Chorionic gonadotropin (hCG) is unusual on this site: it has a current FDA label, so its side effects are on paper rather than pieced together from forums. The paper is thinner than the word "label" suggests. The urine-derived product's label lists its adverse reactions in one sentence with no frequencies, and the only measured rates come from fertility trials of the recombinant form. Men using hCG alongside or instead of testosterone — the use most searchers have in mind — sit outside every trial table on either label. This page sets out what the labels say, what FDA's adverse-event reports add, and what is missing. It reports and does not advise; decisions about hCG belong with the prescriber. Labelled dose regimens, in USP Units, are on our hCG dosage page. How brands appear on this site is on our disclosure page.
Two labels, two kinds of evidence
There are two forms of hCG with US labels, and they document side effects very differently.
Urinary hCG (the Novarel/Pregnyl type; the current generic label is Fresenius Kabi's, DailyMed, effective 2025-04-11, BLA 017067). Its entire adverse reactions section reads: "Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection." Nine terms, no percentages, no comparison with placebo. It is an old label written before trial tables were standard, and it has never been rewritten into the modern format.
Recombinant hCG (Ovidrel, EMD Serono, DailyMed, effective 2023-12-26). This label carries measured rates from four studies of 752 patients, 335 of whom received Ovidrel 250 µg — all of them women in fertility treatment.
| Ovidrel 250 µg, per its label | Assisted reproduction (n=236) | Ovulation induction (n=99) |
|---|---|---|
| At least one adverse event | 33.1% | 26.2% |
| Application-site disorders | 14.0% | 16.2% |
| Injection-site pain | 7.6% | 8.1% |
| Injection-site bruising | 4.7% | 3.0% |
| Abdominal pain | 4.2% | 3.0% |
| Nausea | 3.4% | — |
| Vomiting | 2.5% | — |
| Ovarian cyst | — | 3.0% |
| Ovarian hyperstimulation | — | 3.0% |
The same label contains the one head-to-head figure in the US record: across the four studies, injection-site problems occurred in 14.6% (49 of 335) on recombinant hCG against 28% (92 of 328) on an approved urinary hCG — roughly half the rate. That comparison was made in women injecting a single trigger dose, not in anyone injecting several times a week for months.
The serious risks the label names
The urinary label's warnings concern fertility use, where hCG follows menotropins to trigger ovulation. It names four "principal serious adverse reactions": ovarian hyperstimulation (sudden ovarian enlargement, fluid in the abdomen, sometimes around the lungs), rupture of ovarian cysts with internal bleeding, multiple births, and arterial thromboembolism. It adds that anaphylaxis and other allergic reactions have been reported with urine-derived hCG. The precautions section states that multiple ovulation led to plural pregnancies, mostly twins, in about 20% of pregnancies conceived after hCG therapy.
For male and paediatric use, the label's cautions are different: hCG can bring on precocious puberty in boys treated for undescended testes, and because the androgens it stimulates "may cause fluid retention", it is to be used with caution in people with heart or kidney disease, epilepsy, migraine or asthma. It is contraindicated in prostate cancer or other androgen-dependent tumours.
What FDA's adverse-event reports add
We queried FAERS through openFDA on 2026-09-26 for the generic name "chorionic gonadotropin" (dataset updated 2026-07-30). This catches reports FDA has matched to that name; reports naming only a brand, or the recombinant "choriogonadotropin alfa", fall outside it, so the counts are a floor.
- 548 reports in total: 417 in women, 96 in men, the rest unrecorded.
- Most frequent coded reactions overall: ovarian hyperstimulation syndrome 129, drug exposure during pregnancy 37, drug ineffective 37, off-label use 33, ascites 31, ectopic pregnancy 31 — a fertility-clinic profile.
- Among the 96 men: off-label use 7, fatigue 5, then asthenia, nausea, "inappropriate schedule of product administration" and death at 4 each, then deep vein thrombosis, bradycardia, reduced libido and headache at 3 each.
- Co-reported drugs in men: testosterone cypionate 11, testosterone 8, anastrozole 6.
The reading we would put on the male figures is narrow. The top term is not a symptom but a description of how hCG reached the person; the co-reported drugs describe a testosterone-therapy setting in which any effect could come from several products; and four deaths among 96 reports tell us nothing about cause without the case narratives, which openFDA does not publish. What the numbers do show is that the adult-male use common in men's clinics produces reports, and that the labels' trial data do not cover it.
The gap: adult men
Neither label reports a trial of adult men using hCG alongside testosterone, and the search terms that bring people to this page — hCG on testosterone, hCG gynecomastia, hCG water retention — are exactly the use the tables do not cover. The published human data we found for that setting is small. A 2022 retrospective study of 28 men switched from testosterone to hCG alone at a Miami urology practice (Rainer et al., Cureus) reported no significant change in mean hormone levels, HbA1c or PSA, a small fall in haematocrit (45.3% to 44.2%, n=15) and no thromboembolic events. It was retrospective, uncontrolled, followed people for as little as a month and did not report gynecomastia or fluid retention; its authors declared financial relationships. It is a signal about blood count in 15 men, not a safety profile.
The 2020 change that moved the market
Until March 2020, pharmacies could compound hCG. On 2020-03-23 hCG, with other protein products approved as drugs, became a licensed biological product, and FDA's notice to compounders states that from that date these products "will not be eligible for the exemptions for compounded drugs under sections 503A and 503B". The notice names human chorionic gonadotropin among the four bulk substances outsourcing facilities had reported using. Since then, the lawful US sources are the approved products, and hCG sold online as a research chemical — vendors list 2,000 to 10,000 IU vials — is outside both the approved and the compounded channel, with none of the sterility, potency or identity checks either requires. The FAERS report in our TB-500 side-effects record is one example: hCG coded as the suspect product, alongside a blended peptide vial and a note that it was "dispensed by unauthorised provider". Our guide to where peptides come from covers how those channels differ.
The weight-loss question
The urinary label answers it inside its own indications section, in capitals: hCG "has not been demonstrated to be effective adjunctive therapy in the treatment of obesity", with no substantial evidence that it increases weight loss beyond calorie restriction, redistributes fat or reduces hunger. FDA's consumer guidance puts it more bluntly: any loss "is from severe calorie restriction. Not from the HCG." Most "hCG" products sold for dieting are not the injection at all — 13 of the 16 US label records for the molecule are homeopathic drops and sprays, as the census on our dosage page shows — so a side effect reported on such a diet says more about the diet than about hCG.
What the record does not contain
- No incidence figures for any side effect in adult men.
- No trial of hCG combined with testosterone, at any dose or duration.
- No frequency for gynecomastia, fluid retention or mood effects under either label.
- No data on the quality or contents of hCG sold outside pharmacies.
Anyone deciding whether to use hCG, or wondering whether a symptom is connected to it, should take the question to the prescribing clinician; the label is the document to bring. Where it sits among other peptide side-effect records is set out on our peptide side-effects overview.
Sources and dates
- Chorionic Gonadotropin for Injection, Fresenius Kabi USA, BLA 017067. DailyMed setid f93b2baa-03ac-4650-b35a-20b818d712d6, effective 2025-04-11. Read 2026-09-26.
- Ovidrel (choriogonadotropin alfa), EMD Serono. DailyMed setid a683e58a-63ea-44b8-a326-1a99a537bcf2, effective 2023-12-26. Read 2026-09-26.
- FDA. Notice to Compounders: Changes that affect compounding as of March 23, 2020 (content current 2020-03-05). Read 2026-09-26.
- openFDA drug adverse event endpoint, generic name "chorionic gonadotropin", counts by sex, reaction and co-reported drug, run 2026-09-26 (dataset updated 2026-07-30).
- Rainer Q, Pai R, Zucker I, Ramasamy R, Masterson TA. The Safety of Human Chorionic Gonadotropin Monotherapy Among Men With Previous Exogenous Testosterone Use. Cureus. 2022;14(6):e25826. PMID 35822152.