TRIAL RESULTS · SIDE EFFECTS
Vosoritide side effects
ANSWER
In 1 placebo-controlled trial with posted results, the most common side effects of Vosoritide were injection site reaction 79.1% (placebo 40.6%), injection site erythema 76.7% (placebo 40.6%), viral infection 18.6% (placebo 12.5%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
1
with an arm on Vosoritide, of 23 registered
Against placebo
1
placebo-controlled trials
People in those trials
43
on Vosoritide · 32 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Vosoritide beside placebo
Share of people with each side effect in 1 placebo-controlled trial with posted results: 43 people on Vosoritide (all doses), 32 on placebo, same trials. Listed only when reported for at least half of the people on Vosoritide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
All 27 side effects reported
Every trial with posted results and an arm on Vosoritide (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 | Vosoritide | Placebo | Trials |
|---|---|---|---|---|
| Injection site reaction | General disorders | 79.1% (34 of 43) | 40.6% | 1 |
| Injection site erythema | General disorders | 76.7% (33 of 43) | 40.6% | 1 |
| Viral infection | Infections and infestations | 18.6% (8 of 43) | 12.5% | 1 |
| Injection site swelling | General disorders | 18.6% (8 of 43) | 6.3% | 1 |
| Fall | Injury, poisoning and procedural complications | 16.3% (7 of 43) | 9.4% | 1 |
| Injection site urticaria | General disorders | 14.0% (6 of 43) | 3.1% | 1 |
| Arthropod bite | Injury, poisoning and procedural complications | 14.0% (6 of 43) | 6.3% | 1 |
| Injection site induration | General disorders | 11.6% (5 of 43) | 0.0% | 1 |
| Constipation | Gastrointestinal disorders | 11.6% (5 of 43) | 6.3% | 1 |
| Rhinitis | Infections and infestations | 9.3% (4 of 43) | 0.0% | 1 |
| Lower respiratory tract infection | Infections and infestations | 9.3% (4 of 43) | 3.1% | 1 |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | 9.3% (4 of 43) | 3.1% | 1 |
| Viral upper respiratory tract infection | Infections and infestations | 7.0% (3 of 43) | 0.0% | 1 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 7.0% (3 of 43) | 0.0% | 1 |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | 7.0% (3 of 43) | 0.0% | 1 |
| Oxygen saturation decreased | Investigations | 2.3% (1 of 43) | 0.0% | 1 |
| Pneumonia | Infections and infestations | 2.3% (1 of 43) | 0.0% | 1 |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | 2.3% (1 of 43) | 0.0% | 1 |
| Sudden infant death syndrome | General disorders | 2.3% (1 of 43) | 0.0% | 1 |
| Petit mal epilepsy | Nervous system disorders | 0.0% (0 of 43) | 3.1% | 1 |
| Gastroenteritis | Infections and infestations | 0.0% (0 of 43) | 3.1% | 1 |
| Autism spectrum disorde | Psychiatric disorders | 0.0% (0 of 43) | 3.1% | 1 |
| Otitis media | Infections and infestations | 0.0% (0 of 43) | 3.1% | 1 |
| Parainfluenzae virus infection | Infections and infestations | 0.0% (0 of 43) | 3.1% | 1 |
| Vomiting | Gastrointestinal disorders | 0.0% (0 of 43) | 3.1% | 1 |
| Skull fracture | Injury, poisoning and procedural complications | 0.0% (0 of 43) | 3.1% | 1 |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 0.0% (0 of 43) | 3.1% | 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
VOXZOGO 0.4mg NDA214938 · label of 2025-11-25 Regulator
Most common adverse reactions (>10%) are injection site erythema, injection site swelling, rash, vomiting, injection site urticaria, arthralgia, decreased blood pressure, and gastroenteritis.
QUESTIONS
Does vosoritide cause injection site reaction?
In 1 placebo-controlled trial with posted results, 79.1% of people on vosoritide reported injection site reaction, against 40.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vosoritide cause injection site erythema?
In 1 placebo-controlled trial with posted results, 76.7% of people on vosoritide reported injection site erythema, against 40.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vosoritide cause viral infection?
In 1 placebo-controlled trial with posted results, 18.6% of people on vosoritide reported viral infection, against 12.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vosoritide cause injection site swelling?
In 1 placebo-controlled trial with posted results, 18.6% of people on vosoritide reported injection site swelling, against 6.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does vosoritide cause fall?
In 1 placebo-controlled trial with posted results, 16.3% of people on vosoritide reported fall, against 9.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
23 registered clinical trials of Vosoritide
The 10 most recently updated are listed.
| NCT07441876 | Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia Status: RECRUITING · Updated 2026-09-24 |
|---|---|
| NCT06668805 | A Study of Vosoritide in Children With Noonan Syndrome With Inadequate Growth During or After Human Growth Hormone Treatment Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-23 |
| 2024-512261-14-00 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Vosoritide in Infants and Young Children with Hypochondroplasia, Aged 0 to < 36 Months Status: UNKNOWN · Updated 2026-09-17 |
| NCT07073014 | Long-Term Extension Study of Vosoritide to Treat Children With Hypochondroplasia Status: ENROLLING_BY_INVITATION · Updated 2026-09-09 |
| 2024-520137-74-00 | A Phase 2, Randomized, Controlled, Multicenter Study of Vosoritide in Children With Idiopathic Short Stature Status: UNKNOWN · Updated 2026-08-06 |
| 2024-517238-16-00 | A Phase 3, Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Vosoritide in Children with Hypochondroplasia Status: UNKNOWN · Updated 2026-07-03 |
| 2024-515861-33-00 | A Phase 2, Randomized, Multicenter, Study of Vosoritide in Children with Noonan Syndrome with Inadequate Growth During or After Human Growth Hormone Treatment Status: UNKNOWN · Updated 2026-06-24 |
| NCT06382155 | A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature Status: RECRUITING · Updated 2026-05-22 |
| 2024-513129-22-00 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vosoritide in Children with Hypochondroplasia Status: UNKNOWN · Updated 2026-05-19 |
| 2025-523811-12-00 | A Multicenter, Randomized, Operationally Seamless Phase 2/3 Study to Evaluate the Efficacy and Safety of BMN 333 versus Vosoritide in Children with Achondroplasia Status: UNKNOWN · Updated 2026-05-05 |
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