TRIAL RESULTS · SIDE EFFECTS
Icatibant side effects
ANSWER
In 4 placebo-controlled trials with posted results, the most common side effects of Icatibant were hereditary angioedema 18.1% (placebo 18.7%), headache 10.1% (placebo 6.7%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
8
with an arm on Icatibant, of 37 registered
Against placebo
4
placebo-controlled trials
People in those trials
330
on Icatibant · 200 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Icatibant beside placebo
Share of people with each side effect in 4 placebo-controlled trials with posted results: 330 people on Icatibant (all doses), 200 on placebo, same trials. Listed only when reported for at least half of the people on Icatibant. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
All 73 side effects reported
Every trial with posted results and an arm on Icatibant (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Icatibant | Placebo | Trials |
|---|---|---|---|---|
| Hereditary Angioedema | Congenital, familial and genetic disorders | 25.0% (45 of 180) | - | 2 |
| Hereditary angioedema | Congenital, familial and genetic disorders | 18.1% (37 of 204) | 18.7% | 2 |
| Headache | Nervous system disorders | 6.5% (24 of 368) | 6.7% | 4 |
| Infections | Infections and infestations | 31.6% (24 of 76) | 13.8% | 1 |
| Administration site conditions | General disorders | 18.4% (14 of 76) | 13.8% | 1 |
| Angioedema | Skin and subcutaneous tissue disorders | 11.7% (7 of 60) | 3.4% | 1 |
| Injection site pain | General disorders | 4.5% (7 of 155) | - | 1 |
| Nasopharyngitis | Infections and infestations | 7.5% (6 of 80) | - | 1 |
| Urinary Track Infection | Infections and infestations | 7.5% (6 of 80) | - | 1 |
| Injury, poisoning and procedual complications | Injury, poisoning and procedural complications | 7.5% (6 of 80) | - | 1 |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | 6.3% (5 of 80) | - | 1 |
| Upper Respiratory Tract Infection | Infections and infestations | 3.9% (5 of 128) | 0.0% | 1 |
| Dizziness | Investigations | 1.3% (3 of 234) | 3.4% | 3 |
| Nausea | Gastrointestinal disorders | 1.4% (3 of 214) | 6.9% | 3 |
| Gastroenteritis | Infections and infestations | 1.4% (3 of 208) | 2.2% | 2 |
| Contusion | Injury, poisoning and procedural complications | 3.9% (3 of 76) | 0.0% | 1 |
| Injection Site Reaction | General disorders | 3.8% (3 of 80) | - | 1 |
| Pharyngitis | Infections and infestations | 3.8% (3 of 80) | - | 1 |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 5.0% (3 of 60) | 3.4% | 1 |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 2.6% (2 of 76) | 0.0% | 1 |
| Blood Creatine Phosphokinase Increased | Investigations | 2.6% (2 of 76) | 0.0% | 1 |
| intravenous catheter issue | Vascular disorders | 3.0% (2 of 66) | 4.5% | 1 |
| HAE attack | Congenital, familial and genetic disorders | 1.3% (1 of 76) | 0.0% | 1 |
| Pancreatitis | Gastrointestinal disorders | 1.3% (1 of 76) | 0.0% | 1 |
| Chest Pain | General disorders | 1.3% (1 of 76) | 0.0% | 1 |
| Respiratory Track Infection | Infections and infestations | 1.3% (1 of 80) | - | 1 |
| Blood and Lymphatic system disorders | Blood and lymphatic system disorders | 1.3% (1 of 80) | - | 1 |
| Cholelithiasis | Hepatobiliary disorders | 1.3% (1 of 80) | - | 1 |
| Cystitis | Infections and infestations | 1.3% (1 of 80) | - | 1 |
| Hypertensive Crisis | Vascular disorders | 1.3% (1 of 80) | - | 1 |
| Coronary Artery Disease | Cardiac disorders | 1.3% (1 of 80) | - | 1 |
| Head Injury | Injury, poisoning and procedural complications | 1.3% (1 of 80) | - | 1 |
| Road Traffic Accident | Injury, poisoning and procedural complications | 1.3% (1 of 80) | - | 1 |
| Wound | Injury, poisoning and procedural complications | 1.3% (1 of 80) | - | 1 |
| Pancreatic Enzymes Increased | Investigations | 1.3% (1 of 80) | - | 1 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1.3% (1 of 80) | - | 1 |
| Cervix Carcinoma Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1.3% (1 of 80) | - | 1 |
| Suicide Attempt | Psychiatric disorders | 1.3% (1 of 80) | - | 1 |
| Renal Failure | Renal and urinary disorders | 1.3% (1 of 80) | - | 1 |
| Tooth Extraction | Surgical and medical procedures | 1.3% (1 of 80) | - | 1 |
| Urinary Track Infection Bacterial | Infections and infestations | 1.3% (1 of 80) | - | 1 |
| Arrhythmia | Cardiac disorders | 0.8% (1 of 128) | 0.0% | 1 |
| Non-Cardiac Chest Pain | General disorders | 0.8% (1 of 128) | 0.0% | 1 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 0.8% (1 of 128) | 0.0% | 1 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 0.8% (1 of 128) | 0.0% | 1 |
| Cholecystitis | Hepatobiliary disorders | 0.8% (1 of 128) | 0.0% | 1 |
| Fatigue | Blood and lymphatic system disorders | 1.3% (1 of 78) | - | 1 |
| Fever | Blood and lymphatic system disorders | 1.3% (1 of 78) | - | 1 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1.7% (1 of 60) | 5.2% | 1 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 1.7% (1 of 60) | 0.0% | 1 |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | 1.7% (1 of 60) | 0.0% | 1 |
| Facial bones fracture | Injury, poisoning and procedural complications | 0.6% (1 of 155) | - | 1 |
| Injury | Injury, poisoning and procedural complications | 0.6% (1 of 155) | - | 1 |
| Pruritus | Skin and subcutaneous tissue disorders | 0.0% (0 of 156) | 6.9% | 2 |
| Headache/Migraine | Nervous system disorders | 0.0% (0 of 76) | 6.9% | 1 |
| Gingival Infection | Infections and infestations | 0.0% (0 of 80) | - | 1 |
| Dental Caries | Infections and infestations | 0.0% (0 of 80) | - | 1 |
| Dental Operation | Surgical and medical procedures | 0.0% (0 of 80) | - | 1 |
| Aortic Value Sclerosis | Cardiac disorders | 0.0% (0 of 80) | - | 1 |
| Sudden Cardiac Death | General disorders | 0.0% (0 of 80) | - | 1 |
| Myocardial infarction | Cardiac disorders | 0.0% (0 of 128) | 2.2% | 1 |
| Tracheostomy | Surgical and medical procedures | 0.0% (0 of 128) | 2.2% | 1 |
| Blood pressure increased | Investigations | 0.0% (0 of 100) | - | 1 |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | 0.0% (0 of 100) | - | 1 |
| Feeling Hot | General disorders | 0.0% (0 of 100) | - | 1 |
| Local Swelling | General disorders | 0.0% (0 of 100) | - | 1 |
| Edema Peripheral | General disorders | 0.0% (0 of 100) | - | 1 |
| Localized edema | General disorders | 0.0% (0 of 100) | - | 1 |
| Skin Lesion | Skin and subcutaneous tissue disorders | 0.0% (0 of 100) | - | 1 |
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | 0.0% (0 of 100) | - | 1 |
| Rash pruritic | Skin and subcutaneous tissue disorders | 0.0% (0 of 60) | 1.7% | 1 |
| lightheadedness | Cardiac disorders | 0.0% (0 of 66) | 0.0% | 1 |
| COVID-19 infection | Infections and infestations | 0.0% (0 of 66) | 0.0% | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
QUESTIONS
Does icatibant cause hereditary angioedema?
In 4 placebo-controlled trials with posted results, 18.1% of people on icatibant reported hereditary angioedema, against 18.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does icatibant cause headache?
In 4 placebo-controlled trials with posted results, 10.1% of people on icatibant reported headache, against 6.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
37 registered clinical trials of Icatibant
The 10 most recently updated are listed.
| NCT04113109 | Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 Status: COMPLETED · Updated 2026-08-11 |
|---|---|
| NCT05509569 | A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema Status: COMPLETED · Updated 2026-08-07 |
| 2024-516247-62-00 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema Status: UNKNOWN · Updated 2026-07-17 |
| 2023-505766-28-00 | A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema Status: UNKNOWN · Updated 2026-06-01 |
| NCT05834777 | Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor Status: RECRUITING · Updated 2026-04-15 |
| NCT04488081 | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients Status: ACTIVE_NOT_RECRUITING · Updated 2026-03-16 |
| NCT06346899 | A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China Status: COMPLETED · Updated 2026-01-21 |
| NCT07009262 | A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks Status: COMPLETED · Updated 2026-01-13 |
| NCT07290855 | A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema Status: COMPLETED · Updated 2025-12-18 |
| 2023-507268-37-00 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema. Status: UNKNOWN · Updated 2025-09-16 |
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