This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Kalbitor (Ecallantide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (57)
Death (5)
Life Threatening Events (1)
Reports by Reaction Type
Hereditary Angioedema (25),
Hypersensitivity (6),
Drug Ineffective FOR Unapproved Indication (6),
Pulmonary Embolism (6),
Anaphylactic Reaction (5),
Pancreatitis (5),
Hypertension (5),
Blood Glucose Increased (4),
Angioedema (4),
Feeling Abnormal (4),
Abdominal Pain (3),
Drug Ineffective (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Kalbitor (Ecallantide). For a complete list or a specific selection of reports, please use the links above.
Possible Kalbitor side effects in 35 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 35 year old female
Reactions: Injection Site Erythema, Hypersensitivity, Injection Site Swelling, Injection Site Pruritus
Drug(s) suspected as cause:
Kalbitor
Start date: 2012-07-01
End date: 2012-07-01
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-07-01
End date: 2012-07-01
Other drugs received by patient: Firazyr
Possible Kalbitor side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: 69 year old female, weighing 86.2 kg (189.6 pounds)
Reactions: Anxiety, Blood Pressure Increased, Injection Site Erythema, Anaphylactic Reaction
Drug(s) suspected as cause:
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-26
Kalbitor
Start date: 2012-07-28
End date: 2012-07-28
Other drugs received by patient: Tylenol (Caplet); Amlodipine; Firazyr; Omeprazole; Crestor; Estradiol; Berinert; Danazol; Tirosint
Possible Kalbitor side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: female
Reactions: Injection Site Reaction, Anaphylactic Reaction, Sinusitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Other drugs received by patient: Cinryze
Possible Kalbitor side effects in 46 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06
Patient: 46 year old female
Reactions: Abdominal Pain, Aspartate Aminotransferase Increased, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Hereditary Angioedema, Hyponatraemia, Constipation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Danazol
Indication: Product Used FOR Unknown Indication
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-18
End date: 2012-04-18
Opioids
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Cinryze; Dilantin; Coumadin
Possible Kalbitor side effects in 46 year old female
Reported by a physician from United States on 2012-08-06
Patient: 46 year old female, weighing 77.1 kg (169.6 pounds)
Reactions: Abdominal Pain, Head Injury, Blood Albumin Decreased, Blood Calcium Decreased, Hereditary Angioedema, Intervertebral Disc Degeneration, Blood Sodium Decreased, Blood Glucose Increased, Back Pain, Pneumonia, Chest Discomfort, Anaemia, Toxicity To Various Agents, Protein Total Decreased, Increased Tendency To Bruise, Blood Urea Decreased, Thyroid Neoplasm
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-07-07
End date: 2012-07-07
Prednisone TAB
Indication: Product Used FOR Unknown Indication
Coumadin
Indication: Anticoagulant Therapy
Start date: 2011-01-01
Other drugs received by patient: Phenergan; Cinryze; Asmanex Twisthaler; Dilaudid; Zofran; Tylenol (Caplet); Metamucil / 00029101 /; Enema / 01318702 /; Dilantin; Dilantin; Oxycodone HCL; Ibuprofen; Miralax / 00754501 /; Ferrous Gluconate; Fioricet; Lipitor; Prevacid; Colace; Dulcolax; Epipen; Atenolol; Fosamax; Probiotics; Diphenhydramine HCL; Nasonex; Nortriptyline HCL; Trazodone Hydrochloride; Magnesium Citrate; Zofran; Soma; Danazol; Albuterol; Spiriva
Possible Kalbitor side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Flushing, Feeling Jittery, Dizziness, Hereditary Angioedema, Feeling Abnormal, Hypertension, Muscle Spasms
Drug(s) suspected as cause:
Hydrochlorothiazide
Dosage: 25 milligram;
Indication: Hypertension
Start date: 2012-06-25
End date: 2012-06-26
Kalbitor
Dosage: 30 milligram; total number doses 12 or 13
Indication: Hereditary Angioedema
Start date: 2011-11-01
Kalbitor
Dosage: 30 milligram;
Start date: 2012-06-26
End date: 2012-06-26
Possible Kalbitor side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-07-09
Patient: 50 year old female, weighing 68.0 kg (149.7 pounds)
Reactions: Flushing, Feeling Jittery, Hereditary Angioedema, Dizziness, Hypertension, Feeling Abnormal, Muscle Spasms
Drug(s) suspected as cause:
Hydrochlorothiazide
Indication: Hypertension
Start date: 2012-06-25
End date: 2012-06-26
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-06-26
End date: 2012-06-26
Kalbitor
Start date: 2011-11-01
Possible Kalbitor side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: 46 year old female
Reactions: Abdominal Pain, Alanine Aminotransferase Increased, International Normalised Ratio Increased, Aspartate Aminotransferase Increased, Hyponatraemia, Hereditary Angioedema, Constipation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Opioids
Indication: Product Used FOR Unknown Indication
Danazol
Indication: Product Used FOR Unknown Indication
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-18
End date: 2012-04-18
Kalbitor
Start date: 2012-06-21
End date: 2012-06-21
Other drugs received by patient: Coumadin; Cinryze; Dilantin
Possible Kalbitor side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-06-29
Patient: 46 year old female
Reactions: Accidental Overdose, Cardiac Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
ALL Other Therapeutic Products
Indication: Product Used FOR Unknown Indication
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-05-30
End date: 2012-05-30
Possible Kalbitor side effects in 24 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29
Patient: 24 year old female, weighing 84.8 kg (186.6 pounds)
Reactions: Hypersensitivity, Hereditary Angioedema, Panic Reaction
Drug(s) suspected as cause:
Kalbitor
Other drugs received by patient: Nasonex; Nasonex; Firazyr; Albuterol; Allegra; Advair Diskus 100 / 50
Possible Kalbitor side effects in 24 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19
Patient: 24 year old female, weighing 84.8 kg (186.6 pounds)
Reactions: Flushing, Pruritus, Hereditary Angioedema, Panic Reaction, Abdominal Pain Upper
Drug(s) suspected as cause:
Kalbitor
Other drugs received by patient: Firazyr; Allegra; Nasonex; Advair Diskus 100 / 50; Albuterol; Nasonex
Possible Kalbitor side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: 46 year old female
Reactions: Breast Cancer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Possible Kalbitor side effects in female
Reported by a physician from United States on 2012-06-14
Patient: female, weighing 99.5 kg (218.9 pounds)
Reactions: Visual Acuity Reduced, Blood Potassium Decreased, Dehydration, Vision Blurred, Hereditary Angioedema, Blood Glucose Increased, Diabetes Mellitus Inadequate Control, Sudden Onset of Sleep
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mirapex
Dosage: 1 mg
Indication: Restless Legs Syndrome
Start date: 2007-01-01
Kalbitor
Dosage: 30 mg
Indication: Hereditary Angioedema
Start date: 2012-05-07
End date: 2012-05-07
Other drugs received by patient: Cinryze; Metformin HCL; Atenolol
Possible Kalbitor side effects in 39 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30
Patient: 39 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Anaphylactic Shock, Hereditary Angioedema, Gastroenteritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Other drugs received by patient: Zofran; Zofran; Zofran
Possible Kalbitor side effects in male
Reported by a individual with unspecified qualification from United States on 2012-05-29
Patient: male, weighing 109.0 kg (239.7 pounds)
Reactions: Incorrect Drug Administration Duration, Hereditary Angioedema, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Indication: Hereditary Angioedema
Start date: 2009-01-01
Cinryze
Indication: Hereditary Angioedema
Other drugs received by patient: Gleevec; Firazyr
Possible Kalbitor side effects in 30 year old female
Reported by a physician from United States on 2012-05-25
Patient: 30 year old female, weighing 103.5 kg (227.7 pounds)
Reactions: Device Related Sepsis, Hereditary Angioedema, Pulmonary Embolism, Drug Interaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Start date: 2012-01-27
End date: 2012-01-27
Cinryze
Start date: 2012-01-01
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-01-26
End date: 2012-01-26
Kalbitor
Start date: 2012-02-01
End date: 2012-02-01
Cinryze
Indication: Hereditary Angioedema
Start date: 2012-02-10
End date: 2012-03-18
Cinryze
Start date: 2012-03-21
End date: 2012-03-21
Kalbitor
Start date: 2012-03-20
End date: 2012-03-20
Other drugs received by patient: Coreg; Lexapro; Insulin; Allergy Medication
Possible Kalbitor side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female
Reactions: Abortion Spontaneous, Drug Dispensing Error
Drug(s) suspected as cause:
Metformin HCL
Dosage: 500 mg, bid
Administration route: Oral
Indication: Polycystic Ovaries
Start date: 2012-01-01
Metformin HCL
Dosage: 1000 mg, bid
Administration route: Oral
Start date: 2012-01-01
Kalbitor
Dosage: 30 mg, x1
Indication: Hereditary Angioedema
Start date: 2011-12-29
End date: 2011-12-29
Other drugs received by patient: Thyroid TAB; Prometrium; Clomid
Possible Kalbitor side effects in 46 year old female
Reported by a physician from United States on 2012-05-21
Patient: 46 year old female
Reactions: Drug Ineffective FOR Unapproved Indication, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Indication: Abdominal Pain
Start date: 2012-04-04
End date: 2012-04-04
Kalbitor
Indication: Abdominal Distension
Start date: 2012-04-04
End date: 2012-04-04
Kalbitor
Start date: 2012-04-04
End date: 2012-04-04
Kalbitor
Start date: 2012-04-04
End date: 2012-04-04
Possible Kalbitor side effects in 17 year old female
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: 17 year old female
Reactions: Hereditary Angioedema, Device Related Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Start date: 2012-05-01
End date: 2012-05-01
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-28
End date: 2012-04-28
Other drugs received by patient: Corticosteroids; Berinert; Cinryze; Phenergan; Benadryl
Possible Kalbitor side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-15
Patient: female
Reactions: Incorrect Dose Administered, Maternal Exposure During Pregnancy, Drug Dispensing Error, Abortion Spontaneous
Drug(s) suspected as cause:
Kalbitor
Dosage: 30 mg x1, subcutaneous
Indication: Hereditary Angioedema
Start date: 2009-01-01
Berinert
Indication: Hereditary Angioedema
Metformin HCL
Dosage: 1000 mg, bid, (500 mg, bid)
Indication: Polycystic Ovaries
Start date: 2012-01-01
End date: 2012-01-01
Metformin HCL
Dosage: 1000 mg, bid, (500 mg, bid)
Indication: Polycystic Ovaries
Start date: 2012-01-01
Other drugs received by patient: Prometrium; Clomid; Thyroid TAB
Possible Kalbitor side effects in female
Reported by a individual with unspecified qualification from United States on 2012-05-15
Patient: female, weighing 87.5 kg (192.6 pounds)
Reactions: Anxiety, Fatigue, Arthralgia, Pain in Extremity, Musculoskeletal Pain, Sensory Disturbance, Condition Aggravated, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Dosage: (30 ml total, 30 ml as a single dose)
Indication: Hereditary Angioedema
Start date: 2012-03-23
End date: 2012-03-23
Berinert
Dosage: (intravenous (not otherwise specified))
Indication: Hereditary Angioedema
Start date: 2012-03-22
End date: 2012-03-22
Corticosteroids (Corticosteroids)
Dosage: (intravenous (not otherwise specified))
Indication: Hereditary Angioedema
Start date: 2012-03-01
End date: 2012-03-01
Corticosteroids (Corticosteroids)
Dosage: (oral)
Administration route: Oral
Indication: Hereditary Angioedema
Start date: 2012-03-01
End date: 2012-03-01
Other drugs received by patient: Nexium; Proair (Salbutamol Sulfate); Divigel (Estradiol); Qvar; Multivitamin (Multivitamin / 00831701 / ); Lipitor
Possible Kalbitor side effects in 32 year old male
Reported by a physician from United States on 2012-05-14
Patient: 32 year old male, weighing 108.9 kg (239.5 pounds)
Reactions: Dyspnoea, Chest Pain, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-03-04
End date: 2012-03-04
Cinryze
Dosage: dose unit:1000 units
Indication: Hereditary Angioedema
Start date: 2012-03-31
End date: 2012-03-31
Other drugs received by patient: Gleevec; Firazyr; Firazyr; Firazyr
Possible Kalbitor side effects in female
Reported by a physician from United States on 2012-05-14
Patient: female, weighing 103.5 kg (227.7 pounds)
Reactions: Angioedema, Sepsis, Pulmonary Embolism, Hereditary Angioedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cinryze
Indication: Hereditary Angioedema
Start date: 2012-02-10
End date: 2012-03-22
Kalbitor
Dosage: unknown
Indication: Hereditary Angioedema
Start date: 2012-01-26
Unspecified Allergy Injection
Dosage: unknown
Indication: Hypersensitivity
Start date: 2012-03-20
End date: 2012-03-20
Other drugs received by patient: Coreg; Apidra; Lexapro
Possible Kalbitor side effects in 39 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11
Patient: 39 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Anaphylactic Shock, Hereditary Angioedema, Gastroenteritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Possible Kalbitor side effects in 29 year old female
Reported by a physician from United States on 2012-05-04
Patient: 29 year old female
Reactions: Therapeutic Response Decreased, Urinary Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Other drugs received by patient: Cinryze; Berinert
Possible Kalbitor side effects in female
Reported by a pharmacist from United States on 2012-05-04
Patient: female, weighing 82.6 kg (181.8 pounds)
Reactions: Drug Ineffective, Sepsis, Hereditary Angioedema, Nasal Congestion, Device Related Infection, Hypertension, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Start date: 2011-12-01
End date: 2011-12-01
Kalbitor
Start date: 2011-12-01
End date: 2011-12-01
Cinryze
Dosage: unknown
Indication: Hereditary Angioedema
Kalbitor
Indication: Hereditary Angioedema
Start date: 2011-11-14
End date: 2011-11-14
Other drugs received by patient: Loratadine; Acetic Acid; Android 5; Hydroxyzine; Ferrous Sulfate TAB; Protonix; Epipen; Nystatin; Phenergan
Possible Kalbitor side effects in 54 year old female
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: 54 year old female, weighing 92.1 kg (202.6 pounds)
Reactions: Therapeutic Response Decreased, Coronary Artery Occlusion, Electrocardiogram Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-15
End date: 2012-04-15
Kalbitor
Start date: 2012-04-15
End date: 2012-04-15
Other drugs received by patient: Oxandrin
Possible Kalbitor side effects in 33 year old female
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: 33 year old female
Reactions: Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Metformin HCL
Start date: 2012-01-01
Berinert
Indication: Hereditary Angioedema
Kalbitor
Indication: Hereditary Angioedema
Start date: 2011-12-29
End date: 2011-12-29
Metformin HCL
Indication: Polycystic Ovaries
Start date: 2012-01-01
End date: 2012-01-01
Other drugs received by patient: Prometrium; Thyroid TAB; Clomid
Possible Kalbitor side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: 46 year old female
Reactions: Drug Ineffective FOR Unapproved Indication, Pancreatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kalbitor
Start date: 2012-04-04
End date: 2012-04-04
Kalbitor
Indication: Hereditary Angioedema
Start date: 2012-04-04
End date: 2012-04-04
Possible Kalbitor side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: 48 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Therapeutic Response Decreased, Hypersensitivity, Dyspnoea, Drug Ineffective FOR Unapproved Indication, Erythema
Drug(s) suspected as cause:
Kalbitor
Indication: Hereditary Angioedema
Kalbitor
Start date: 2012-03-15
End date: 2012-03-15
Other drugs received by patient: Danazol; Cinryze; Firazyr
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