Prescription only
Clomiphene Citrate
Sold as Clomid, Milophene, Serophene.
What the label states
THIS IS A DOSE FOR WOMEN. “Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days.” If ovulation does not follow, “a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given”, and “increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended.” The indication those doses belong to is “the treatment of ovulatory dysfunction in women desiring pregnancy”. The label states no dose for men.
Quoted from the approved product label. Clinics commonly prescribe differently — more frequent, smaller injections of the same weekly total are routine — and where this site describes that, it is named as practice rather than as labelling.
- Route
- Oral, once daily for five days per cycle
- Vehicle
- None — a 50 mg uncoated oral tablet. The tablet contains a mixture of two isomers, zuclomiphene and enclomiphene, at a ratio the label states rather than fixes precisely.
- Usual barrel
- None — this compound is not drawn into a syringe
- Strengths covered
- No strength page yet
Why there is no syringe
There is no syringe — clomiphene is a 50 mg oral tablet — and the field is worth using to flag the conversion that actually goes wrong on this drug, which is not a volume but an indication. Every dose on the label is a five-day course timed to a menstrual cycle in a woman being treated for anovulation. Men are prescribed it continuously or on alternate days at doses derived from case series, none of which appears on any label. Reading the labelled 50 mg figure across to a man is reading a number out of a schedule it does not belong to, and this page prints the female schedule with its indication attached for exactly that reason.
Administration
- 1
Read the indication before the dose
“Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy.” The label lists the patients it applies to — polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea and certain cases of secondary amenorrhea of undetermined etiology — and every one of them is a woman being treated to achieve a pregnancy. There is no male indication on any clomiphene label in the United States.
- 2
Note what the label says about men specifically
It is not silent. The INDICATIONS AND USAGE section states: “There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate 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 is not known.” That paragraph sits inside the approved label and is the closest thing to labelled male guidance that exists.
- 3
Understand what is in the tablet
“Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer.” The proportion is a range, not a fixed figure, and the label adds that “some data suggest that zuclomiphene has greater estrogenic activity than enclomiphene.” Zuclomiphene is also the longer-lived of the two, which is the basis of the argument for using the isolated trans-isomer instead — an argument that has not produced an approved product.
- 4
Report visual symptoms immediately
The label carries a dedicated Visual Symptoms warning in its WARNINGS section. Blurring, spots or flashes are a recognised class effect, and they are a reason to contact a prescriber rather than to wait and see.
- 5
Take the liver contraindication seriously
“Clomiphene citrate therapy is contraindicated in patients with liver disease or a history of liver dysfunction.” The label’s patient-selection list also requires normal liver function before the first course. This is one of the few contraindications that transfers cleanly from the labelled population to an off-label male one.
Storage
- —“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” — quoted from the HOW SUPPLIED section of the CLOMID label.
- —Supplied as 50 mg round, off-white, debossed tablets in cartons of 10 and 30.
- —Keep out of reach of children, and out of reach of anyone who could become pregnant without intending to — this is an ovulation-inducing drug and is contraindicated in pregnancy.
Monitoring
| Marker | When | Why |
|---|---|---|
| Liver function | Before starting | Liver disease or a history of liver dysfunction is an absolute contraindication on the label, and the patient-selection criteria require normal liver function before the first course. |
| Visual symptoms | Any time — report immediately | A dedicated warning in the label’s WARNINGS section. Symptoms are generally reversible on stopping, but they are a reason to stop and be assessed rather than to continue. |
| Total testosterone, LH and FSH, if used off-label in a man | As your prescriber specifies — no labelled schedule exists for male use | There is no labelled male monitoring because there is no labelled male use. The AUA guideline notes only that patients on anastrozole, clomiphene citrate or hCG “should be tested no earlier than four weeks” after starting, which is a timing point rather than a protocol. |
| Gynecomastia and testicular findings | Symptom-driven, if used off-label in a man | Because the label names both: “testicular tumors and gynecomastia have been reported in males using clomiphene”, while stating that causality for the tumour reports is not established. Naming what the label names is more useful than an incidence figure it does not give. |
Frequently asked questions
- Is clomiphene FDA-approved for men?
- No. CLOMID and every generic clomiphene citrate tablet are approved for “the treatment of ovulatory dysfunction in women desiring pregnancy”. There is no male indication on any US clomiphene label. Prescribing it to a man for low testosterone or male infertility is off-label — legal for a physician, and not a use the FDA has evaluated. The label itself addresses the point: “There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate in the treatment of male infertility.”
- What dose does the label state?
- Fifty milligrams daily for five days, as the first course of an ovulation-induction cycle in a woman: “Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days.” A second course of 100 mg daily for five days may follow if ovulation does not occur, and “increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended.” The label also caps total treatment at “about six cycles”. None of that schedule was designed for, tested in, or written about men, and this page does not translate it.
- What do the guidelines say about clomiphene in men?
- Two major guidelines address it and they differ in tone. The Endocrine Society's 2018 testosterone guideline carries a single technical remark under recommendation 2.1: “Clomiphene citrate has been used empirically in men with hypogonadotropic hypogonadism; however, neither its efficacy nor its safety has been demonstrated in randomized trials.” The AUA's guideline statement 27 is more permissive: “Clinicians may use aromatase inhibitors, human chorionic gonadotropin, selective estrogen receptor modulators, or a combination thereof in men with testosterone deficiency desiring to maintain fertility. (Conditional Recommendation; Evidence Level: Grade C)” — but its discussion adds the line that frames the whole class: “Clinicians should understand that of these agents, only hCG has been approved by the FDA for use in males.” Clomiphene is one of the agents that sentence excludes.
- Is clomiphene the same as enclomiphene?
- Not quite — enclomiphene is one of the two isomers that make up clomiphene. The label states: “Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer,” and adds that “some data suggest that zuclomiphene has greater estrogenic activity than enclomiphene.” The regulatory difference is larger than the chemical one: clomiphene is approved, for women; enclomiphene has never been approved for anything.
- Does this page tell me whether clomiphene will raise my testosterone?
- No, because no labelled answer exists and this page does not substitute a forum consensus for one. What can be stated is what the two guidelines say — that its efficacy and safety in men have not been demonstrated in randomised trials (Endocrine Society), and that it may be used in men wanting to preserve fertility as a conditional, Grade C recommendation while remaining unapproved for male use (AUA). Whether it is right for you, at what dose and for how long, is a prescriber’s judgement made off-label and should be identified as such at the point it is offered.
Sources
- [1]FDA label — CLOMID (clomiphene citrate) Tablets, USP, Cosette Pharmaceuticals, Inc. (DailyMed SPL 2ca373c1-4dba-4126-8616-5c533d606fe5; marketing category ANDA 075528 — the originator NDA 016131 held by Sanofi Aventis is listed in Drugs@FDA as discontinued). Source of the ovulatory-dysfunction indication, the 50 mg × 5 days dosing, the male-infertility paragraph, the isomer description, the liver contraindication and the storage statement
- [2]Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715–1744 (PMID 29562364). Source of the clomiphene technical remark under recommendation 2.1. Read in full on 2026-09-19: the guideline contains no mention of aromatase inhibitors, anastrozole or letrozole
- [3]Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018;200(2):423–432 (PMID 29601923). Statement 27 and its discussion — the source of both quoted sentences, including “Clinicians should understand that of these agents, only hCG has been approved by the FDA for use in males.”
- [4]Drugs@FDA: FDA-Approved Drugs — used to confirm that every approved clomiphene citrate application carries an ovulation-induction indication in women and that none carries a male indication
Related
Educational reference, not medical advice. Dose, route and whether this compound is appropriate at all are decisions for your clinician.