Short answer: The Novarel label lists headache, irritability, restlessness, depression, fatigue, edema (swelling), precocious puberty, gynecomastia (breast growth) and pain at the injection site, without percentages. Allergic reactions such as redness, hives, rash, swelling and shortness of breath have been reported. When used with menotropins for ovulation, the main serious risks are ovarian hyperstimulation, ovarian cyst problems, multiple births and arterial blood clots.
What Novarel is approved for: Novarel (hCG) is approved for prepubertal cryptorchidism (undescended testicles) not caused by a physical blockage, for selected cases of hypogonadotropic hypogonadism in males (low testosterone from a pituitary deficiency), and to induce ovulation and pregnancy in anovulatory, infertile women whose anovulation is not from primary ovarian failure and who have been pretreated with human menotropins. The label states hCG has not been shown to be effective for treating obesity (Indications and Usage).
Source
NOVAREL (chorionic gonadotropin) for injection, for intramuscular use, prescribing information. Ferring Pharmaceuticals. DailyMed, version published September 25, 2025. DailyMed setid ac6918ff-9dc3-40d9-8619-54b26e4bdfc8
No. The current Novarel label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Novarel.
| Type | Reactions the label lists |
|---|---|
| General | Headache, irritability, restlessness, depression, fatigue, edema |
| Hormonal | Precocious puberty, gynecomastia |
| Injection site | Pain at the site of injection |
| Hypersensitivity (localized and systemic) | Erythema, urticaria, rash, angioedema, dyspnea and shortness of breath |
The label lists these reactions without percentages or a placebo comparison, and refers back to the Warnings for the serious reactions seen with ovulation induction.
The label says it is not clear whether the allergic-like reactions come from the hormone itself or from the benzyl alcohol in the diluent.
With menotropins for ovulation induction, the label names four principal serious reactions: (1) ovarian hyperstimulation, (2) enlargement or rupture of existing ovarian cysts with bleeding into the abdomen, (3) multiple births and (4) arterial thromboembolism.
Safety and effectiveness in children below the age of 4 have not been established. For cryptorchidism, the label says therapy is usually started between the ages of 4 and 9.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Specialist use with menotropins. When hCG is used with human menopausal gonadotropins, the label says it should be used only by physicians experienced with infertility who know the menotropins prescribing information.
Ovarian hyperstimulation. A syndrome of sudden ovarian enlargement, fluid in the abdomen (ascites) with or without pain, and/or fluid around the lungs (pleural effusion).
Ovarian cysts. Existing ovarian cysts can enlarge or rupture, causing bleeding into the abdomen (hemoperitoneum).
Multiple births and blood clots. Multiple births and arterial thromboembolism are listed among the principal serious reactions during ovulation induction.
Benzyl alcohol. The preservative benzyl alcohol in the diluent the label recommends has been reported to be associated with a fatal "gasping syndrome" in premature infants.
Anaphylaxis. Anaphylaxis (a severe allergic reaction) has been reported with urine-derived hCG products.
Early puberty in boys treated for cryptorchidism. hCG raises androgen (male hormone) production, which may cause precocious puberty in boys treated for undescended testicles. The label says therapy should be stopped if signs of early puberty appear.
Fluid retention. Because androgens can cause fluid retention, the label says hCG is used with caution in people with heart or kidney disease, epilepsy, migraine or asthma.
Lab test interference. hCG can cross-react in gonadotropin blood tests, especially luteinizing hormone (LH), so the lab should be told when someone is on hCG.
Testicular tumors. There have been sporadic reports of testicular tumors in otherwise healthy young men given hCG for secondary infertility. The label says a causal link has not been established.
Who should not use it. Precocious puberty, prostate cancer or other androgen-dependent tumors, and a prior allergic reaction to hCG. The label also says hCG may cause fetal harm when given to a pregnant woman.
From the Warnings, Precautions and Adverse Reactions (the label has no Medication Guide or patient information) that comes with Novarel:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.