Drug
Icatibant
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 | Hereditary Angioedema | 1,177 | 817.3 | 1,282.4 | signal |
| 2 | Pharyngeal Swelling | 93 | 63.4 | 65.3 | signal |
| 3 | Insurance Issue | 144 | 63.3 | 66.2 | signal |
| 4 | Product Availability Issue | 135 | 39.2 | 40.8 | signal |
| 5 | Body Height Decreased | 46 | 27.6 | 28.0 | signal |
| 6 | Poor Venous Access | 41 | 25.8 | 26.1 | signal |
| 7 | Pregnancy | 73 | 23.4 | 23.9 | signal |
| 8 | Product Prescribing Error | 73 | 20.0 | 20.4 | signal |
| 9 | Weight Fluctuation | 32 | 19.9 | 20.1 | signal |
| 10 | Angioedema | 119 | 17.5 | 18.1 | signal |
| 11 | Stress | 191 | 17.2 | 18.2 | signal |
| 12 | Seasonal Allergy | 37 | 17.0 | 17.2 | signal |
| 13 | Infusion Site Pain | 29 | 14.7 | 14.8 | signal |
| 14 | Ligament Sprain | 22 | 14.4 | 14.5 | signal |
| 15 | Limb Injury | 60 | 14.4 | 14.6 | signal |
| 16 | Treatment Noncompliance | 101 | 12.0 | 12.4 | signal |
| 17 | Expired Product Administered | 58 | 11.3 | 11.5 | signal |
| 18 | Appendicitis | 16 | 11.1 | 11.2 | signal |
| 19 | Skin Laceration | 18 | 10.8 | 10.8 | signal |
| 20 | Product Dose Omission In Error | 38 | 9.2 | 9.3 | signal |
| 21 | Product Use Issue | 261 | 9.0 | 9.7 | signal |
| 22 | Accident | 16 | 8.7 | 8.7 | signal |
| 23 | Weight Increased | 282 | 8.2 | 8.9 | signal |
| 24 | Influenza | 141 | 8.2 | 8.5 | signal |
| 25 | Joint Dislocation | 13 | 8.0 | 8.0 | signal |
| 26 | Inability To Afford Medication | 12 | 7.9 | 7.9 | signal |
| 27 | Pharyngitis | 15 | 7.8 | 7.8 | signal |
| 28 | Product Prescribing Issue | 24 | 7.6 | 7.7 | signal |
| 29 | Gastroenteritis | 17 | 7.5 | 7.6 | signal |
| 30 | Lymphoma | 18 | 7.5 | 7.6 | signal |
| 31 | Inappropriate Schedule Of Product Administration | 201 | 7.4 | 7.8 | signal |
| 32 | Needle Issue | 32 | 7.2 | 7.3 | signal |
| 33 | Illness | 108 | 7.0 | 7.2 | signal |
| 34 | Toothache | 19 | 6.8 | 6.8 | signal |
| 35 | Gastroenteritis Viral | 19 | 6.8 | 6.8 | signal |
| 36 | Post Procedural Complication | 20 | 6.7 | 6.8 | signal |
| 37 | Product Dose Omission Issue | 295 | 6.7 | 7.3 | signal |
| 38 | Covid-19 | 179 | 6.5 | 6.9 | signal |
| 39 | Ovarian Cyst | 10 | 6.4 | 6.5 | signal |
| 40 | Complication Associated With Device | 13 | 6.4 | 6.4 | signal |
| 41 | Weight Decreased | 274 | 6.4 | 6.8 | signal |
| 42 | Procedural Pain | 26 | 6.1 | 6.1 | signal |
| 43 | Joint Injury | 20 | 6.1 | 6.1 | signal |
| 44 | Gastritis | 24 | 5.9 | 5.9 | signal |
| 45 | Tooth Infection | 12 | 5.9 | 5.9 | signal |
| 46 | Upper Limb Fracture | 18 | 5.8 | 5.8 | signal |
| 47 | Nephrolithiasis | 40 | 5.7 | 5.7 | signal |
| 48 | Depressed Mood | 46 | 5.7 | 5.7 | signal |
| 49 | Brain Oedema | 11 | 5.6 | 5.7 | signal |
| 50 | Scratch | 9 | 5.6 | 5.6 | signal |
| 51 | Injection Site Urticaria | 21 | 5.6 | 5.6 | signal |
| 52 | Aphonia | 12 | 5.6 | 5.6 | signal |
| 53 | Crying | 31 | 5.5 | 5.5 | signal |
| 54 | Dysmenorrhoea | 11 | 5.4 | 5.5 | signal |
| 55 | Nasal Congestion | 49 | 5.4 | 5.5 | signal |
| 56 | Hernia | 16 | 5.4 | 5.4 | signal |
| 57 | Ear Infection | 22 | 5.4 | 5.4 | signal |
| 58 | Intentional Product Use Issue | 72 | 5.3 | 5.4 | signal |
| 59 | Injection Site Bruising | 62 | 5.1 | 5.2 | signal |
| 60 | Drug Effect Less Than Expected | 11 | 5.0 | 5.1 | signal |
| 61 | Kidney Infection | 15 | 4.9 | 5.0 | signal |
| 62 | Road Traffic Accident | 32 | 4.9 | 5.0 | signal |
| 63 | Tooth Disorder | 17 | 4.9 | 4.9 | signal |
| 64 | Inflammation | 38 | 4.8 | 4.8 | signal |
| 65 | Injection Site Swelling | 55 | 4.7 | 4.8 | signal |
| 66 | Fear | 19 | 4.5 | 4.6 | signal |
| 67 | Poor Quality Sleep | 15 | 4.5 | 4.6 | signal |
| 68 | Head Injury | 22 | 4.5 | 4.5 | signal |
| 69 | Viral Infection | 23 | 4.5 | 4.5 | signal |
| 70 | Tooth Abscess | 7 | 4.4 | 4.4 | signal |
| 71 | Syringe Issue | 12 | 4.4 | 4.4 | signal |
| 72 | Application Site Pain | 15 | 4.4 | 4.4 | signal |
| 73 | Injection Site Discomfort | 7 | 4.4 | 4.4 | signal |
| 74 | Injection Site Pain | 205 | 4.4 | 4.6 | signal |
| 75 | Covid-19 Pneumonia | 8 | 4.4 | 4.4 | signal |
| 76 | Injection Site Erythema | 83 | 4.3 | 4.4 | signal |
| 77 | Ear Pain | 13 | 4.3 | 4.3 | signal |
| 78 | Device Related Infection | 10 | 4.2 | 4.2 | signal |
| 79 | Musculoskeletal Chest Pain | 10 | 4.2 | 4.2 | signal |
| 80 | Product Use Complaint | 10 | 4.2 | 4.2 | signal |
| 81 | Swollen Tongue | 20 | 4.1 | 4.2 | signal |
| 82 | Gastrointestinal Pain | 7 | 4.1 | 4.1 | signal |
| 83 | Tooth Fracture | 7 | 4.1 | 4.1 | signal |
| 84 | Dental Caries | 7 | 4.1 | 4.1 | signal |
| 85 | Respiratory Disorder | 19 | 4.1 | 4.1 | signal |
| 86 | Injection Site Irritation | 8 | 4.1 | 4.1 | signal |
| 87 | Sciatica | 10 | 4.1 | 4.1 | signal |
| 88 | Discomfort | 38 | 4.1 | 4.1 | signal |
| 89 | Cystitis | 20 | 4.0 | 4.1 | signal |
| 90 | Abdominal Distension | 65 | 4.0 | 4.1 | signal |
| 91 | Neuralgia | 15 | 4.0 | 4.0 | signal |
| 92 | Injection Site Induration | 8 | 4.0 | 4.0 | signal |
| 93 | Brain Fog | 9 | 4.0 | 4.0 | signal |
| 94 | Dermatitis Contact | 7 | 4.0 | 4.0 | signal |
| 95 | Intestinal Obstruction | 23 | 4.0 | 4.0 | signal |
| 96 | Gastrointestinal Disorder | 54 | 4.0 | 4.0 | signal |
| 97 | Bedridden | 8 | 3.9 | 3.9 | signal |
| 98 | Neoplasm | 7 | 3.9 | 3.9 | signal |
| 99 | Blood Pressure Abnormal | 12 | 3.9 | 3.9 | signal |
| 100 | Salivary Hypersecretion | 6 | 3.9 | 3.9 | signal |
| 101 | Splenomegaly | 7 | 3.9 | 3.9 | signal |
| 102 | Injection Site Reaction | 41 | 3.9 | 3.9 | signal |
| 103 | Intervertebral Disc Protrusion | 13 | 3.8 | 3.8 | signal |
| 104 | Tendonitis | 9 | 3.7 | 3.8 | signal |
| 105 | Foot Fracture | 11 | 3.7 | 3.8 | signal |
| 106 | Cataract | 34 | 3.7 | 3.7 | signal |
| 107 | Injection Site Pruritus | 38 | 3.7 | 3.7 | signal |
| 108 | Mass | 8 | 3.7 | 3.7 | signal |
| 109 | Renal Pain | 6 | 3.7 | 3.7 | signal |
| 110 | Swelling | 53 | 3.7 | 3.7 | signal |
| 111 | Mental Disorder | 24 | 3.6 | 3.6 | signal |
| 112 | Cholelithiasis | 18 | 3.5 | 3.6 | signal |
| 113 | Eye Infection | 6 | 3.5 | 3.5 | signal |
| 114 | Injection Site Rash | 16 | 3.4 | 3.4 | signal |
| 115 | Musculoskeletal Discomfort | 9 | 3.4 | 3.4 | signal |
| 116 | Influenza Like Illness | 43 | 3.4 | 3.4 | signal |
| 117 | Eating Disorder | 11 | 3.3 | 3.3 | signal |
| 118 | Head Discomfort | 9 | 3.3 | 3.3 | signal |
| 119 | Skin Cancer | 11 | 3.3 | 3.3 | signal |
| 120 | Migraine | 48 | 3.3 | 3.3 | signal |
| 121 | Sinus Disorder | 10 | 3.3 | 3.3 | signal |
| 122 | Wrist Fracture | 6 | 3.2 | 3.2 | signal |
| 123 | Burning Sensation | 35 | 3.2 | 3.3 | signal |
| 124 | Carpal Tunnel Syndrome | 7 | 3.2 | 3.2 | signal |
| 125 | Brain Injury | 5 | 3.2 | 3.2 | signal |
| 126 | Dysphonia | 29 | 3.2 | 3.2 | signal |
| 127 | Sinusitis | 51 | 3.2 | 3.2 | signal |
| 128 | Fibromyalgia | 12 | 3.2 | 3.2 | signal |
| 129 | Malaise | 217 | 3.2 | 3.4 | signal |
| 130 | Temperature Intolerance | 5 | 3.2 | 3.2 | signal |
| 131 | Poor Quality Product Administered | 5 | 3.2 | 3.2 | signal |
| 132 | Oropharyngeal Pain | 45 | 3.1 | 3.2 | signal |
| 133 | Tendon Rupture | 6 | 3.1 | 3.1 | signal |
| 134 | Injection Site Discolouration | 6 | 3.1 | 3.1 | signal |
| 135 | Blood Urine Present | 9 | 3.1 | 3.1 | signal |
| 136 | Diverticulitis | 13 | 3.0 | 3.1 | signal |
| 137 | Scar | 8 | 3.0 | 3.0 | signal |
| 138 | Haematoma | 12 | 3.0 | 3.0 | signal |
| 139 | Pulmonary Thrombosis | 5 | 3.0 | 3.0 | signal |
| 140 | Immune System Disorder | 6 | 2.9 | 3.0 | signal |
| 141 | Limb Discomfort | 14 | 2.9 | 2.9 | signal |
| 142 | Feeding Disorder | 9 | 2.9 | 2.9 | signal |
| 143 | Eye Haemorrhage | 6 | 2.9 | 2.9 | signal |
| 144 | Obstructive Airways Disorder | 5 | 2.9 | 2.9 | signal |
| 145 | Gallbladder Disorder | 8 | 2.9 | 2.9 | signal |
| 146 | Adverse Event | 41 | 2.9 | 2.9 | signal |
| 147 | Cholecystectomy | 5 | 2.8 | 2.8 | signal |
| 148 | Speech Disorder | 23 | 2.8 | 2.9 | signal |
| 149 | Anaphylactic Reaction | 24 | 2.8 | 2.8 | signal |
| 150 | Brain Neoplasm | 4 | 2.8 | 2.8 | no signal |
| 151 | Hospitalisation | 66 | 2.8 | 2.8 | signal |
| 152 | Nasopharyngitis | 80 | 2.8 | 2.8 | signal |
| 153 | Back Disorder | 7 | 2.8 | 2.8 | signal |
| 154 | Post Procedural Haemorrhage | 5 | 2.8 | 2.8 | signal |
| 155 | Diarrhoea Haemorrhagic | 4 | 2.8 | 2.8 | no signal |
| 156 | Injury | 30 | 2.7 | 2.8 | signal |
| 157 | Systemic Lupus Erythematosus | 15 | 2.7 | 2.8 | signal |
| 158 | Urticaria | 70 | 2.7 | 2.8 | signal |
| 159 | Emotional Disorder | 13 | 2.7 | 2.7 | signal |
| 160 | Nervousness | 22 | 2.7 | 2.7 | signal |
| 161 | Lower Limb Fracture | 8 | 2.7 | 2.7 | signal |
| 162 | Anosmia | 6 | 2.7 | 2.7 | signal |
| 163 | Localised Infection | 10 | 2.7 | 2.7 | signal |
| 164 | Face Oedema | 7 | 2.7 | 2.7 | signal |
| 165 | No Adverse Event | 72 | 2.6 | 2.7 | signal |
| 166 | Mood Altered | 11 | 2.6 | 2.6 | signal |
| 167 | Exposure During Pregnancy | 25 | 2.6 | 2.6 | signal |
| 168 | Throat Irritation | 17 | 2.5 | 2.5 | signal |
| 169 | Breast Pain | 4 | 2.4 | 2.4 | no signal |
| 170 | Product Packaging Quantity Issue | 4 | 2.4 | 2.4 | no signal |
| 171 | Cardiac Disorder | 34 | 2.3 | 2.4 | signal |
| 172 | Lip Swelling | 12 | 2.3 | 2.3 | signal |
| 173 | Oral Discomfort | 5 | 2.3 | 2.3 | no signal |
| 174 | Spinal Fracture | 7 | 2.3 | 2.3 | no signal |
| 175 | Internal Haemorrhage | 4 | 2.3 | 2.3 | no signal |
| 176 | Abortion Spontaneous | 14 | 2.3 | 2.3 | signal |
| 177 | Incorrect Product Administration Duration | 7 | 2.2 | 2.2 | no signal |
| 178 | Injection Site Warmth | 7 | 2.2 | 2.2 | no signal |
| 179 | Intentional Dose Omission | 9 | 2.1 | 2.1 | signal |
| 180 | Pharyngeal Oedema | 5 | 2.1 | 2.1 | no signal |
| 181 | Therapy Interrupted | 22 | 2.1 | 2.1 | signal |
| 182 | Leukaemia | 3 | 2.1 | 2.1 | no signal |
| 183 | Eye Inflammation | 3 | 2.1 | 2.1 | no signal |
| 184 | Maternal Exposure During Pregnancy | 28 | 2.1 | 2.1 | signal |
| 185 | Eructation | 6 | 2.0 | 2.0 | no signal |
| 186 | Abdominal Pain Lower | 8 | 2.0 | 2.0 | no signal |
| 187 | Affect Lability | 3 | 2.0 | 2.0 | no signal |
| 188 | Decreased Immune Responsiveness | 3 | 2.0 | 2.0 | no signal |
| 189 | Injection Site Mass | 11 | 1.9 | 1.9 | no signal |
| 190 | Injury Associated With Device | 6 | 1.9 | 1.9 | no signal |
| 191 | Circumstance Or Information Capable Of Leading To Medication Error | 10 | 1.9 | 1.9 | no signal |
| 192 | Helicobacter Infection | 3 | 1.9 | 1.9 | no signal |
| 193 | Menstruation Delayed | 3 | 1.9 | 1.9 | no signal |
| 194 | Neoplasm Malignant | 19 | 1.8 | 1.8 | no signal |
| 195 | Product Storage Error | 23 | 1.7 | 1.7 | no signal |
| 196 | Application Site Erythema | 6 | 1.5 | 1.5 | no signal |
| 197 | Application Site Rash | 3 | 1.4 | 1.4 | no signal |
| 198 | Vaginal Haemorrhage | 9 | 1.4 | 1.4 | no signal |
| 199 | Acne | 16 | 1.4 | 1.4 | no signal |
| 200 | Injection Site Haemorrhage | 16 | 1.3 | 1.3 | no signal |
| 201 | Gastric Cancer | 5 | 1.3 | 1.3 | no signal |
| 202 | Menstruation Irregular | 5 | 1.2 | 1.2 | no signal |
| 203 | Device Issue | 16 | 1.2 | 1.2 | no signal |
| 204 | Product Administered At Inappropriate Site | 3 | 1.1 | 1.1 | no signal |
| 205 | Breast Cancer | 14 | 1.0 | 1.0 | no signal |
| 206 | Breast Cancer Female | 3 | 0.7 | 0.7 | no signal |
| 207 | Device Difficult To Use | 7 | 0.7 | 0.7 | no signal |
| 208 | Prostate Cancer | 8 | 0.6 | 0.6 | no signal |
| 209 | Wrong Technique In Device Usage Process | 3 | 0.4 | 0.4 | no signal |
| 210 | Renal Cancer | 3 | 0.4 | 0.4 | no signal |