Drug
Imiglucerase
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 | 60 | 26.1 | 26.4 | signal |
| 2 | Splenomegaly | 66 | 25.3 | 25.6 | signal |
| 3 | Status Epilepticus | 39 | 15.4 | 15.5 | signal |
| 4 | Hepatomegaly | 34 | 15.4 | 15.5 | signal |
| 5 | Bone Disorder | 48 | 11.7 | 11.8 | signal |
| 6 | Exposure During Pregnancy | 162 | 11.6 | 12.0 | signal |
| 7 | Osteonecrosis | 85 | 11.5 | 11.7 | signal |
| 8 | Bone Pain | 147 | 11.2 | 11.5 | signal |
| 9 | Epilepsy | 62 | 9.1 | 9.2 | signal |
| 10 | Cyanosis | 32 | 9.1 | 9.1 | signal |
| 11 | Hip Arthroplasty | 28 | 8.2 | 8.3 | signal |
| 12 | Convulsion | 103 | 7.9 | 8.1 | signal |
| 13 | Abortion Spontaneous | 70 | 7.8 | 7.9 | signal |
| 14 | Aspiration | 18 | 7.4 | 7.4 | signal |
| 15 | Myoclonus | 19 | 7.1 | 7.1 | signal |
| 16 | Pulmonary Hypertension | 32 | 6.8 | 6.9 | signal |
| 17 | Malnutrition | 17 | 6.8 | 6.9 | signal |
| 18 | Device Related Infection | 22 | 6.4 | 6.4 | signal |
| 19 | Drug Exposure During Pregnancy | 48 | 6.2 | 6.3 | signal |
| 20 | Pregnancy | 28 | 6.2 | 6.2 | signal |
| 21 | Caesarean Section | 16 | 6.1 | 6.1 | signal |
| 22 | Respiratory Failure | 95 | 5.8 | 5.9 | signal |
| 23 | Femur Fracture | 40 | 5.7 | 5.8 | signal |
| 24 | Weight Fluctuation | 13 | 5.6 | 5.6 | signal |
| 25 | Pneumonia Aspiration | 31 | 5.6 | 5.6 | signal |
| 26 | Infusion Site Pain | 15 | 5.2 | 5.3 | signal |
| 27 | Osteomyelitis | 21 | 5.2 | 5.2 | signal |
| 28 | Respiratory Distress | 32 | 5.2 | 5.2 | signal |
| 29 | Lung Infection | 18 | 5.1 | 5.1 | signal |
| 30 | Hepatic Cirrhosis | 21 | 5.0 | 5.0 | signal |
| 31 | Sudden Death | 12 | 5.0 | 5.0 | signal |
| 32 | Disease Progression | 128 | 4.8 | 5.0 | signal |
| 33 | Respiratory Disorder | 32 | 4.8 | 4.8 | signal |
| 34 | Respiratory Arrest | 28 | 4.5 | 4.5 | signal |
| 35 | Nervous System Disorder | 31 | 4.4 | 4.4 | signal |
| 36 | Sars-cov-2 Test Positive | 13 | 4.3 | 4.4 | signal |
| 37 | Tachypnoea | 13 | 4.3 | 4.3 | signal |
| 38 | Upper Limb Fracture | 19 | 4.2 | 4.2 | signal |
| 39 | Choking | 18 | 4.1 | 4.1 | signal |
| 40 | Parkinsonism | 9 | 4.1 | 4.1 | signal |
| 41 | Wrist Fracture | 11 | 4.1 | 4.1 | signal |
| 42 | Hip Fracture | 29 | 4.0 | 4.0 | signal |
| 43 | Respiratory Tract Infection | 23 | 4.0 | 4.0 | signal |
| 44 | Maternal Exposure During Pregnancy | 76 | 3.8 | 3.9 | signal |
| 45 | Lower Respiratory Tract Infection | 39 | 3.8 | 3.9 | signal |
| 46 | Arthropathy | 48 | 3.8 | 3.9 | signal |
| 47 | Pharyngitis Streptococcal | 9 | 3.7 | 3.7 | signal |
| 48 | Haematemesis | 21 | 3.7 | 3.7 | signal |
| 49 | Hepatitis C | 10 | 3.7 | 3.7 | signal |
| 50 | Infusion Related Reaction | 54 | 3.6 | 3.7 | signal |
| 51 | Pallor | 22 | 3.6 | 3.6 | signal |
| 52 | Intentional Dose Omission | 22 | 3.6 | 3.6 | signal |
| 53 | Joint Injury | 17 | 3.5 | 3.6 | signal |
| 54 | Osteopenia | 12 | 3.5 | 3.5 | signal |
| 55 | Staphylococcal Infection | 26 | 3.5 | 3.5 | signal |
| 56 | Bronchospasm | 11 | 3.4 | 3.4 | signal |
| 57 | Anorexia | 10 | 3.4 | 3.4 | signal |
| 58 | Hypokinesia | 11 | 3.4 | 3.4 | signal |
| 59 | Accident | 9 | 3.4 | 3.4 | signal |
| 60 | Appendicitis | 7 | 3.4 | 3.4 | signal |
| 61 | Grand Mal Convulsion | 7 | 3.3 | 3.3 | signal |
| 62 | Platelet Count Decreased | 79 | 3.3 | 3.3 | signal |
| 63 | Multi-organ Failure | 13 | 3.3 | 3.3 | signal |
| 64 | Generalised Tonic-clonic Seizure | 12 | 3.3 | 3.3 | signal |
| 65 | Cholelithiasis | 24 | 3.3 | 3.3 | signal |
| 66 | Post Procedural Complication | 14 | 3.2 | 3.3 | signal |
| 67 | No Therapeutic Response | 9 | 3.2 | 3.2 | signal |
| 68 | Product Preparation Error | 15 | 3.2 | 3.2 | signal |
| 69 | Viral Infection | 24 | 3.2 | 3.2 | signal |
| 70 | Upper Respiratory Tract Infection | 33 | 3.2 | 3.2 | signal |
| 71 | Weight Increased | 159 | 3.2 | 3.3 | signal |
| 72 | Cardio-respiratory Arrest | 30 | 3.2 | 3.2 | signal |
| 73 | Disseminated Intravascular Coagulation | 10 | 3.2 | 3.2 | signal |
| 74 | Dialysis | 10 | 3.1 | 3.1 | signal |
| 75 | Road Traffic Accident | 29 | 3.1 | 3.1 | signal |
| 76 | Platelet Count Increased | 9 | 3.1 | 3.1 | signal |
| 77 | Fracture | 13 | 3.1 | 3.1 | signal |
| 78 | Body Temperature Increased | 14 | 3.1 | 3.1 | signal |
| 79 | Foot Fracture | 13 | 3.0 | 3.1 | signal |
| 80 | Eyelid Oedema | 8 | 3.0 | 3.1 | signal |
| 81 | Retinal Detachment | 6 | 2.9 | 2.9 | signal |
| 82 | Lymphoma | 10 | 2.9 | 2.9 | signal |
| 83 | Hepatic Encephalopathy | 6 | 2.9 | 2.9 | signal |
| 84 | Ear Infection | 17 | 2.9 | 2.9 | signal |
| 85 | Intervertebral Disc Protrusion | 14 | 2.8 | 2.9 | signal |
| 86 | Seizure | 73 | 2.8 | 2.9 | signal |
| 87 | Rib Fracture | 13 | 2.8 | 2.8 | signal |
| 88 | Treatment Noncompliance | 34 | 2.8 | 2.8 | signal |
| 89 | Septic Shock | 27 | 2.8 | 2.8 | signal |
| 90 | Acute Respiratory Distress Syndrome | 11 | 2.8 | 2.8 | signal |
| 91 | Pyrexia | 213 | 2.7 | 2.8 | signal |
| 92 | Ascites | 18 | 2.7 | 2.7 | signal |
| 93 | Thrombocytopenia | 67 | 2.7 | 2.7 | signal |
| 94 | Device Failure | 9 | 2.6 | 2.6 | signal |
| 95 | Osteoporosis | 24 | 2.6 | 2.6 | signal |
| 96 | Petechiae | 6 | 2.6 | 2.6 | signal |
| 97 | Lower Limb Fracture | 11 | 2.6 | 2.6 | signal |
| 98 | Metastases To Liver | 10 | 2.5 | 2.5 | signal |
| 99 | Joint Dislocation | 6 | 2.5 | 2.5 | signal |
| 100 | Hepatic Failure | 17 | 2.5 | 2.5 | signal |
| 101 | Pharyngitis | 7 | 2.5 | 2.5 | signal |
| 102 | Gout | 10 | 2.5 | 2.5 | signal |
| 103 | Throat Tightness | 15 | 2.5 | 2.5 | signal |
| 104 | Myelodysplastic Syndrome | 8 | 2.5 | 2.5 | signal |
| 105 | Gastroenteritis Viral | 10 | 2.5 | 2.5 | signal |
| 106 | Increased Tendency To Bruise | 5 | 2.4 | 2.4 | no signal |
| 107 | Bronchitis | 40 | 2.4 | 2.4 | signal |
| 108 | Oxygen Saturation Decreased | 30 | 2.4 | 2.4 | signal |
| 109 | Colon Cancer | 8 | 2.4 | 2.4 | signal |
| 110 | Immune System Disorder | 7 | 2.4 | 2.4 | signal |
| 111 | Circulatory Collapse | 9 | 2.3 | 2.3 | signal |
| 112 | Metastases To Lung | 6 | 2.3 | 2.3 | no signal |
| 113 | Fall | 170 | 2.3 | 2.3 | signal |
| 114 | Lymphadenopathy | 18 | 2.3 | 2.3 | signal |
| 115 | Respiratory Tract Congestion | 8 | 2.2 | 2.2 | signal |
| 116 | Muscle Rigidity | 6 | 2.2 | 2.2 | no signal |
| 117 | Blood Lactate Dehydrogenase Increased | 8 | 2.2 | 2.2 | signal |
| 118 | Spinal Fracture | 10 | 2.2 | 2.2 | signal |
| 119 | Hypotonia | 5 | 2.2 | 2.2 | no signal |
| 120 | Cardiac Arrest | 40 | 2.2 | 2.2 | signal |
| 121 | Multiple Fractures | 8 | 2.2 | 2.2 | no signal |
| 122 | Limb Injury | 13 | 2.1 | 2.1 | signal |
| 123 | Incorrect Route Of Product Administration | 8 | 2.1 | 2.1 | no signal |
| 124 | Bone Density Decreased | 15 | 2.1 | 2.1 | signal |
| 125 | Dementia | 13 | 2.1 | 2.1 | signal |
| 126 | Tuberculosis | 6 | 2.1 | 2.1 | no signal |
| 127 | Kidney Infection | 9 | 2.0 | 2.0 | no signal |
| 128 | Bedridden | 6 | 2.0 | 2.0 | no signal |
| 129 | Epistaxis | 34 | 2.0 | 2.0 | signal |
| 130 | Pancytopenia | 25 | 2.0 | 2.0 | signal |
| 131 | Obstructive Airways Disorder | 5 | 2.0 | 2.0 | no signal |
| 132 | Gallbladder Disorder | 8 | 2.0 | 2.0 | no signal |
| 133 | Cholecystectomy | 5 | 2.0 | 2.0 | no signal |
| 134 | Abasia | 11 | 2.0 | 2.0 | no signal |
| 135 | Gingival Bleeding | 6 | 2.0 | 2.0 | no signal |
| 136 | Illness | 44 | 2.0 | 2.0 | no signal |
| 137 | Cardiac Failure | 35 | 1.9 | 1.9 | no signal |
| 138 | Nerve Compression | 4 | 1.9 | 1.9 | no signal |
| 139 | Ovarian Cancer | 4 | 1.9 | 1.9 | no signal |
| 140 | Blindness Unilateral | 6 | 1.9 | 1.9 | no signal |
| 141 | Product Dose Omission | 28 | 1.9 | 1.9 | no signal |
| 142 | Ataxia | 5 | 1.9 | 1.9 | no signal |
| 143 | Nasopharyngitis | 77 | 1.9 | 1.9 | no signal |
| 144 | Influenza | 46 | 1.8 | 1.8 | no signal |
| 145 | Haemorrhage Intracranial | 6 | 1.8 | 1.8 | no signal |
| 146 | Subarachnoid Haemorrhage | 4 | 1.7 | 1.7 | no signal |
| 147 | Eye Discharge | 4 | 1.7 | 1.7 | no signal |
| 148 | Knee Arthroplasty | 8 | 1.7 | 1.7 | no signal |
| 149 | Breast Cancer Metastatic | 4 | 1.7 | 1.7 | no signal |
| 150 | Hospitalisation | 56 | 1.6 | 1.6 | no signal |
| 151 | Fistula | 4 | 1.6 | 1.6 | no signal |
| 152 | Inappropriate Schedule Of Product Administration | 57 | 1.4 | 1.4 | no signal |
| 153 | Cardiac Disorder | 30 | 1.4 | 1.4 | no signal |
| 154 | Metastases To Central Nervous System | 4 | 1.4 | 1.4 | no signal |
| 155 | Hernia | 6 | 1.4 | 1.4 | no signal |
| 156 | Ovarian Cyst | 3 | 1.3 | 1.3 | no signal |
| 157 | Breast Cancer Female | 8 | 1.3 | 1.3 | no signal |
| 158 | Haemorrhage | 31 | 1.3 | 1.3 | no signal |
| 159 | Coronary Artery Occlusion | 4 | 1.3 | 1.3 | no signal |
| 160 | Pulmonary Arterial Hypertension | 4 | 1.2 | 1.2 | no signal |
| 161 | Internal Haemorrhage | 3 | 1.2 | 1.2 | no signal |
| 162 | Neoplasm Malignant | 17 | 1.1 | 1.1 | no signal |
| 163 | Activities Of Daily Living Impaired | 5 | 1.1 | 1.1 | no signal |
| 164 | Thyroid Cancer | 3 | 1.1 | 1.1 | no signal |
| 165 | Muscle Spasticity | 3 | 1.1 | 1.1 | no signal |
| 166 | Cytomegalovirus Infection | 4 | 1.1 | 1.1 | no signal |
| 167 | Drug Dose Omission | 39 | 1.0 | 1.0 | no signal |
| 168 | Incorrect Product Storage | 3 | 1.0 | 1.0 | no signal |
| 169 | Diabetic Ketoacidosis | 5 | 0.9 | 0.9 | no signal |
| 170 | Product Storage Error | 18 | 0.9 | 0.9 | no signal |
| 171 | Pancreatic Carcinoma | 5 | 0.8 | 0.8 | no signal |
| 172 | Breast Cancer | 13 | 0.6 | 0.6 | no signal |
| 173 | Extrapyramidal Disorder | 3 | 0.5 | 0.5 | no signal |
| 174 | Gastric Cancer | 3 | 0.5 | 0.5 | no signal |
| 175 | Oesophageal Carcinoma | 3 | 0.4 | 0.4 | no signal |
| 176 | Device Dislocation | 4 | 0.4 | 0.4 | no signal |
| 177 | Renal Cancer | 3 | 0.3 | 0.3 | no signal |