Prescription medicine
Clomiphene Brand names: Clomid, Milophene
Clomiphene (Clomid) is a prescription medicine with an FDA approval on record since 1967. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $4.21 per clomiphene citrate 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the clomiphene FDA label on DailyMed (effective December 1, 2025, Accord Healthcare Inc.); the NDA 16131 record on Drugs@FDA; every clomiphene label on DailyMed.
Highlights of the record
FDA label of December 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageClomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy.
Forms and strengths
- 50 mg
Tablet.
On the market
- Earliest approval on file
- February 1, 1967 Clomid, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first December 20, 1988; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 11 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $4.21 per tablet Clomiphene citrate 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2015 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 1,483 through July 30, 2026
What is clomiphene used for?
From the label: indications and usageClomiphene 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. 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. […]
FDA pharmacologic class: Estrogen Agonist/Antagonist.
Source: FDA drug label (Clomiphene Citrate), Accord Healthcare Inc., effective December 1, 2025 (SPL set 79f64995-7425-44c6-9f44-f7d20daeff65), via openFDA; the full label on DailyMed
Is there a generic for clomiphene (Clomid)?
The FDA approved the first generic clomiphene on December 20, 1988. 7 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clomiphene from 11 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1967 earliest approval on file
- 1988 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clomiphene (Clomid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.21 per Clomiphene citrate 50 mg tablet, down 42% from $7.22 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clomiphene citrate 50 mg tablet (generic)
- Clomid 50 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clomiphene citrate 50 mg tablet | Generic | $4.21 per tablet | $126.16 | -42% |
| Milophene 50 mg tablet | Generic | $4.21 per tablet | $126.16 | -48% |
| Clomid 50 mg tablet | Brand | $16.74 per tablet | $502.30 | +52% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clomiphene been recalled?
The FDA's Enforcement Report lists 2 recalls naming clomiphene since 2015: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| September 10, 2015 | Class III | EMD Serono, Inc. | Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for clomiphene?
The FDA Adverse Event Reporting System holds 1,483 reports that list clomiphene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 52 are coded as a death and 334 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other estrogen agonist/antagonists
- the pharmacologic class, with prices and generics
- Clomiphene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other