TRIAL RESULTS · SIDE EFFECTS
Tesamorelin side effects
ANSWER
In 4 placebo-controlled trials with posted results, the most common side effects of Tesamorelin were injection site erythema 6.8% (placebo 2.6%), paresthesia 2.4% (placebo 5.0%), injection site pain 1.8% (placebo 2.5%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
4
with an arm on Tesamorelin, of 24 registered
Against placebo
4
placebo-controlled trials
People in those trials
220
on Tesamorelin · 248 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Tesamorelin beside placebo
Share of people with each side effect in 4 placebo-controlled trials with posted results: 220 people on Tesamorelin (all doses), 248 on placebo, same trials. Listed only when reported for at least half of the people on Tesamorelin. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
All 96 side effects reported
Every trial with posted results and an arm on Tesamorelin (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Tesamorelin | Placebo | Trials |
|---|---|---|---|---|
| Fasting blood glucose increased | Investigations | 35.1% (26 of 74) | 36.7% | 1 |
| Injection site bruising | General disorders | 16.0% (16 of 100) | 21.8% | 2 |
| Injection site stinging | General disorders | 16.0% (16 of 100) | 3.6% | 2 |
| Alanine aminotransferase increased | Investigations | 14.9% (11 of 74) | 16.7% | 1 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 10.0% (10 of 100) | 7.3% | 2 |
| injection site bruising | Skin and subcutaneous tissue disorders | 35.7% (10 of 28) | 50.0% | 1 |
| Injection site erythema | General disorders | 6.8% (8 of 118) | 2.6% | 2 |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | 8.7% (8 of 92) | 4.1% | 1 |
| URTI (upper respiratory tract infection) | Infections and infestations | 10.8% (8 of 74) | 16.7% | 1 |
| Hypertriglyceridemia | Metabolism and nutrition disorders | 9.5% (7 of 74) | 10.0% | 1 |
| Injection site itching | General disorders | 6.0% (6 of 100) | 1.8% | 2 |
| Injection site redness | General disorders | 6.0% (6 of 100) | 0.0% | 2 |
| paresthesia | Nervous system disorders | 21.4% (6 of 28) | 4.5% | 1 |
| Aspartate aminotransferase increased | Investigations | 8.1% (6 of 74) | 6.7% | 1 |
| Edema | Skin and subcutaneous tissue disorders | 23.1% (6 of 26) | 4.0% | 1 |
| Rash | Skin and subcutaneous tissue disorders | 5.0% (5 of 100) | 0.0% | 2 |
| Alkaline phosphatase increased | Investigations | 6.8% (5 of 74) | 0.0% | 1 |
| Injection site complaints, other | Skin and subcutaneous tissue disorders | 19.2% (5 of 26) | 8.0% | 1 |
| Paresthesia | Nervous system disorders | 2.4% (4 of 166) | 5.0% | 2 |
| erythema at injection site | Skin and subcutaneous tissue disorders | 14.3% (4 of 28) | 9.1% | 1 |
| joint pain | Musculoskeletal and connective tissue disorders | 14.3% (4 of 28) | 18.2% | 1 |
| Hypercholesterolemia | Metabolism and nutrition disorders | 5.4% (4 of 74) | 3.3% | 1 |
| Injection site induration | General disorders | 5.4% (4 of 74) | 0.0% | 1 |
| Pain post biopsy | Injury, poisoning and procedural complications | 5.4% (4 of 74) | 0.0% | 1 |
| Injection site pain | General disorders | 1.8% (3 of 166) | 2.5% | 2 |
| Fall | Injury, poisoning and procedural complications | 3.0% (3 of 100) | 3.6% | 2 |
| Diarrhoea | Gastrointestinal disorders | 3.3% (3 of 92) | 5.3% | 1 |
| stinging of skin | Skin and subcutaneous tissue disorders | 10.7% (3 of 28) | 0.0% | 1 |
| muscle pain | Musculoskeletal and connective tissue disorders | 10.7% (3 of 28) | 0.0% | 1 |
| Fracture | Injury, poisoning and procedural complications | 4.1% (3 of 74) | 3.3% | 1 |
| Hyper LDL cholesterolemia | Metabolism and nutrition disorders | 4.1% (3 of 74) | 6.7% | 1 |
| Myalgia | Musculoskeletal and connective tissue disorders | 4.1% (3 of 74) | 0.0% | 1 |
| Pneumonia | Infections and infestations | 4.1% (3 of 74) | 3.3% | 1 |
| Tooth Infection | Infections and infestations | 4.1% (3 of 74) | 3.3% | 1 |
| Joint pain | Musculoskeletal and connective tissue disorders | 11.5% (3 of 26) | 4.0% | 1 |
| hyperglycemia | Endocrine disorders | 7.1% (2 of 28) | 9.1% | 1 |
| edema | Blood and lymphatic system disorders | 7.1% (2 of 28) | 4.5% | 1 |
| sinusitis | Infections and infestations | 7.1% (2 of 28) | 4.5% | 1 |
| Cellulitis | Infections and infestations | 2.7% (2 of 74) | 3.3% | 1 |
| Fatigue | General disorders | 2.7% (2 of 74) | 3.3% | 1 |
| Sinusitis | Infections and infestations | 2.7% (2 of 74) | 10.0% | 1 |
| Viral infection | Infections and infestations | 2.7% (2 of 74) | 6.7% | 1 |
| Gastrointeritis | Gastrointestinal disorders | 7.7% (2 of 26) | 0.0% | 1 |
| Abdominal pain | Gastrointestinal disorders | 0.6% (1 of 166) | 1.5% | 2 |
| Nephrolithiasis | Renal and urinary disorders | 0.8% (1 of 118) | 0.5% | 2 |
| Musculosketal stiffness | Musculoskeletal and connective tissue disorders | 1.1% (1 of 92) | 2.9% | 1 |
| Retinopathy | Eye disorders | 1.1% (1 of 92) | 0.0% | 1 |
| Chest pain | General disorders | 1.1% (1 of 92) | 0.0% | 1 |
| Mental status changes | Psychiatric disorders | 1.1% (1 of 92) | 0.0% | 1 |
| Congestive Heart Failure | Cardiac disorders | 3.6% (1 of 28) | 0.0% | 1 |
| pneumonia | Respiratory, thoracic and mediastinal disorders | 3.6% (1 of 28) | 0.0% | 1 |
| basal cell carcinoma | Skin and subcutaneous tissue disorders | 3.6% (1 of 28) | 4.5% | 1 |
| Nonspecific abnormal findings on radiological and other examinations | Investigations | 1.4% (1 of 74) | 6.7% | 1 |
| Hemiplegia transient | Nervous system disorders | 1.4% (1 of 74) | 0.0% | 1 |
| Anxiety Depression | Psychiatric disorders | 1.4% (1 of 74) | 0.0% | 1 |
| Drug overdose | Injury, poisoning and procedural complications | 1.4% (1 of 74) | 0.0% | 1 |
| Soft tissue infection | Infections and infestations | 1.4% (1 of 74) | 0.0% | 1 |
| Urosepsis | Infections and infestations | 1.4% (1 of 74) | 0.0% | 1 |
| Active suicidal ideation | Psychiatric disorders | 1.4% (1 of 74) | 0.0% | 1 |
| Death sudden | General disorders | 1.4% (1 of 74) | 0.0% | 1 |
| Acne | Skin and subcutaneous tissue disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Diarrhea | Gastrointestinal disorders | 3.8% (1 of 26) | 0.0% | 1 |
| fever | Infections and infestations | 3.8% (1 of 26) | 0.0% | 1 |
| Galactorrhea | Endocrine disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Headache | Nervous system disorders | 3.8% (1 of 26) | 12.0% | 1 |
| Hyperglycemia | Endocrine disorders | 3.8% (1 of 26) | 4.0% | 1 |
| Loose stool | Gastrointestinal disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Mild loss of coordination | Nervous system disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Motor vehicle accident | Injury, poisoning and procedural complications | 3.8% (1 of 26) | 0.0% | 1 |
| Nocturia | Renal and urinary disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Infection (unspecified) | Infections and infestations | 3.8% (1 of 26) | 4.0% | 1 |
| Hyperparathyroidism | Endocrine disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Dizziness | Nervous system disorders | 3.8% (1 of 26) | 0.0% | 1 |
| Lower extremity venous thrombosis | Blood and lymphatic system disorders | 3.8% (1 of 26) | 0.0% | 1 |
| elective knee replacement | Surgical and medical procedures | 3.8% (1 of 26) | 0.0% | 1 |
| liver hematoma following biopsy | Injury, poisoning and procedural complications | 3.8% (1 of 26) | 0.0% | 1 |
| Insomnia | Psychiatric disorders | 0.0% (0 of 92) | 2.9% | 1 |
| Hodgkin disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.0% (0 of 92) | 0.6% | 1 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0.0% (0 of 92) | 0.6% | 1 |
| esophageal myotomy | Gastrointestinal disorders | 0.0% (0 of 28) | 4.5% | 1 |
| cerebrovascular accident | Vascular disorders | 0.0% (0 of 28) | 4.5% | 1 |
| Hepatic Hematoma | Hepatobiliary disorders | 0.0% (0 of 74) | 3.3% | 1 |
| Suicide attempt | Psychiatric disorders | 0.0% (0 of 74) | 3.3% | 1 |
| Abdominal Pain | Gastrointestinal disorders | 0.0% (0 of 26) | 4.0% | 1 |
| Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | 0.0% (0 of 26) | 4.0% | 1 |
| Concussion | Nervous system disorders | 0.0% (0 of 26) | 4.0% | 1 |
| elevated gamma glutamyl transferase | Hepatobiliary disorders | 0.0% (0 of 26) | 4.0% | 1 |
| Pain following liver biopsy | Injury, poisoning and procedural complications | 0.0% (0 of 26) | 4.0% | 1 |
| renal cyst | Renal and urinary disorders | 0.0% (0 of 26) | 4.0% | 1 |
| Vertebral fractures (from fall) | Musculoskeletal and connective tissue disorders | 0.0% (0 of 26) | 4.0% | 1 |
| Wisdom teeth extraction | Surgical and medical procedures | 0.0% (0 of 26) | 0.0% | 1 |
| Urine discoloration | Renal and urinary disorders | 0.0% (0 of 26) | 0.0% | 1 |
| rotator cuff surgery | Surgical and medical procedures | 0.0% (0 of 26) | 4.0% | 1 |
| appendicitis | Gastrointestinal disorders | 0.0% (0 of 26) | 4.0% | 1 |
| major depressive disorder | Psychiatric disorders | 0.0% (0 of 26) | 4.0% | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
EGRIFTA SV BLA022505 · label of 2026-07-29 Regulator
Serious reactions the label warns about: Increased risk of neoplasms, Elevated IGF-1 levels, Fluid retention, Glucose intolerance or diabetes mellitus, Hypersensitivity reactions, Injection site reactions.
EGRIFTA WR BLA022505 · label of 2026-07-29 Regulator
Serious reactions the label warns about: Increased risk of neoplasms, Elevated IGF-1 levels, Fluid retention, Glucose intolerance or diabetes mellitus, Hypersensitivity reactions, Injection site reactions.
QUESTIONS
Does tesamorelin cause injection site erythema?
In 4 placebo-controlled trials with posted results, 6.8% of people on tesamorelin reported injection site erythema, against 2.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does tesamorelin cause paresthesia?
In 4 placebo-controlled trials with posted results, 2.4% of people on tesamorelin reported paresthesia, against 5.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does tesamorelin cause injection site pain?
In 4 placebo-controlled trials with posted results, 1.8% of people on tesamorelin reported injection site pain, against 2.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does tesamorelin cause nephrolithiasis?
In 4 placebo-controlled trials with posted results, 0.8% of people on tesamorelin reported nephrolithiasis, against 0.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does tesamorelin cause abdominal pain?
In 4 placebo-controlled trials with posted results, 0.6% of people on tesamorelin reported abdominal pain, against 1.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
24 registered clinical trials of Tesamorelin
The 10 most recently updated are listed.
| NCT03226821 | Body Composition and Adipose Tissue in HIV Status: TERMINATED · Updated 2026-05-19 |
|---|---|
| NCT06554717 | Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV Status: RECRUITING · Updated 2026-05-19 |
| NCT07481734 | Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) Status: RECRUITING · Updated 2026-03-19 |
| NCT02572323 | Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons Status: COMPLETED · Updated 2026-03-12 |
| NCT03375788 | Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk Status: COMPLETED · Updated 2025-11-20 |
| NCT03150511 | Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury Status: RECRUITING · Updated 2025-11-12 |
| NCT00608023 | TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy Status: COMPLETED · Updated 2022-09-30 |
| NCT03826160 | Growth Hormone Dynamics and Cardiac Steatosis in HIV Status: COMPLETED · Updated 2022-07-19 |
| NCT01388920 | Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting Status: TERMINATED · Updated 2022-03-18 |
| NCT02196831 | Tesamorelin Effects on Liver Fat and Histology in HIV Status: COMPLETED · Updated 2020-01-27 |
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