Drug
Velaglucerase Alfa
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Poor Venous Access | 66 | 65.8 | 68.0 | signal |
| 2 | Weight Fluctuation | 37 | 36.5 | 37.1 | signal |
| 3 | Insurance Issue | 49 | 33.9 | 34.7 | signal |
| 4 | Product Availability Issue | 64 | 29.3 | 30.2 | signal |
| 5 | Pregnancy | 46 | 23.3 | 23.8 | signal |
| 6 | Splenomegaly | 19 | 16.6 | 16.8 | signal |
| 7 | Infusion Related Reaction | 102 | 15.8 | 16.6 | signal |
| 8 | Bone Pain | 89 | 15.6 | 16.2 | signal |
| 9 | Infusion Site Pain | 16 | 12.8 | 12.9 | signal |
| 10 | Inappropriate Schedule Of Product Administration | 212 | 12.3 | 13.6 | signal |
| 11 | Inability To Afford Medication | 11 | 11.5 | 11.5 | signal |
| 12 | Blood Pressure Abnormal | 21 | 10.9 | 11.0 | signal |
| 13 | Body Height Decreased | 11 | 10.4 | 10.5 | signal |
| 14 | Hepatomegaly | 10 | 10.4 | 10.4 | signal |
| 15 | Product Prescribing Error | 23 | 9.9 | 10.1 | signal |
| 16 | Covid-19 | 167 | 9.7 | 10.4 | signal |
| 17 | Wrist Fracture | 11 | 9.4 | 9.4 | signal |
| 18 | Upper Limb Fracture | 18 | 9.2 | 9.3 | signal |
| 19 | Abortion Spontaneous | 36 | 9.2 | 9.3 | signal |
| 20 | Osteonecrosis | 29 | 9.0 | 9.1 | signal |
| 21 | Exposure During Pregnancy | 54 | 8.9 | 9.1 | signal |
| 22 | Appendicitis | 8 | 8.8 | 8.8 | signal |
| 23 | Flank Pain | 8 | 8.8 | 8.8 | signal |
| 24 | Pharyngitis Streptococcal | 9 | 8.5 | 8.5 | signal |
| 25 | Body Temperature Increased | 16 | 8.0 | 8.1 | signal |
| 26 | Rib Fracture | 16 | 8.0 | 8.0 | signal |
| 27 | Femur Fracture | 24 | 7.9 | 8.0 | signal |
| 28 | Retinal Detachment | 7 | 7.8 | 7.8 | signal |
| 29 | Sciatica | 12 | 7.7 | 7.8 | signal |
| 30 | Myoclonus | 9 | 7.7 | 7.8 | signal |
| 31 | Skin Infection | 8 | 7.3 | 7.4 | signal |
| 32 | Ligament Sprain | 7 | 7.3 | 7.3 | signal |
| 33 | Blood Pressure Fluctuation | 17 | 7.2 | 7.3 | signal |
| 34 | Product Dose Omission Issue | 198 | 7.1 | 7.8 | signal |
| 35 | Lower Limb Fracture | 13 | 7.0 | 7.0 | signal |
| 36 | Treatment Noncompliance | 36 | 6.8 | 6.9 | signal |
| 37 | Skin Laceration | 7 | 6.6 | 6.7 | signal |
| 38 | Ankle Fracture | 10 | 6.6 | 6.6 | signal |
| 39 | Seasonal Allergy | 9 | 6.5 | 6.6 | signal |
| 40 | Cholelithiasis | 20 | 6.2 | 6.3 | signal |
| 41 | Body Temperature Decreased | 6 | 6.2 | 6.2 | signal |
| 42 | Spinal Pain | 7 | 6.1 | 6.1 | signal |
| 43 | Blood Iron Decreased | 7 | 6.1 | 6.1 | signal |
| 44 | Joint Dislocation | 6 | 5.8 | 5.8 | signal |
| 45 | Epilepsy | 17 | 5.7 | 5.7 | signal |
| 46 | Gout | 10 | 5.7 | 5.7 | signal |
| 47 | Bone Disorder | 10 | 5.6 | 5.6 | signal |
| 48 | Rotator Cuff Syndrome | 7 | 5.6 | 5.6 | signal |
| 49 | Increased Tendency To Bruise | 5 | 5.6 | 5.6 | signal |
| 50 | Psychomotor Hyperactivity | 9 | 5.5 | 5.5 | signal |
| 51 | Hepatic Cirrhosis | 10 | 5.5 | 5.5 | signal |
| 52 | Personality Change | 5 | 5.5 | 5.5 | signal |
| 53 | Road Traffic Accident | 22 | 5.4 | 5.4 | signal |
| 54 | Post Procedural Haemorrhage | 6 | 5.3 | 5.3 | signal |
| 55 | Basal Cell Carcinoma | 8 | 5.2 | 5.3 | signal |
| 56 | Influenza | 56 | 5.1 | 5.2 | signal |
| 57 | Ovarian Cyst | 5 | 5.1 | 5.1 | signal |
| 58 | Localised Infection | 12 | 5.1 | 5.1 | signal |
| 59 | Muscle Tightness | 8 | 5.1 | 5.1 | signal |
| 60 | Limb Injury | 13 | 4.9 | 4.9 | signal |
| 61 | Weight Increased | 106 | 4.9 | 5.1 | signal |
| 62 | Heart Rate Decreased | 16 | 4.6 | 4.7 | signal |
| 63 | Sars-cov-2 Test Positive | 6 | 4.6 | 4.6 | signal |
| 64 | Inappropriate Schedule Of Drug Administration | 31 | 4.4 | 4.4 | signal |
| 65 | Illness | 41 | 4.2 | 4.2 | signal |
| 66 | Coeliac Disease | 4 | 4.2 | 4.2 | signal |
| 67 | Mood Altered | 11 | 4.1 | 4.2 | signal |
| 68 | Plasma Cell Myeloma | 15 | 3.9 | 3.9 | signal |
| 69 | Malignant Melanoma | 5 | 3.8 | 3.8 | signal |
| 70 | Status Epilepticus | 4 | 3.6 | 3.6 | signal |
| 71 | Product Prescribing Issue | 7 | 3.5 | 3.5 | signal |
| 72 | No Adverse Event | 58 | 3.3 | 3.4 | signal |
| 73 | Brain Neoplasm | 3 | 3.3 | 3.3 | no signal |
| 74 | Abortion Induced | 3 | 3.3 | 3.3 | no signal |
| 75 | Eye Inflammation | 3 | 3.3 | 3.3 | no signal |
| 76 | Complication Associated With Device | 4 | 3.1 | 3.1 | no signal |
| 77 | Product Preparation Error | 6 | 3.0 | 3.0 | signal |
| 78 | Central Nervous System Lesion | 4 | 3.0 | 3.0 | no signal |
| 79 | Hepatic Cancer | 7 | 3.0 | 3.0 | signal |
| 80 | Incorrect Product Administration Duration | 5 | 2.5 | 2.5 | no signal |
| 81 | Dysmenorrhoea | 3 | 2.3 | 2.3 | no signal |
| 82 | Product Storage Error | 17 | 2.0 | 2.0 | signal |
| 83 | Gastric Cancer | 5 | 2.0 | 2.0 | no signal |
| 84 | Incorrect Dose Administered | 43 | 2.0 | 2.0 | no signal |
| 85 | Pancreatic Carcinoma | 5 | 1.8 | 1.8 | no signal |
| 86 | Menstruation Irregular | 4 | 1.5 | 1.5 | no signal |
| 87 | Oesophageal Carcinoma | 4 | 1.4 | 1.4 | no signal |
| 88 | Device Issue | 9 | 1.1 | 1.1 | no signal |