HCG (Pregnyl, Novarel)
HCG is a pregnancy hormone. Shots like Pregnyl and Novarel are legal in the US with a prescription, for some fertility and hormone problems. HCG is NOT approved for weight loss.
The FDA approved it as a prescription medicine for certain uses.
FDA approved for those uses. For weight loss, a trial showed no benefit.
Long use. Side effects are on the FDA label.
These are 3 different questions. FDA status is about the law. Proof is about whether it works. Safety data is about how much we know about its risks. A lack of safety data does not mean it does not work, and "not approved" does not mean "illegal."
By the Peptide Science Desk Editorial TeamFact-checked against FDA and official sources · Not yet reviewed by a licensed clinician. How we check facts
What is it?
HCG is a hormone made during pregnancy. Its full name is human chorionic gonadotropin. It is much bigger than most peptides, but people often group it with them. Shots are sold as Pregnyl, Novarel, and others. You need a prescription.
Why do people use it?
Doctors use HCG shots to help some women release an egg, to treat some men whose low sex hormones come from a brain gland problem, and for some young boys whose testicles have not dropped. Some people use it for an "HCG diet." That use is not approved.
Does it really work?
It is proven and FDA-approved for those medical uses. But the label says plainly that HCG has not been shown to help with weight loss. The FDA says any weight lost on the "HCG diet" comes from eating very little, not from HCG.
Studies in people
| Study | People | What they found | Limits |
|---|---|---|---|
| Randomized trial (weight loss) | 51 women | HCG shots did not add weight loss on top of a 500-calorie diet. | Old study, 32 days. Not an approved use. |
Is it safe? Side effects
- The label lists headache, feeling grumpy or restless, feeling down, feeling tired, swelling, and pain or bruising where the shot goes in.
- In women getting fertility treatment, it can over-stimulate the ovaries (called OHSS). This can become serious.
- The FDA warns that "HCG diet" drops, pellets, and sprays sold without a prescription are illegal. Very low-calorie diets can cause gallstones and an uneven heartbeat.
- HCG is banned in sports for men.
Is it legal in the US?
Yes. HCG shots like Pregnyl and Novarel are FDA-approved, with a prescription, for certain medical uses.
- No HCG product is FDA-approved for weight loss.
- The FDA says HCG sold without a prescription, like "homeopathic" diet drops, is illegal.
- HCG is not a federal controlled drug, but some states, like New York, have stricter rules.
What "not approved" does and does not mean
- With a prescription, it is legal to use for the uses on its FDA label.
- Doctors may also prescribe an approved drug for other uses ("off-label") when they think it is right for you. (FDA)
- Copies made by a pharmacy (compounded) are not FDA approved. The FDA does not check them before they are sold. State boards of pharmacy oversee most pharmacies. (FDA)
- Products sold online "for research" or "not for human use" are not the approved medicine. The FDA has warned companies that sold them to people. (FDA)
Banned in sports? Drug tests
Banned for male athletes.
Yes, for men. WADA bans HCG (chorionic gonadotrophin) at all times for male athletes (section S2.2.1: peptides that raise testosterone in males). Women athletes should still check with USADA.
Is HCG legal in the US? The details
Who can get HCG legally?
- HCG is legal in the US with a prescription from a licensed prescriber.
- The FDA says approved HCG products come only as shots, and only with a prescription.
- The labels cover some cases of female infertility, some men with low sex hormones caused by a brain gland (pituitary) problem, and some young boys whose testicles have not dropped.
Is Pregnyl 5000 legal?
- Yes, with a prescription. The strength does not change the rule.
- The US Pregnyl label lists one size: a 10,000-unit vial. A "Pregnyl 5000" box may be a version made for another country.
- The US Novarel label lists 5,000 and 10,000-unit vials.
- The FDA approved the US versions. Versions made for other countries were not approved by the FDA for US sale. The FDA’s BeSafeRx page explains how to spot a safe online pharmacy.
Is HCG a controlled substance?
- Not under federal law. HCG is not on the DEA’s list of controlled drugs (checked October 22, 2026).
- Some states are stricter. New York rules still treat chorionic gonadotropin (HCG) as a controlled drug, with extra prescription limits.
- California used to list HCG as a controlled drug. A 2025 state law (AB 1152) took it off that list.
- Rules can change. Ask your pharmacist or your state pharmacy board.
Are HCG diet drops legal?
- No. The FDA says all "homeopathic" HCG drops, pellets and sprays sold over the counter for weight loss are sold illegally.
- The FDA and the FTC sent warning letters to 7 companies that sold them.
- The FDA tells people using them to stop and throw them away.
Is HCG approved for weight loss?
- No. The Pregnyl label says, in capital letters, that HCG has not been shown to help treat obesity.
- The FDA has received reports of serious harm in people who used HCG shots for weight loss. They include blood clots in the lungs, depression, problems with blood vessels in the brain, the heart stopping (cardiac arrest) and death. Reports alone do not prove HCG caused each one.
- Very low-calorie diets used with HCG can cause gallstones and an uneven heartbeat, the FDA says.
HCG products: legal status, proof and safety
| Legal status | Proof it works in people | Safety data | |
|---|---|---|---|
| HCG shots (Pregnyl, Novarel) with a prescription | Legal; FDA approved for some fertility and hormone uses | Strong for approved uses | Well studied; risks on the FDA label |
| HCG shots used for weight loss | Not an approved use | Tested: no clear benefit | FDA got reports of serious harm |
| "Homeopathic" HCG drops, pellets, sprays | Sold illegally, says the FDA | Not reviewed by the FDA | Not checked by the FDA |
Talk to your doctor
Do not start any peptide on your own. Ask a doctor first. We never share doses or tell you where to buy. Print our doctor questions sheet.
More questions
Does HCG help weight loss?
No. A trial found HCG did not add weight loss on top of a very low-calorie diet, and the FDA says HCG is not approved for weight loss.
Is HCG a steroid?
No. HCG is a natural hormone made of protein and sugar parts.
Is Pregnyl 5000 legal in the US?
Yes, with a prescription. The US Pregnyl label lists a 10,000-unit vial. The US Novarel label lists 5,000 and 10,000-unit vials. A pharmacy may sell any HCG shot only with a prescription.
Is HCG a controlled substance?
Not under federal law. It is not on the DEA list. New York still treats it as a controlled drug. California took it off its list in a 2025 law.
Does HCG raise testosterone?
HCG is approved to treat some men whose low sex hormones come from a brain gland problem. Ask a doctor.
Is HCG a peptide?
The Pregnyl label calls it a "polypeptide hormone" with 2 parts (alpha and beta). It is much bigger than most peptides, but people often group it with them.
Is HCG the same as testosterone?
No. The Pregnyl label says HCG tells cells in the testicles to make male hormones. HCG itself is not testosterone and not a steroid.
Where can I report a bad HCG product?
You can report it to the FDA through MedWatch.
Can I fly with HCG?
Our TSA guide covers flying with prescription peptides and shots.
Related peptides
- GonadorelinOff market · Proof: None found
- Kisspeptin-10Not approved · Proof: Early
- Trelstar / Triptodur (triptorelin)FDA approved · Proof: Strong
Guides and tools
- Flying with peptides: TSA rules in plain wordsGuide
- Can peptides make you infertile?Guide
- Peptides vs TRT vs SARMs: which is safer?Guide
- Are Peptides Legal in the US?Guide
- Can a doctor prescribe peptides?Guide
- Drug test & sports ban checkerTool
- Compare HCG with another peptideTool
- Is my peptide source legit?Tool
- FDA warning letters trackerTool
Sources
- DailyMed: Pregnyl (chorionic gonadotropin) official drug label
- DailyMed: Novarel (chorionic gonadotropin) official drug label
- FDA: Questions and Answers on HCG Products for Weight Loss
- FDA Consumer Update: Avoid Dangerous HCG Diet Products
- DEA Diversion Control: Controlled substances, alphabetical list (HCG is not listed)
- New York rules (10 NYCRR 80.71): controlled substances, including chorionic gonadotropin
- WADA: 2026 Prohibited List (sports anti-doping rules)
- California AB 1152 (2025): removes human chorionic gonadotropin (hCG) from Schedule III
- FDA: BeSafeRx, how to find a safe online pharmacy
- PubMed: Stein et al., Ineffectiveness of human chorionic gonadotropin in weight reduction: a double-blind study, Am J Clin Nutr 1976
- FDA: MedWatch, report a problem with a medicine