hCG: Uses, Dosage and Side Effects of the FDA-Approved Drug
hCG uses, dosage and side effects from the FDA-approved label - not the unapproved homeopathic weight-loss drops sold over the counter.
The short version
Human chorionic gonadotropin (hCG) is an FDA-approved prescription injection (brands include Novarel and Pregnyl) with three uses: undescended testes in boys (prepubertal cryptorchidism), selected cases of male hypogonadotropic hypogonadism, and inducing ovulation in infertile women after menotropin pretreatment. It is not approved for weight loss. FDA and FTC have jointly warned that over-the-counter "homeopathic" hCG drops, pellets and sprays sold for weight loss are unapproved drugs with unsubstantiated claims.
- Three FDA-approved uses, all by prescription injection: cryptorchidism, male hypogonadotropic hypogonadism, and ovulation induction.
- FDA says there is no substantial evidence hCG adds weight loss beyond the very-low-calorie diet paired with it.
- FDA and FTC sent seven joint warning letters to firms selling "homeopathic" OTC hCG for weight loss.
- Serious labeled risks in fertility use include ovarian hyperstimulation, multiple births and arterial thromboembolism.
- hCG has been a licensed biologic since 23 March 2020, and FDA says biologics cannot be compounded under 503A or 503B.
Human Chorionic Gonadotropin at a glance
- What it is
- Glycoprotein hormone (LH receptor agonist)
- Main use
- FDA-approved prescription injection for prepubertal cryptorchidism, selected cases of male hypogonadotropic hypogonadism, and induction of ovulation in anovulatory, infertile women pretreated with menotropins.
- Generic name
- chorionic gonadotropin
- Brand names
- Novarel (Ferring Pharmaceuticals) and Pregnyl (Organon) Label
- Also called
- hCG
- Size
- 237 amino acids Details
- Evidence
- Strong human evidence
- US status
- FDA-approved · prescription only
- Half-life
- Approximately 24-36 hours per published pharmacokinetic literature; the approved label does not itself state a half-life figure.
- Dose
- Set by the FDA label Dosing page
Human chorionic gonadotropin (hCG) is a glycoprotein hormone. Its FDA-approved form is a prescription injection (chorionic gonadotropin, sold as Novarel). The same name is printed on unapproved “homeopathic” drops sold over the counter for weight loss. This page covers the approved drug first, then the OTC products. Dosing: the exact schedules from the label.
US legal status - FDA-approved · prescription only
Chorionic gonadotropin injection (e.g. Novarel) is FDA-approved by prescription for cryptorchidism, selected male hypogonadotropic hypogonadism, and ovulation induction. It requires a prescriber. It has been a licensed biologic since 23 March 2020, so FDA says it cannot be compounded under 503A or 503B. Over-the-counter "homeopathic" hCG products are unapproved new drugs per FDA and FTC.
What is hCG approved for?
| Use | Population | What it does |
|---|---|---|
| Prepubertal cryptorchidism | Boys, not due to anatomic obstruction | May help predict whether orchiopexy will later be needed |
| Hypogonadotropic hypogonadism | Selected cases in males | Stimulates testicular testosterone production |
| Ovulation induction | Anovulatory, infertile women with secondary anovulation, after menotropin pretreatment | Triggers final follicle maturation and ovulation |
The label is explicit about what it is not approved for: “HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity.” No dose is approved for weight loss, muscle building or testosterone-therapy support.
Human Chorionic Gonadotropin structure
- Length
- 237 amino acids
- Modifications
- Two glycosylated protein chains held together non-covalently: an alpha subunit of 92 residues (shared with LH, FSH and TSH; UniProt P01215) and an hCG-specific beta subunit of 145 residues (UniProt P0DN86).
A large glycoprotein hormone with no PubChem compound record. Urinary hCG products carry variable sugar chains, so no single exact formula exists. The UniProt entries describe the natural protein, which is what these products are.
Sequence checked against FDA prescribing information (Pregnyl), DailyMed.
How it works
hCG is similar in structure to luteinizing hormone (LH) and binds the same LH receptor.
- In males, it stimulates the testes’ Leydig cells to make testosterone.
- In females, a single dose after menotropin pretreatment triggers the final maturation and release of the egg.
Neither involves fat metabolism, which is why the label carries the obesity disclaimer above.
hCG dosage
The FDA label gives a separate schedule for each approved use, all injected into muscle:
- Prepubertal cryptorchidism: four alternative regimens, each a short course over three to six weeks.
- Male hypogonadotropic hypogonadism: 500-1,000 USP Units three times a week with a taper, or a longer 4,000 USP Unit regimen over six to nine months.
- Ovulation induction: usually a single 5,000-10,000 USP Unit dose, one day after the last menotropin dose.
There is no approved weight-loss dose, because there is no approved weight-loss use. Exact regimens, table by table: hCG dosage.
hCG side effects
These come from the current FDA label for chorionic gonadotropin injection (Novarel). The label gives no rates or percentages for any of them.
- Commonly listed: headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, and pain at the injection site.
- Allergic reactions: erythema, urticaria, rash, angioedema, dyspnea and shortness of breath. Anaphylaxis has been reported with hCG products purified from urine.
- Serious risks in ovulation induction: ovarian hyperstimulation syndrome (sudden ovarian enlargement, ascites and/or pleural effusion); enlargement or rupture of an existing ovarian cyst, which can cause bleeding into the abdomen (hemoperitoneum); multiple births; and arterial thromboembolism. The label says hCG should be used with menopausal gonadotropins only by physicians experienced in infertility treatment.
- Contraindicated in: precocious puberty, prostate cancer or other androgen-dependent tumours, a prior allergic reaction to hCG, and pregnancy (hCG may cause fetal harm).
For redness, itching or swelling at the injection site, see injection-site reactions.
Dosing detail from the same label: hCG dosage.
Is hCG legal?
FDA’s conclusion on effectiveness: “There is no substantial evidence that HCG increases weight loss.” Weight lost on these regimens comes from the very-low-calorie diet that goes with them, typically around 500 calories a day, not from the hCG.
FDA warns that the diet itself is risky, causing gallstones, electrolyte imbalance and irregular heartbeat, and should only be followed under proper medical supervision. Its advice to anyone using a homeopathic hCG product: stop using it, stop following its diet instructions, and throw it away.
Telling the products apart is simple. The FDA-approved drug is a prescription injection, dispensed after a diagnosis, for the three uses above. Anything sold without a prescription, as a drop, pellet or spray labeled “homeopathic”, is not that drug.
Is compounded hCG legal?
hCG has been regulated as a biological product since 23 March 2020. On that date, under the Biologics Price Competition and Innovation Act of 2009, the approvals for hCG products were deemed to be biologics licences (BLAs). FDA’s list of those approvals includes Pregnyl, Novarel and Ovidrel.
FDA’s January 2018 guidance says licensed biologics are not eligible for the 503A and 503B compounding exemptions. In its words, the law “does not provide a legal pathway for marketing biological products that have been prepared outside the scope of an approved BLA.” FDA’s March 2020 notice to compounders named human chorionic gonadotropin among the substances affected.
So “compounded hCG” from a clinic or pharmacy has no compounding pathway under FDA’s rules. The 2018 guidance describes one exception. FDA does not intend to act when a state-licensed pharmacy or outsourcing facility mixes, dilutes or repackages a licensed product, such as a Novarel vial, under set conditions. That policy does not cover hCG made from a bulk drug substance.
Related
- hCG dosage: the approved label schedules
- Peptides and TRT: what has (and has not) been studied
- Gonadorelin
- Are peptides safe?
How it differs from the reproductive signal peptide: Kisspeptin vs HCG.
Regulatory changes for this compound and others, as they happen: US peptide regulation tracker.
How Human Chorionic Gonadotropin compares
Reproductive hormones. Doses for unapproved compounds are common practice, not trial-established. All hormones and sexual health peptides →
| Compound | Main use | Evidence | Usual dose | US status |
|---|---|---|---|---|
| Kisspeptin | Studied in hospital-based human research as a reproductive-hormone signal - it stimulates LH and FSH release upstream of GnRH - and, in a small number of academic trials, for its effect on sexual and romantic brain processing. Sold to consumers for sexual desire and fertility use, a use no regulator has evaluated as safe or effective. | Limited human data | 50-200 mcg, once or twice daily, 50-200 mcg per injection | Research use only |
| Gonadorelin | FDA approved decades ago as a diagnostic test of pituitary function (Factrel) and as a pulsatile treatment for hypothalamic amenorrhea (Lutrepulse). Both approved products are discontinued. Today it is mainly sold through compounding pharmacies and research-peptide sellers to men on testosterone therapy, paired with TRT to keep the pituitary-testicular signal running - a use no trial has tested. | Moderate human evidence | 50-100 mcg, 2-3 times weekly, subcutaneous, spaced through the week (e.g. Monday/Thursday or Monday/Wednesday/Friday), alongside testosterone therapy | Unapproved drug |
| Human Chorionic Gonadotropin | FDA-approved prescription injection for prepubertal cryptorchidism, selected cases of male hypogonadotropic hypogonadism, and induction of ovulation in anovulatory, infertile women pretreated with menotropins. | Strong human evidence | FDA label | FDA-approved · prescription only |
| Human Menopausal Gonadotropin | FDA-approved prescription injection (Menopur) for development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle. Not approved for any indication in men. | Strong human evidence | FDA label | FDA-approved · prescription only |
| Oxytocin | An approved injectable medicine in obstetrics. Sold online as a nasal spray for libido, connection and anxiety. | Moderate human evidence | FDA label | FDA-approved · prescription only |
Where to get Human Chorionic Gonadotropin legally
Human Chorionic Gonadotropin is an FDA-approved prescription medicine, so the legal route is a licensed prescriber, in person or by telehealth, and a licensed pharmacy.
With a prescription, a 10,000-unit vial of generic hCG costs $306 at HealthWarehouse.com (as of 3 October 2026).
Every legal route for hCG, with dated prices →
How telehealth prescribing works, what it costs and what to check: telehealth peptide prescribing.
Research-labelled hCG (not the approved medicine)
These checked vendors sell a research-labelled version. It has not been reviewed by FDA, is labelled not for human use, and is tested only as the seller chooses.
1.Next Level Pharm
2,000 IU vial
- No FDA warning letter found
- Names its testing lab
- Batch COAs published
- Takes card payment
Common questions
What is hCG?
Human chorionic gonadotropin (hCG) is a glycoprotein hormone similar in structure to luteinizing hormone (LH). The FDA-approved prescription form (e.g. Novarel, Pregnyl) is an injection, purified from urine, that acts on the same LH receptor. The name also appears on unapproved over-the-counter 'homeopathic' drops sold for weight loss.
What is the usual hCG dose?
There is no single dose. The label gives a separate injection-into-muscle schedule for each approved use: four regimens for prepubertal cryptorchidism, two for male hypogonadotropic hypogonadism, and a single 5,000-10,000 USP Unit dose for ovulation induction. There is no approved weight-loss dose. Exact regimens: [hCG dosage](/hcg-dosage/).
Is hCG approved for weight loss?
No. The current label says hCG has not been shown to be effective add-on therapy for obesity. FDA has also said there is no substantial evidence that hCG increases weight loss beyond the very-low-calorie diet usually paired with it.
What is "homeopathic" hCG and is it legal?
Unapproved over-the-counter drops, pellets and sprays sold for weight loss under the hCG name. FDA and FTC have jointly sent warning letters to firms selling them, calling them unapproved new drugs, misbranded because of unsubstantiated weight-loss claims. FDA has not evaluated them for safety or effectiveness.
Is Pregnyl still available?
Yes. DailyMed lists an active Pregnyl label (Organon LLC) alongside Novarel; both are FDA-approved chorionic gonadotropin injections purified from urine. If you are prescribed hCG, ask your pharmacist which brand or generic you are getting.
What are the side effects of hCG?
The FDA label, which gives no frequencies, lists headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and injection-site pain, plus allergic reactions such as erythema, urticaria, rash and angioedema. Anaphylaxis has been reported with urine-derived hCG. In fertility use the serious risks are ovarian hyperstimulation syndrome, enlargement or rupture of existing ovarian cysts, multiple births and arterial thromboembolism. It is contraindicated in precocious puberty, prostate or other androgen-dependent cancers, prior allergy to hCG, and pregnancy.
Can I buy hCG without a prescription?
Not the approved drug, which is a prescription-only injection. Any hCG sold over the counter, as drops, pellets, sprays or a 'homeopathic' formula, is not the FDA-approved product and has not been reviewed by FDA for safety or effectiveness.
Is hCG better than TRT?
The label does not compare them, so I don't rank them. It approves hCG only for selected cases of hypogonadotropic hypogonadism in males (low testosterone from a pituitary deficiency), where it makes the testes produce their own testosterone. It is not approved as an add-on to testosterone therapy. Which, if either, fits is a prescriber's call based on diagnosis.
How can I get pregnant with an hCG injection?
Only through a fertility specialist. The label approves hCG to induce ovulation in infertile women whose anovulation is secondary, not primary ovarian failure, after treatment with menotropins. It is given as a single 5,000-10,000 USP Unit dose into muscle one day after the last menotropin dose. The label limits this to doctors experienced in infertility and lists ovarian hyperstimulation and multiple births among the main serious risks.
How long does it take for hCG injections to work?
The label gives no onset time, only course lengths. Cryptorchidism courses last up to six weeks. Male hypogonadism regimens run from six weeks to six to nine months, then may continue at a lower dose for three more months. Ovulation induction is a single dose one day after the last menotropin dose. The prescriber judges whether it is working.
Does hCG make men feel better?
The label makes no claim about mood, energy or wellbeing. Its only approved use in adult men is selected cases of hypogonadotropic hypogonadism, where it stimulates testosterone production. Its listed side effects include headache, irritability, restlessness, depression and fatigue, so feeling worse is also possible. Raise any hoped-for wellbeing effect with your prescriber.
What is the brand name of chorionic gonadotropin?
Chorionic gonadotropin is sold under the brand names Novarel and Pregnyl. Novarel is approved for prepubertal cryptorchidism (undescended testes) not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in anovulatory infertile women pretreated with menotropins. Pregnyl is approved for prepubertal cryptorchidism (undescended testes) not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in anovulatory infertile women pretreated with gonadotropins.
What is the generic name for Novarel?
The generic name for Novarel is chorionic gonadotropin. Novarel is Ferring Pharmaceuticals's brand, approved for prepubertal cryptorchidism (undescended testes) not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in anovulatory infertile women pretreated with menotropins.
What is the generic name for Pregnyl?
The generic name for Pregnyl is chorionic gonadotropin. Pregnyl is Organon's brand, approved for prepubertal cryptorchidism (undescended testes) not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in anovulatory infertile women pretreated with gonadotropins.
Is Novarel the same as chorionic gonadotropin?
Yes. Novarel is a brand of chorionic gonadotropin, made by Ferring Pharmaceuticals: the active ingredient is chorionic gonadotropin. It comes as a intramuscular injection (5,000 or 10,000 USP unit multiple-dose vial, reconstituted), dosed at varies by indication, e.g. 5,000 to 10,000 USP units once, one day after the last menotropins dose, to induce ovulation. Compounded or research-vial chorionic gonadotropin is not Novarel and has not been through its FDA review.
Is Pregnyl the same as chorionic gonadotropin?
Yes. Pregnyl is a brand of chorionic gonadotropin, made by Organon: the active ingredient is chorionic gonadotropin. It comes as a intramuscular injection (10,000 USP unit multiple-dose vial, reconstituted), dosed at varies by indication, e.g. 5,000 to 10,000 USP units once, one day after the last gonadotropin dose, to induce ovulation. Compounded or research-vial chorionic gonadotropin is not Pregnyl and has not been through its FDA review.
Is Novarel the same as Pregnyl?
Novarel and Pregnyl contain the same active ingredient, chorionic gonadotropin. They are approved for different uses and doses: Novarel for prepubertal cryptorchidism (undescended testes) not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in anovulatory infertile women pretreated with menotropins (varies by indication, e.g. 5,000 to 10,000 USP units once, one day after the last menotropins dose, to induce ovulation); Pregnyl for prepubertal cryptorchidism (undescended testes) not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in anovulatory infertile women pretreated with gonadotropins (varies by indication, e.g. 5,000 to 10,000 USP units once, one day after the last gonadotropin dose, to induce ovulation).
What well-known people have said about Human Chorionic Gonadotropin
Public statements, shown because people search for them. Each is one person's account, in their words or a faithful summary, with where and when they said it. None of it is evidence that Human Chorionic Gonadotropin works or is safe; that is what the rest of this page is for.
Dr. Mehmet OzTV physicianDiscussed it
Oz said on TODAY in February 2013 that the hCG diet was still an experiment that deserved study and should only be done with a reputable doctor. He did not say he had used it.
“It's still an experiment but this is not some crazy wacky idea.”
TODAY (NBC) interview, 6 February 2013. Source: TODAY
Photo: United States Centers for Medicare and Medicaid, Public domain, via Wikimedia Commons
References (7 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.NOVAREL (chorionic gonadotropin) for injection - full prescribing information: indications, dosage and administration, contraindications, warnings and adverse reactions.- DailyMed, National Library of Medicinelabel
- 2.FDA's Questions and Answers on HCG Products for Weight Loss - seven joint FDA/FTC warning letters against homeopathic hCG marketers, product forms, and FDA's statement on lack of weight-loss evidence.- US Food and Drug Administrationregulatory
- 3.FDA consumer update, Avoid Dangerous HCG Diet Products - risks of the very-low-calorie diet paired with HCG weight-loss products, including gallstones, electrolyte imbalance and irregular heartbeat.- US Food and Drug Administrationregulatory
- 4.FDA's List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 - includes chorionic gonadotropin (Pregnyl, Novarel, Fresenius Kabi and others) and Ovidrel.- US Food and Drug Administrationregulatory
- 5.FDA Notice to Compounders: Changes that affect compounding as of March 23, 2020 - transitioning biologics lose the 503A and 503B exemptions; names human chorionic gonadotropin among the affected substances.- US Food and Drug Administrationregulatory
- 6.FDA guidance, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved BLA (January 2018) - licensed biologics are not eligible for the 503A and 503B compounding exemptions.- US Food and Drug Administrationregulatory
- 7.PREGNYL (chorionic gonadotropin) for injection - prescribing information- DailyMed, National Library of Medicinelabel