Drug
Efgartigimod 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 | Eyelid Ptosis | 114 | 61.3 | 63.1 | signal |
| 2 | Therapy Change | 50 | 28.2 | 28.5 | signal |
| 3 | Choking | 97 | 27.1 | 27.8 | signal |
| 4 | Diplopia | 123 | 25.7 | 26.5 | signal |
| 5 | Poor Venous Access | 35 | 18.4 | 18.5 | signal |
| 6 | Therapeutic Response Shortened | 89 | 15.2 | 15.5 | signal |
| 7 | Drug Effect Less Than Expected | 31 | 11.9 | 12.0 | signal |
| 8 | Dysarthria | 82 | 11.8 | 12.0 | signal |
| 9 | Therapy Non-responder | 85 | 10.3 | 10.5 | signal |
| 10 | Dysphagia | 176 | 10.1 | 10.5 | signal |
| 11 | Diverticulitis | 48 | 9.4 | 9.5 | signal |
| 12 | Muscular Weakness | 196 | 9.3 | 9.8 | signal |
| 13 | Therapy Cessation | 88 | 9.3 | 9.5 | signal |
| 14 | Insurance Issue | 24 | 8.7 | 8.8 | signal |
| 15 | Sars-cov-2 Test Positive | 20 | 8.1 | 8.1 | signal |
| 16 | Spinal Operation | 18 | 8.0 | 8.1 | signal |
| 17 | Therapeutic Product Effect Decreased | 65 | 7.9 | 8.0 | signal |
| 18 | Upper Respiratory Tract Infection | 65 | 7.6 | 7.7 | signal |
| 19 | Pulmonary Mass | 20 | 7.3 | 7.3 | signal |
| 20 | Nephrolithiasis | 58 | 6.9 | 6.9 | signal |
| 21 | Therapy Interrupted | 86 | 6.7 | 6.9 | signal |
| 22 | Urinary Tract Infection | 211 | 6.7 | 7.0 | signal |
| 23 | Pharyngeal Swelling | 11 | 6.2 | 6.2 | signal |
| 24 | Hospitalisation | 175 | 6.2 | 6.5 | signal |
| 25 | Respiratory Tract Infection | 29 | 6.0 | 6.1 | signal |
| 26 | Salivary Hypersecretion | 11 | 6.0 | 6.0 | signal |
| 27 | Loss Of Personal Independence In Daily Activities | 52 | 5.9 | 6.0 | signal |
| 28 | Autoimmune Disorder | 10 | 5.7 | 5.7 | signal |
| 29 | Back Injury | 11 | 5.5 | 5.5 | signal |
| 30 | Dyspnoea Exertional | 38 | 5.5 | 5.5 | signal |
| 31 | Covid-19 | 174 | 5.3 | 5.5 | signal |
| 32 | Pulmonary Congestion | 13 | 5.3 | 5.3 | signal |
| 33 | Urosepsis | 9 | 5.3 | 5.3 | signal |
| 34 | Herpes Zoster | 56 | 5.3 | 5.3 | signal |
| 35 | Aspiration | 10 | 5.0 | 5.0 | signal |
| 36 | Bedridden | 12 | 4.9 | 5.0 | signal |
| 37 | Speech Disorder | 47 | 4.9 | 4.9 | signal |
| 38 | Mitral Valve Incompetence | 10 | 4.8 | 4.8 | signal |
| 39 | Pneumonia Aspiration | 22 | 4.8 | 4.8 | signal |
| 40 | Skin Laceration | 9 | 4.5 | 4.5 | signal |
| 41 | Brain Fog | 12 | 4.4 | 4.5 | signal |
| 42 | Rib Fracture | 16 | 4.2 | 4.2 | signal |
| 43 | Seasonal Allergy | 11 | 4.2 | 4.2 | signal |
| 44 | Inappropriate Schedule Of Product Administration | 137 | 4.2 | 4.3 | signal |
| 45 | Drug Effective For Unapproved Indication | 22 | 4.1 | 4.1 | signal |
| 46 | Muscle Twitching | 17 | 4.0 | 4.0 | signal |
| 47 | Therapy Partial Responder | 11 | 3.9 | 4.0 | signal |
| 48 | Knee Operation | 7 | 3.9 | 3.9 | signal |
| 49 | Knee Arthroplasty | 15 | 3.9 | 3.9 | signal |
| 50 | Dysstasia | 21 | 3.9 | 3.9 | signal |
| 51 | Musculoskeletal Chest Pain | 11 | 3.8 | 3.8 | signal |
| 52 | Spinal Fracture | 14 | 3.8 | 3.8 | signal |
| 53 | Respiratory Disorder | 21 | 3.8 | 3.8 | signal |
| 54 | Musculoskeletal Discomfort | 12 | 3.8 | 3.8 | signal |
| 55 | Therapeutic Product Effect Incomplete | 49 | 3.7 | 3.8 | signal |
| 56 | Sepsis | 77 | 3.7 | 3.8 | signal |
| 57 | Asthenia | 259 | 3.7 | 3.9 | signal |
| 58 | Cytokine Release Syndrome | 13 | 3.7 | 3.7 | signal |
| 59 | Immunodeficiency | 10 | 3.7 | 3.7 | signal |
| 60 | Cataract | 40 | 3.6 | 3.7 | signal |
| 61 | Cellulitis | 34 | 3.6 | 3.7 | signal |
| 62 | Covid-19 Pneumonia | 8 | 3.6 | 3.6 | signal |
| 63 | Lacrimation Increased | 20 | 3.6 | 3.6 | signal |
| 64 | Fall | 222 | 3.6 | 3.8 | signal |
| 65 | Device Related Infection | 10 | 3.5 | 3.5 | signal |
| 66 | Secretion Discharge | 8 | 3.5 | 3.5 | signal |
| 67 | Atrial Fibrillation | 62 | 3.4 | 3.5 | signal |
| 68 | Productive Cough | 30 | 3.4 | 3.4 | signal |
| 69 | Dysphonia | 37 | 3.4 | 3.4 | signal |
| 70 | Nerve Injury | 7 | 3.4 | 3.4 | signal |
| 71 | Hypertensive Crisis | 7 | 3.4 | 3.4 | signal |
| 72 | Head Discomfort | 11 | 3.4 | 3.4 | signal |
| 73 | Micturition Urgency | 7 | 3.3 | 3.3 | signal |
| 74 | Kidney Infection | 12 | 3.3 | 3.3 | signal |
| 75 | Internal Haemorrhage | 7 | 3.3 | 3.3 | signal |
| 76 | Joint Injury | 13 | 3.3 | 3.3 | signal |
| 77 | Hip Arthroplasty | 9 | 3.2 | 3.2 | signal |
| 78 | Sluggishness | 6 | 3.2 | 3.2 | signal |
| 79 | Temperature Intolerance | 6 | 3.2 | 3.2 | signal |
| 80 | Weight Fluctuation | 6 | 3.1 | 3.1 | signal |
| 81 | Post Procedural Complication | 11 | 3.1 | 3.1 | signal |
| 82 | Tooth Extraction | 7 | 3.0 | 3.0 | signal |
| 83 | Muscle Tightness | 9 | 3.0 | 3.0 | signal |
| 84 | Blood Pressure Abnormal | 11 | 3.0 | 3.0 | signal |
| 85 | Clostridium Difficile Infection | 12 | 3.0 | 3.0 | signal |
| 86 | Gastroenteritis Viral | 10 | 3.0 | 3.0 | signal |
| 87 | Intentional Dose Omission | 15 | 3.0 | 3.0 | signal |
| 88 | Balance Disorder | 47 | 2.9 | 3.0 | signal |
| 89 | Head Injury | 17 | 2.9 | 2.9 | signal |
| 90 | Tooth Infection | 7 | 2.9 | 2.9 | signal |
| 91 | Complication Associated With Device | 7 | 2.9 | 2.9 | signal |
| 92 | Cholecystectomy | 6 | 2.9 | 2.9 | signal |
| 93 | Dyspnoea | 298 | 2.8 | 3.0 | signal |
| 94 | Eye Disorder | 17 | 2.8 | 2.8 | signal |
| 95 | Eating Disorder | 11 | 2.8 | 2.8 | signal |
| 96 | Abdominal Pain Lower | 13 | 2.8 | 2.8 | signal |
| 97 | Fatigue | 396 | 2.8 | 3.0 | signal |
| 98 | Nasopharyngitis | 94 | 2.8 | 2.8 | signal |
| 99 | Blood Iron Decreased | 6 | 2.8 | 2.8 | signal |
| 100 | Influenza | 56 | 2.7 | 2.7 | signal |
| 101 | Neck Pain | 28 | 2.7 | 2.7 | signal |
| 102 | Therapeutic Response Decreased | 30 | 2.7 | 2.7 | signal |
| 103 | Dry Throat | 5 | 2.7 | 2.7 | no signal |
| 104 | Hypersomnia | 14 | 2.6 | 2.6 | signal |
| 105 | Limb Discomfort | 15 | 2.6 | 2.6 | signal |
| 106 | Petechiae | 5 | 2.6 | 2.6 | no signal |
| 107 | Muscle Atrophy | 6 | 2.6 | 2.6 | signal |
| 108 | Lower Limb Fracture | 9 | 2.5 | 2.6 | signal |
| 109 | Hemiparesis | 8 | 2.5 | 2.5 | signal |
| 110 | Hip Fracture | 15 | 2.5 | 2.5 | signal |
| 111 | Ankle Fracture | 7 | 2.4 | 2.4 | signal |
| 112 | Feeding Disorder | 9 | 2.4 | 2.4 | signal |
| 113 | Basal Cell Carcinoma | 7 | 2.4 | 2.4 | signal |
| 114 | Intestinal Perforation | 5 | 2.4 | 2.4 | no signal |
| 115 | Stress | 32 | 2.4 | 2.4 | signal |
| 116 | Limb Injury | 12 | 2.4 | 2.4 | signal |
| 117 | Retinal Detachment | 4 | 2.4 | 2.4 | no signal |
| 118 | Metastases To Lung | 5 | 2.3 | 2.3 | no signal |
| 119 | Device Occlusion | 6 | 2.3 | 2.3 | no signal |
| 120 | Surgery | 25 | 2.3 | 2.3 | signal |
| 121 | Aphonia | 6 | 2.3 | 2.3 | no signal |
| 122 | Back Disorder | 7 | 2.3 | 2.3 | signal |
| 123 | Post Procedural Haemorrhage | 5 | 2.3 | 2.3 | no signal |
| 124 | Diarrhoea Haemorrhagic | 4 | 2.3 | 2.3 | no signal |
| 125 | Skin Reaction | 6 | 2.3 | 2.3 | no signal |
| 126 | Squamous Cell Carcinoma | 4 | 2.3 | 2.3 | no signal |
| 127 | Infusion Related Reaction | 28 | 2.3 | 2.3 | signal |
| 128 | Illness | 42 | 2.3 | 2.3 | signal |
| 129 | Skin Cancer | 9 | 2.3 | 2.3 | signal |
| 130 | Nasal Congestion | 24 | 2.2 | 2.2 | signal |
| 131 | Hospice Care | 4 | 2.2 | 2.2 | no signal |
| 132 | Eye Discharge | 4 | 2.1 | 2.1 | no signal |
| 133 | Ear Discomfort | 4 | 2.1 | 2.1 | no signal |
| 134 | Anaphylactic Reaction | 21 | 2.1 | 2.1 | signal |
| 135 | Hereditary Angioedema | 4 | 2.1 | 2.1 | no signal |
| 136 | Immune System Disorder | 5 | 2.1 | 2.1 | no signal |
| 137 | Ill-defined Disorder | 23 | 2.0 | 2.1 | signal |
| 138 | Respiratory Tract Congestion | 6 | 2.0 | 2.0 | no signal |
| 139 | Malignant Melanoma | 5 | 2.0 | 2.0 | no signal |
| 140 | Pharyngitis Streptococcal | 4 | 2.0 | 2.0 | no signal |
| 141 | Hernia | 7 | 2.0 | 2.0 | no signal |
| 142 | Throat Irritation | 16 | 1.9 | 1.9 | no signal |
| 143 | Product Availability Issue | 8 | 1.9 | 1.9 | no signal |
| 144 | Systemic Lupus Erythematosus | 12 | 1.8 | 1.8 | no signal |
| 145 | Polyneuropathy | 4 | 1.8 | 1.8 | no signal |
| 146 | Macular Degeneration | 4 | 1.8 | 1.8 | no signal |
| 147 | Thyroid Cancer | 4 | 1.8 | 1.8 | no signal |
| 148 | Neoplasm Malignant | 22 | 1.8 | 1.8 | no signal |
| 149 | Product Dose Omission Issue | 91 | 1.7 | 1.7 | no signal |
| 150 | Intraocular Pressure Increased | 4 | 1.7 | 1.7 | no signal |
| 151 | Adverse Reaction | 4 | 1.6 | 1.6 | no signal |
| 152 | Pneumocystis Jirovecii Pneumonia | 3 | 1.6 | 1.6 | no signal |
| 153 | Metastases To Liver | 5 | 1.5 | 1.5 | no signal |
| 154 | Dialysis | 4 | 1.5 | 1.5 | no signal |
| 155 | Blood Glucose Fluctuation | 3 | 1.5 | 1.5 | no signal |
| 156 | Lung Neoplasm Malignant | 11 | 1.4 | 1.4 | no signal |
| 157 | Pemphigus | 3 | 1.3 | 1.3 | no signal |
| 158 | Cytomegalovirus Infection | 4 | 1.3 | 1.3 | no signal |
| 159 | Prostate Cancer | 19 | 1.3 | 1.3 | no signal |
| 160 | Syringe Issue | 4 | 1.2 | 1.2 | no signal |
| 161 | Breast Cancer Female | 6 | 1.2 | 1.2 | no signal |
| 162 | Blood Glucose Abnormal | 4 | 1.2 | 1.2 | no signal |
| 163 | Osteonecrosis | 7 | 1.1 | 1.1 | no signal |
| 164 | Diabetic Ketoacidosis | 5 | 1.1 | 1.1 | no signal |
| 165 | Injection Site Haematoma | 3 | 1.1 | 1.1 | no signal |
| 166 | Meningioma | 3 | 1.1 | 1.1 | no signal |
| 167 | Glycosylated Haemoglobin Increased | 5 | 1.1 | 1.1 | no signal |
| 168 | Incorrect Product Administration Duration | 4 | 1.1 | 1.1 | no signal |
| 169 | Hepatic Cancer | 4 | 0.9 | 0.9 | no signal |
| 170 | Pancreatic Carcinoma | 4 | 0.7 | 0.7 | no signal |
| 171 | Injection Site Rash | 4 | 0.7 | 0.7 | no signal |
| 172 | Breast Cancer | 12 | 0.7 | 0.7 | no signal |
| 173 | Product Storage Error | 11 | 0.7 | 0.7 | no signal |
| 174 | Bladder Cancer | 7 | 0.6 | 0.6 | no signal |
| 175 | Device Dislocation | 4 | 0.5 | 0.5 | no signal |
| 176 | Renal Cancer | 4 | 0.4 | 0.4 | no signal |