1,072 by Medicaid prescriptions — more than 33% of them.
Utilization by Clomiphene product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
clomiphene citrate 50 MG Oral Tablet
Summed across the 5 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1093060
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Clomiphene, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 43 listed Clomiphene NDCs with Medicaid activity.
Compare Clomiphene products
A representative set of FDA-listed product records for Clomiphene — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 50 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 50 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 50 mg | Oral | Acetris Pharma Holdings, LLC | ANDA | View NDC → |
| 50 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 50 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Appco Pharma LLC | ANDA | View NDC → |
| 50 mg | Oral | Burel Pharmaceuticals, LLC | ANDA | View NDC → |
| 50 mg | Oral | Camber Pharmaceuticals Inc | ANDA | View NDC → |
| 50 mg | Oral | Cosette Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Cosette Pharmaceuticals NC Laboratories, LLC | ANDA | View NDC → |
| 50 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Clomiphene NDCs →
Clomiphene side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Clomiphene — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Clomiphene in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Clomiphene FDA approval history
How Clomiphene went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Clomiphene recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Clomiphene recalls since July 2021.
✅No Clomiphene recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2596 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 371571In current FDA listingsClinical drug / strength (SCD) citrate 50 MGRxCUI 1093060
Look up RxCUI 2596 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Clomiphene supply and shortage status
Whether Clomiphene is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Clomiphene costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 50 mg | $16.74 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Clomiphene brand names
Clomiphene is sold under 3 brand names in the FDA directory — Clomid, Serophene, MiloPhene. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Clomiphene: manufacturers and labelers
11 companies list Clomiphene products with the FDA. By number of product records, the largest are A-S Medication Solutions, ANI Pharmaceuticals, Inc., Accord Healthcare Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Clomiphene drug class (RxNorm)
Clomiphene belongs to the Estrogen Agonist/Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Clomiphene page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Burel Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →