Drug
Adalimumab-afzb
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 | Device Mechanical Issue | 117 | 73.5 | 76.9 | signal |
| 2 | Uveitis | 77 | 46.0 | 47.4 | signal |
| 3 | Fistula | 64 | 45.9 | 47.0 | signal |
| 4 | Abscess | 67 | 33.9 | 34.7 | signal |
| 5 | Drug Level Decreased | 37 | 29.2 | 29.6 | signal |
| 6 | Device Defective | 52 | 25.9 | 26.4 | signal |
| 7 | Therapeutic Response Shortened | 79 | 20.0 | 20.6 | signal |
| 8 | Condition Aggravated | 626 | 16.7 | 21.6 | signal |
| 9 | Needle Issue | 58 | 16.3 | 16.7 | signal |
| 10 | Exposure Via Skin Contact | 44 | 15.7 | 15.9 | signal |
| 11 | Device Leakage | 79 | 15.0 | 15.4 | signal |
| 12 | Drug Dose Omission By Device | 142 | 14.9 | 15.7 | signal |
| 13 | Therapeutic Product Effect Incomplete | 114 | 13.0 | 13.5 | signal |
| 14 | Blood Iron Decreased | 19 | 13.0 | 13.0 | signal |
| 15 | Intestinal Obstruction | 59 | 12.7 | 12.9 | signal |
| 16 | Haematochezia | 80 | 11.7 | 12.0 | signal |
| 17 | Device Failure | 22 | 11.7 | 11.8 | signal |
| 18 | Incorrect Dose Administered By Device | 36 | 11.4 | 11.5 | signal |
| 19 | Ankylosing Spondylitis | 17 | 10.5 | 10.6 | signal |
| 20 | Injection Site Discomfort | 13 | 10.1 | 10.2 | signal |
| 21 | Device Deployment Issue | 15 | 10.0 | 10.1 | signal |
| 22 | Hernia | 24 | 10.0 | 10.1 | signal |
| 23 | Mouth Ulceration | 26 | 9.9 | 10.0 | signal |
| 24 | Device Delivery System Issue | 32 | 9.8 | 10.0 | signal |
| 25 | Eye Infection | 13 | 9.3 | 9.4 | signal |
| 26 | Frequent Bowel Movements | 31 | 9.3 | 9.4 | signal |
| 27 | Cyst | 14 | 9.1 | 9.1 | signal |
| 28 | Haemorrhoids | 22 | 9.0 | 9.1 | signal |
| 29 | Pharyngitis | 14 | 9.0 | 9.1 | signal |
| 30 | Synovitis | 20 | 8.9 | 9.0 | signal |
| 31 | Skin Infection | 12 | 8.6 | 8.7 | signal |
| 32 | Nodule | 14 | 8.6 | 8.7 | signal |
| 33 | Hip Arthroplasty | 16 | 8.5 | 8.5 | signal |
| 34 | Rectal Haemorrhage | 45 | 8.4 | 8.5 | signal |
| 35 | Device Use Issue | 17 | 7.9 | 7.9 | signal |
| 36 | Off Label Use | 832 | 7.7 | 10.8 | signal |
| 37 | Joint Injury | 20 | 7.5 | 7.6 | signal |
| 38 | Knee Operation | 9 | 7.4 | 7.5 | signal |
| 39 | Skin Laceration | 10 | 7.4 | 7.5 | signal |
| 40 | Pharyngitis Streptococcal | 10 | 7.4 | 7.4 | signal |
| 41 | Limb Injury | 25 | 7.4 | 7.5 | signal |
| 42 | Clostridium Difficile Infection | 20 | 7.4 | 7.5 | signal |
| 43 | Knee Arthroplasty | 19 | 7.3 | 7.4 | signal |
| 44 | C-reactive Protein Increased | 33 | 7.3 | 7.4 | signal |
| 45 | Feeding Disorder | 18 | 7.3 | 7.3 | signal |
| 46 | Colitis Ulcerative | 40 | 7.2 | 7.3 | signal |
| 47 | Foot Fracture | 17 | 7.2 | 7.2 | signal |
| 48 | Device Occlusion | 12 | 6.9 | 7.0 | signal |
| 49 | Drug Effect Less Than Expected | 12 | 6.8 | 6.9 | signal |
| 50 | Eye Inflammation | 8 | 6.8 | 6.8 | signal |
| 51 | Loss Of Personal Independence In Daily Activities | 40 | 6.8 | 6.8 | signal |
| 52 | Tooth Infection | 11 | 6.7 | 6.7 | signal |
| 53 | Device Difficult To Use | 54 | 6.6 | 6.7 | signal |
| 54 | Inflammatory Bowel Disease | 8 | 6.5 | 6.6 | signal |
| 55 | Poor Quality Sleep | 17 | 6.4 | 6.4 | signal |
| 56 | Cholecystectomy | 9 | 6.4 | 6.4 | signal |
| 57 | Illness | 79 | 6.3 | 6.5 | signal |
| 58 | Carpal Tunnel Syndrome | 11 | 6.3 | 6.3 | signal |
| 59 | Stress | 56 | 6.3 | 6.4 | signal |
| 60 | Weight Fluctuation | 8 | 6.2 | 6.2 | signal |
| 61 | Nephrolithiasis | 35 | 6.1 | 6.2 | signal |
| 62 | Iron Deficiency Anaemia | 7 | 6.1 | 6.1 | signal |
| 63 | Immune System Disorder | 10 | 6.1 | 6.1 | signal |
| 64 | Product Dose Omission In Error | 20 | 6.0 | 6.0 | signal |
| 65 | Viral Infection | 24 | 5.8 | 5.8 | signal |
| 66 | Aphonia | 10 | 5.8 | 5.8 | signal |
| 67 | Body Temperature Decreased | 7 | 5.7 | 5.7 | signal |
| 68 | Inappropriate Schedule Of Product Administration | 124 | 5.6 | 5.9 | signal |
| 69 | Injury Associated With Device | 14 | 5.6 | 5.6 | signal |
| 70 | Hepatic Cirrhosis | 13 | 5.6 | 5.6 | signal |
| 71 | Immunodeficiency | 10 | 5.5 | 5.5 | signal |
| 72 | Scratch | 7 | 5.4 | 5.4 | signal |
| 73 | Device Malfunction | 45 | 5.4 | 5.5 | signal |
| 74 | Wrist Fracture | 8 | 5.4 | 5.4 | signal |
| 75 | Blood Pressure Systolic Increased | 13 | 5.3 | 5.4 | signal |
| 76 | Bursitis | 8 | 5.3 | 5.3 | signal |
| 77 | Inflammation | 34 | 5.3 | 5.4 | signal |
| 78 | Intentional Dose Omission | 18 | 5.3 | 5.3 | signal |
| 79 | Spinal Fracture | 13 | 5.2 | 5.3 | signal |
| 80 | Ankle Fracture | 10 | 5.2 | 5.2 | signal |
| 81 | Tooth Extraction | 8 | 5.2 | 5.2 | signal |
| 82 | Sputum Discoloured | 6 | 5.1 | 5.1 | signal |
| 83 | Wrong Technique In Device Usage Process | 29 | 5.1 | 5.1 | signal |
| 84 | Red Blood Cell Sedimentation Rate Increased | 7 | 5.1 | 5.1 | signal |
| 85 | Post Procedural Complication | 12 | 5.0 | 5.0 | signal |
| 86 | Eating Disorder | 13 | 4.9 | 4.9 | signal |
| 87 | Oropharyngeal Pain | 56 | 4.9 | 4.9 | signal |
| 88 | Covid-19 | 107 | 4.9 | 5.0 | signal |
| 89 | Flatulence | 34 | 4.8 | 4.9 | signal |
| 90 | Ear Discomfort | 6 | 4.7 | 4.7 | signal |
| 91 | Rib Fracture | 12 | 4.7 | 4.7 | signal |
| 92 | Nasal Congestion | 34 | 4.7 | 4.7 | signal |
| 93 | Abdominal Pain | 135 | 4.7 | 4.9 | signal |
| 94 | Tendonitis | 9 | 4.6 | 4.7 | signal |
| 95 | Spinal Operation | 7 | 4.6 | 4.7 | signal |
| 96 | Small Intestinal Obstruction | 7 | 4.6 | 4.6 | signal |
| 97 | Head Discomfort | 10 | 4.6 | 4.6 | signal |
| 98 | Ear Infection | 15 | 4.5 | 4.6 | signal |
| 99 | Injection Site Pain | 169 | 4.5 | 4.7 | signal |
| 100 | Impaired Quality Of Life | 8 | 4.5 | 4.5 | signal |
| 101 | Injection Site Irritation | 7 | 4.4 | 4.5 | signal |
| 102 | Nasopharyngitis | 102 | 4.4 | 4.6 | signal |
| 103 | Wound Infection | 6 | 4.4 | 4.4 | signal |
| 104 | Mental Disorder | 24 | 4.4 | 4.5 | signal |
| 105 | Gastroenteritis | 8 | 4.4 | 4.4 | signal |
| 106 | Abdominal Distension | 57 | 4.4 | 4.5 | signal |
| 107 | Arthralgia | 225 | 4.4 | 4.7 | signal |
| 108 | Localised Infection | 13 | 4.3 | 4.3 | signal |
| 109 | Influenza | 60 | 4.3 | 4.4 | signal |
| 110 | Arthritis | 42 | 4.3 | 4.3 | signal |
| 111 | Colitis | 20 | 4.3 | 4.3 | signal |
| 112 | Musculoskeletal Discomfort | 9 | 4.2 | 4.2 | signal |
| 113 | Malignant Melanoma | 7 | 4.2 | 4.2 | signal |
| 114 | Kidney Infection | 10 | 4.1 | 4.1 | signal |
| 115 | Cataract | 30 | 4.1 | 4.1 | signal |
| 116 | Disease Recurrence | 24 | 4.0 | 4.1 | signal |
| 117 | Gallbladder Disorder | 9 | 4.0 | 4.0 | signal |
| 118 | Mass | 7 | 4.0 | 4.0 | signal |
| 119 | Toothache | 9 | 4.0 | 4.0 | signal |
| 120 | Neoplasm Malignant | 33 | 4.0 | 4.0 | signal |
| 121 | Tooth Abscess | 5 | 3.9 | 3.9 | signal |
| 122 | Skin Disorder | 16 | 3.9 | 3.9 | signal |
| 123 | Blood Urine Present | 9 | 3.8 | 3.8 | signal |
| 124 | Injection Site Bruising | 37 | 3.8 | 3.8 | signal |
| 125 | Rotator Cuff Syndrome | 6 | 3.7 | 3.7 | signal |
| 126 | Pain In Jaw | 13 | 3.7 | 3.7 | signal |
| 127 | Device Breakage | 18 | 3.7 | 3.7 | signal |
| 128 | Sinus Disorder | 9 | 3.6 | 3.7 | signal |
| 129 | Foot Deformity | 5 | 3.6 | 3.6 | signal |
| 130 | Nerve Injury | 5 | 3.6 | 3.6 | signal |
| 131 | Dysstasia | 13 | 3.6 | 3.6 | signal |
| 132 | Conjunctivitis | 8 | 3.5 | 3.5 | signal |
| 133 | Injection Site Mass | 16 | 3.5 | 3.5 | signal |
| 134 | Accidental Exposure To Product | 43 | 3.5 | 3.5 | signal |
| 135 | Appendicitis | 4 | 3.5 | 3.5 | signal |
| 136 | Vasculitis | 5 | 3.4 | 3.4 | signal |
| 137 | Blood Test Abnormal | 6 | 3.4 | 3.4 | signal |
| 138 | Diarrhoea Haemorrhagic | 4 | 3.4 | 3.4 | signal |
| 139 | Treatment Failure | 35 | 3.4 | 3.5 | signal |
| 140 | Squamous Cell Carcinoma | 4 | 3.4 | 3.4 | signal |
| 141 | Accident | 5 | 3.4 | 3.4 | signal |
| 142 | Autoimmune Disorder | 4 | 3.4 | 3.4 | signal |
| 143 | Oral Herpes | 8 | 3.3 | 3.3 | signal |
| 144 | Injection Site Pruritus | 27 | 3.3 | 3.3 | signal |
| 145 | Secretion Discharge | 5 | 3.3 | 3.3 | signal |
| 146 | Tooth Disorder | 9 | 3.2 | 3.2 | signal |
| 147 | Device Issue | 35 | 3.2 | 3.3 | signal |
| 148 | Diverticulitis | 11 | 3.2 | 3.2 | signal |
| 149 | Psoriatic Arthropathy | 16 | 3.2 | 3.2 | signal |
| 150 | Ovarian Cyst | 4 | 3.2 | 3.2 | signal |
| 151 | Injection Site Warmth | 8 | 3.1 | 3.1 | signal |
| 152 | Rheumatoid Arthritis | 43 | 3.1 | 3.1 | signal |
| 153 | Hip Fracture | 12 | 3.0 | 3.0 | signal |
| 154 | Skin Fissures | 7 | 3.0 | 3.0 | signal |
| 155 | Systemic Lupus Erythematosus | 13 | 3.0 | 3.0 | signal |
| 156 | Gingival Bleeding | 5 | 2.9 | 2.9 | signal |
| 157 | Injection Site Haemorrhage | 29 | 2.9 | 3.0 | signal |
| 158 | Gastrointestinal Pain | 4 | 2.9 | 2.9 | no signal |
| 159 | Injection Site Rash | 11 | 2.9 | 2.9 | signal |
| 160 | Intestinal Perforation | 4 | 2.9 | 2.9 | no signal |
| 161 | Acne | 27 | 2.8 | 2.9 | signal |
| 162 | Intentional Product Misuse | 30 | 2.8 | 2.8 | signal |
| 163 | Injection Site Erythema | 42 | 2.7 | 2.8 | signal |
| 164 | Thyroid Cancer | 4 | 2.7 | 2.7 | no signal |
| 165 | Brain Neoplasm | 3 | 2.6 | 2.6 | no signal |
| 166 | Increased Tendency To Bruise | 3 | 2.6 | 2.6 | no signal |
| 167 | Thyroid Disorder | 5 | 2.6 | 2.6 | no signal |
| 168 | Lymphoma | 5 | 2.6 | 2.6 | no signal |
| 169 | Therapeutic Product Effect Decreased | 14 | 2.5 | 2.5 | signal |
| 170 | Injection Site Induration | 4 | 2.5 | 2.5 | no signal |
| 171 | Decreased Immune Responsiveness | 3 | 2.5 | 2.5 | no signal |
| 172 | Dysmenorrhoea | 4 | 2.5 | 2.5 | no signal |
| 173 | Pericarditis | 5 | 2.4 | 2.4 | no signal |
| 174 | Eye Haemorrhage | 4 | 2.4 | 2.4 | no signal |
| 175 | Psoriasis | 39 | 2.4 | 2.4 | signal |
| 176 | Device Use Error | 10 | 2.4 | 2.4 | signal |
| 177 | Poor Venous Access | 3 | 2.3 | 2.3 | no signal |
| 178 | Influenza Like Illness | 24 | 2.3 | 2.3 | signal |
| 179 | Injection Site Swelling | 22 | 2.3 | 2.3 | signal |
| 180 | Procedural Pain | 8 | 2.3 | 2.3 | signal |
| 181 | Therapeutic Response Unexpected | 13 | 2.3 | 2.3 | signal |
| 182 | Syringe Issue | 5 | 2.3 | 2.3 | no signal |
| 183 | Bipolar Disorder | 3 | 2.2 | 2.2 | no signal |
| 184 | Tendon Rupture | 3 | 1.9 | 1.9 | no signal |
| 185 | Injection Site Extravasation | 3 | 1.9 | 1.9 | no signal |
| 186 | Intraocular Pressure Increased | 3 | 1.9 | 1.9 | no signal |
| 187 | Tuberculosis | 3 | 1.9 | 1.9 | no signal |
| 188 | Product Administered At Inappropriate Site | 4 | 1.8 | 1.8 | no signal |
| 189 | Lung Neoplasm Malignant | 9 | 1.7 | 1.8 | no signal |
| 190 | Abortion Spontaneous | 8 | 1.6 | 1.6 | no signal |
| 191 | Product Dispensing Error | 4 | 1.5 | 1.5 | no signal |
| 192 | Skin Irritation | 8 | 1.4 | 1.4 | no signal |
| 193 | Drug Effective For Unapproved Indication | 5 | 1.4 | 1.4 | no signal |
| 194 | Injection Site Urticaria | 4 | 1.3 | 1.3 | no signal |
| 195 | Pancreatic Carcinoma | 4 | 1.1 | 1.1 | no signal |
| 196 | Circumstance Or Information Capable Of Leading To Medication Error | 4 | 1.0 | 1.0 | no signal |
| 197 | Breast Cancer | 8 | 0.7 | 0.7 | no signal |
| 198 | Prostate Cancer | 6 | 0.6 | 0.6 | no signal |
| 199 | Bladder Cancer | 3 | 0.4 | 0.4 | no signal |