Short answer: In the label's 26-week placebo-controlled trials, the most common reactions were injection site reactions (17% vs 6% on placebo), joint pain (13% vs 11%), pain in the arms or legs (6% vs 5%), muscle pain (6% vs 2%) and swelling of the legs (6% vs 2%). The label also warns about higher IGF-1 levels, fluid retention, raised blood sugar and allergic reactions. There is no boxed warning.
What Egrifta SV is approved for: Egrifta SV is approved to reduce excess abdominal fat in adults with HIV who have lipodystrophy. The label says it is not for weight loss management, its long-term heart and blood vessel safety has not been established, and there are no data that it improves how well people take their HIV medicines (section 1).
Source
EGRIFTA SV (tesamorelin) for injection, prescribing information and Patient Information. Theratechnologies. DailyMed, version published July 31, 2026. DailyMed setid 3d783378-b02d-4f19-99dd-0fc91a042224
No. The current Egrifta SV 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 Egrifta SV.
| Preferred term | Placebo (N=263) % | Egrifta (N=543) % |
|---|---|---|
| Injection site reaction* | 6 | 17 |
| Arthralgia | 11 | 13 |
| Pain in extremity | 5 | 6 |
| Myalgia | 2 | 6 |
| Edema peripheral | 2 | 6 |
| Paresthesia | 2 | 5 |
| Hypoesthesia | 2 | 4 |
| Rash | 2 | 4 |
| Dyspepsia | 1 | 2 |
| Musculoskeletal pain | 1 | 2 |
| Pain | 1 | 2 |
| Pruritus | 1 | 2 |
| Vomiting | 0 | 3 |
| Musculoskeletal stiffness | 0 | 2 |
These numbers come from trials of the original EGRIFTA (1 mg/vial formulation, 2 mg dose): 543 adults with HIV, lipodystrophy and excess abdominal fat on EGRIFTA and 263 on placebo during the first 26 weeks. The label says reactions with the 1.4 mg Egrifta SV dose are expected to be similar. *Injection site reaction includes redness, itching, rash, hives, pain, swelling, irritation and bleeding at the site. Shown here are the rows at 2% or more; the rest of the table is listed below.
The rest of Table 1, each at 1% on EGRIFTA and 0% on placebo: increased blood creatine phosphokinase, carpal tunnel syndrome, joint swelling, muscle strain, night sweats and palpitations.
Injection site reactions overall (redness, itching, pain, irritation, bruising): 25% of people on EGRIFTA vs 14% on placebo during the first 26 weeks.
HbA1c rose to 6.5% or higher by week 26 in 5% of people on EGRIFTA vs 1% on placebo, a hazard ratio of 3.3 (CI 1.4, 9.6). Mean starting HbA1c was 5.3% in both groups.
After 26 weeks, 47% had IGF-1 above 2 standard deviation scores (SDS) and 36% above 3 SDS, seen as early as week 13. Of those who stayed on for 52 weeks, 34% were above 2 SDS and 23% above 3 SDS at the end.
Allergic (hypersensitivity) reactions such as itching, redness, flushing, hives and rash happened in 4% of people treated with EGRIFTA in clinical trials.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Increased risk of tumors. Egrifta SV makes the body release its own growth hormone, a known growth factor. It must not be used with active cancer. With a past treated and stable cancer, the label calls for careful weighing of benefit against the risk of the cancer coming back, and Egrifta SV is stopped if there is any sign it has returned.
Higher IGF-1 levels. Egrifta SV raises IGF-1, and the effects of long-term high levels are unknown. IGF-1 is monitored during treatment, and stopping is considered if levels stay high (for example above 3 SDS), especially if the response is not strong.
Fluid retention. Fluid buildup can cause swelling, joint pain and carpal tunnel syndrome. The label says these are either temporary or go away when treatment is stopped.
Glucose intolerance or diabetes. Egrifta SV can raise blood sugar. Glucose status is checked before starting and periodically during treatment. People with diabetes are checked at regular intervals for new or worsening diabetic eye disease (retinopathy).
Allergic reactions. Itching, redness, flushing, hives and rash have been reported. If an allergic reaction is suspected, the label says to get prompt medical attention and stop Egrifta SV right away.
Injection site reactions. Redness, itching, pain, irritation and bruising can happen at the injection site. Rotating sites across different areas of the abdomen is the label's way to reduce them.
Critical illness. Higher death rates have been reported in people with acute critical illness (after open heart or abdominal surgery, multiple accidental injuries, or acute breathing failure) who were given growth hormone. Because Egrifta SV raises growth hormone, stopping it is considered in critically ill patients.
Who should not use it. People with pituitary problems (pituitary removal, low pituitary function, pituitary tumor or surgery, head radiation or head injury), active cancer, known allergy to tesamorelin or its ingredients, and pregnant women.
From the Patient Information that comes with Egrifta SV:
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.