Short answer: In the label's 12-week placebo-controlled trial in HIV wasting, the most common Serostim side effects on 0.1 mg/kg daily were joint pain (36.4% vs 11.3% on placebo), muscle pain (30.4% vs 11.7%), peripheral swelling (26.1% vs 2.8%) and arthrosis (10.7% vs 3.6%). They were less frequent on every-other-day dosing and often eased with time or a lower dose. Serostim has no boxed warning.
What Serostim is approved for: Serostim is approved for adults with HIV and wasting or cachexia, to increase lean body mass and body weight and improve physical endurance. The label says antiretroviral therapy must be taken at the same time (section 1). It is not approved for growth hormone deficiency or for HIV lipodystrophy.
Source
SEROSTIM (somatropin) for injection, for subcutaneous use, prescribing information. EMD Serono. DailyMed, version published September 25, 2026. DailyMed setid 62b01d29-90f0-45b2-a0c4-3a750ba36c8a
No. The current Serostim 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 Serostim.
| Adverse reaction | Placebo (n=247) % | Serostim 0.1 mg/kg every other day (n=257) % | Serostim 0.1 mg/kg daily (n=253) % |
|---|---|---|---|
| Arthralgia | 11.3 | 24.5 | 36.4 |
| Myalgia | 11.7 | 17.9 | 30.4 |
| Arthrosis | 3.6 | 7.8 | 10.7 |
| Nausea | 4.9 | 5.4 | 9.1 |
| Edema Peripheral | 2.8 | 11.3 | 26.1 |
| Fatigue | 4.5 | 3.5 | 5.1 |
| Gynecomastia | 0.4 | 3.5 | 5.5 |
| Paresthesia | 4.5 | 7.4 | 7.9 |
| Hypoesthesia | 2.4 | 1.6 | 5.1 |
| Edema Generalized | 1.2 | 1.2 | 5.9 |
Adults with HIV-associated wasting or cachexia, first 12 weeks, all on antiretroviral therapy. Listed without regard to causality. About 23% on 0.1 mg/kg daily and 11% on 0.1 mg/kg every other day needed a dose reduction; 10.3% and 6.6% stopped because of side effects.
| Adverse reaction | Placebo (n=159) % | Serostim 4 mg every other day (n=80) % | Serostim 4 mg daily (n=326) % |
|---|---|---|---|
| Arthralgia | 11.9 | 27.8 | 37.1 |
| Pain in extremity | 3.8 | 5.0 | 19.3 |
| Myalgia | 3.8 | 2.5 | 12.6 |
| Musculoskeletal stiffness | 1.9 | 3.8 | 8.0 |
| Joint stiffness | 1.3 | 3.8 | 7.7 |
| Joint swelling | 0.6 | 5.0 | 6.1 |
| Edema peripheral | 3.8 | 18.8 | 45.4 |
| Fatigue | 1.9 | 6.3 | 8.9 |
| Hypoesthesia | 0.6 | 8.8 | 15.0 |
| Paraesthesia | 2.5 | 12.5 | 11.0 |
| Blood glucose increased | 2.5 | 3.8 | 13.8 |
| Hyperglycemia | 0.6 | 8.8 | 7.1 |
| Fluid retention | 0.6 | 2.5 | 5.2 |
| Nausea | 2.5 | 1.3 | 6.1 |
HIV lipodystrophy is not an approved use; the label gives these studies for safety. First 12 weeks, 4 mg doses. The every-other-day arm was in one study only. About 26% on 4 mg daily and 19% on 4 mg every other day needed a dose reduction; 13% and 5% stopped because of side effects.
In the HIV wasting trial, hyperglycemia reported as a side effect was 3.6% on placebo, 1.9% on 0.1 mg/kg every other day and 3.2% on 0.1 mg/kg daily. One case of diabetes occurred on the daily dose in the first 12 weeks, and 3 more people stopped in the extension phase because diabetes developed.
Side effects in 1% to under 5% of people in the HIV wasting trial thought to be related to Serostim: dose-dependent edema, swelling around the eyes, carpal tunnel syndrome, high blood sugar and high triglycerides.
In the lipodystrophy studies, glucose-related side effects were 4% on placebo, 13% on 4 mg every other day and 22% on 4 mg daily. 23 people stopped because of high blood sugar (3.2% in the 12-week phases, 2.1% in the extension phases). Breast-related side effects were 1%, 3% and 6%.
After 12 weeks, none of the 651 people with HIV wasting treated with Serostim for the first time developed detectable antibodies to growth hormone.
In HIV wasting, 12 weeks of 0.1 mg/kg daily and every other day raised mean fasting blood glucose by about 10 mg/dL and 6 mg/dL, early in treatment.
In two placebo-controlled trials of 522 critically ill adults without growth hormone deficiency, deaths were 42% on somatropin (5.3-8 mg/day) vs 19% on placebo.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. People with acute critical illness after open heart or abdominal surgery, multiple injuries or acute respiratory failure; active cancer; a known allergy to somatropin or its ingredients; or active proliferative or severe non-proliferative diabetic eye disease.
Acute critical illness. Higher death rates have been reported in critically ill people given somatropin, so it is not started in them.
Antiretroviral therapy. Somatropin has made HIV multiply faster in some lab tests. No increase in viral load was seen in the trials, where everyone took antiretroviral therapy, and the label recommends staying on it for the whole Serostim course.
Tumors. Cancers are more common in people with HIV, so risks and benefits are weighed before starting and people are watched for new tumors, regrowth of past tumors and changes in moles.
Blood sugar and diabetes. New impaired glucose tolerance, new type 2 diabetes and worsening diabetes have been reported, some with diabetic ketoacidosis and coma. Some improved after stopping Serostim and some did not. People with other risk factors are watched closely.
Raised pressure in the skull. Intracranial hypertension with optic nerve swelling, vision changes, headache, nausea or vomiting has been reported, usually in the first 8 weeks. It resolved after stopping or lowering the dose. Eye exams are done before and during treatment.
Severe allergic reactions. Anaphylaxis and angioedema have been reported with somatropin products after approval. The label says prompt medical attention should be sought if an allergic reaction occurs.
Fluid retention and carpal tunnel. Swelling, especially of the hands and feet, and joint or muscle pain or stiffness may occur and may ease on their own, with pain relievers or with less frequent dosing. If carpal tunnel symptoms do not ease with fewer weekly doses, treatment is stopped.
Fat loss at injection sites. Injecting in the same spot for a long time can cause tissue atrophy, which the label says can be avoided by rotating sites.
Pancreatitis. Rare cases have been reported with somatropin. It is considered in anyone on somatropin who develops stomach pain.
From the Patient Counseling Information (section 17) and Warnings and Precautions (section 5); the SPL has no separate patient leaflet that comes with Serostim:
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.