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Cinryze (Human C1-Esterase Inhibitor) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cinryze (Human C1-Esterase Inhibitor) 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 (221)
Death (12)
Life Threatening Events (3)
Disability (2)

Reports by Reaction Type

Hereditary Angioedema (109)Inappropriate Schedule of Drug Administration (40)Device Related Infection (32)Off Label Use (26)Angioedema (25)Headache (23)Infusion Related Reaction (22)Drug Dose Omission (17)Convulsion (17)Maternal Exposure During Pregnancy (16)Therapy Regimen Changed (15)Pulmonary Embolism (13)

Below are a few examples of reports where side effects / adverse reactions may be related to Cinryze (Human C1-Esterase Inhibitor). For a complete list or a specific selection of reports, please use the links above.

Possible Cinryze side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female, weighing 98.4 kg (216.5 pounds)

Reactions: Abdominal Pain, Nausea, Hypotension, Bundle Branch Block Right, Pulmonary Embolism, Convulsion, Syncope, Abdominal Distension, Cardiac Arrest, Oxygen Saturation Decreased

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Cinryze
    Start date: 2012-07-09
    End date: 2012-07-09

Cinryze
    Start date: 2011-11-07
    End date: 2011-11-07

Cinryze
    Start date: 2012-07-09
    End date: 2012-07-09

Cinryze
    Start date: 2010-11-27
    End date: 2010-11-27

Cinryze
    Start date: 2010-11-27
    End date: 2010-11-27

Cinryze
    Start date: 2012-02-06
    End date: 2012-02-06

Cinryze
    Start date: 2011-08-24
    End date: 2011-08-24

Cinryze
    Start date: 2012-02-06
    End date: 2012-02-06

Cinryze
    Start date: 2011-11-07
    End date: 2011-11-07

Cinryze
    Start date: 2012-06-28
    End date: 2012-06-28

Cinryze
    Start date: 2012-02-13
    End date: 2012-02-13

Cinryze
    Start date: 2011-08-24
    End date: 2011-08-24

Cinryze
    Start date: 2012-02-13
    End date: 2012-02-13

Cinryze
    Start date: 2009-10-01
    End date: 2009-10-01

Cinryze
    Start date: 2012-06-28
    End date: 2012-06-28

Cinryze
    Start date: 2010-11-27
    End date: 2010-11-27

Cinryze
    Indication: Hereditary Angioedema
    Start date: 2012-07-09
    End date: 2012-07-09

Cinryze
    Indication: Abdominal Distension
    Start date: 2012-02-06
    End date: 2012-02-06

Cinryze
    Indication: Nausea
    Start date: 2010-11-27
    End date: 2010-11-27

Cinryze
    Start date: 2012-06-28
    End date: 2012-06-28

Cinryze
    Start date: 2011-08-24
    End date: 2011-08-24

Cinryze
    Start date: 2012-02-06
    End date: 2012-02-06

Cinryze
    Start date: 2009-10-01
    End date: 2009-10-01

Cinryze
    Start date: 2012-02-13
    End date: 2012-02-13

Cinryze
    Start date: 2011-11-07
    End date: 2011-11-07

Cinryze
    Start date: 2012-02-13
    End date: 2012-02-13

Cinryze
    Start date: 2012-07-09
    End date: 2012-07-09

Cinryze
    Start date: 2009-10-01
    End date: 2009-10-01

Cinryze
    Start date: 2011-08-24
    End date: 2011-08-24

Cinryze
    Indication: Pain
    Start date: 2009-10-01
    End date: 2009-10-01

Cinryze
    Start date: 2011-11-07
    End date: 2011-11-07

Cinryze
    Start date: 2012-06-28
    End date: 2012-06-28

Nuvaring
    Indication: Contraception
    Start date: 2011-08-27
    End date: 2011-09-24

Ortho TRI-Cyclen LO
    Administration route: Oral
    Indication: Contraception
    Start date: 2012-06-21

Other drugs received by patient: Melatonin; Epipen; Fexofenadine; Fexofenadine; Metoprolol Tartrate; Nortriptyline; Clonazepam; Prilosec; Citalopram Hydrobromide; Remeron



Possible Cinryze side effects in female

Reported by a physician on 2012-08-27

Patient: female

Reactions: Inappropriate Schedule of Drug Administration, Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-21

Patient: female, weighing 98.5 kg (216.7 pounds)

Reactions: Off Label Use, Syncope, Acute Sinusitis, Cerebral Infarction, Hereditary Angioedema, Pulmonary Embolism, Depression, Cardiac Arrest, Convulsion

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Cinryze
    Start date: 2011-11-07
    End date: 2011-11-07

Cinryze
    Indication: Hereditary Angioedema
    Start date: 2009-10-01
    End date: 2009-10-01

Cinryze
    Start date: 2012-07-09

Cinryze
    Start date: 2011-08-24
    End date: 2011-08-24

Cinryze
    Start date: 2012-02-06
    End date: 2012-02-06

Cinryze
    Start date: 2012-02-13
    End date: 2012-02-13

Cinryze
    Start date: 2012-06-28
    End date: 2012-06-28

Cinryze
    Start date: 2010-11-27
    End date: 2010-11-27

Nuvaring
    Indication: Contraception
    Start date: 2011-09-03
    End date: 2011-09-24

Ortho TRI-Cyclen LO
    Indication: Contraception

Other drugs received by patient: Citalopram Hydrobromide; Epipen; Metoprolol Tartrate; Melatonin; Clonazepam; Fexofenadine; Remeron; Nortriptyline; Prilosec



Possible Cinryze side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Drug Dose Omission, Angioedema, Fatigue, Food Allergy, Blood Potassium Decreased, Hereditary Angioedema, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze

Other drugs received by patient: Vicodin; Hydrochlorothiazide; Doxepin; Zantac; Singulair; Spironolactone; Xanax



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female, weighing 56.3 kg (123.9 pounds)

Reactions: Contusion, Pneumonia, Goitre, Anaemia, Hereditary Angioedema, Intervertebral Disc Degeneration, Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Indication: Hereditary Angioedema
    Start date: 2011-02-11

Prednisone
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Dosage: unknown
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Albuterol; Dilaudid; Fioricet; Nortriptyline; Ibuprofen; Tylenol; Colace; Miralax; Metamucil-2; Probiotics; Dilantin; Oxycodone HCL; Diphenhydramine Hydrochloride; Phenergan HCL; Ferrous Gluconate; Zofran; Dulcolax; Danazol; Prevacid; Trazodone Hydrochloride; Epipen; Docusate; Fosamax; Spiriva; Magnesium Citrate; Asmanex Twisthaler; Atenolol; Nasonex; Soma; Enema



Possible Cinryze side effects in 44 year old female

Reported by a physician from United States on 2012-08-21

Patient: 44 year old female, weighing 56.2 kg (123.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Urinary Tract Infection, Anaemia, Prothrombin Time Prolonged, Transaminases Increased, Hepatic Enzyme Increased, Hereditary Angioedema, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: 1000 unit , 3x/week
    Indication: Hereditary Angioedema
    Start date: 2010-01-01

Lipitor
    Indication: Blood Triglycerides

Lipitor
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2009-04-01
    End date: 2012-01-01

Other drugs received by patient: Oxycodone; Trazodone; Trazodone; Soma; Fosamax; Ibuprofen; Tylenol; Dulcolax; Restoril; Epipen; Nortriptyline; Phenargan; Zofran; Tylenol; Dilantin; Aspirin; Coumadin; Prevacid; Miralax; Dilantin; Zoloft; Asmanex Twisthaler; Danazol; Diphenhydramine; Ferrous Gluconate; Fioricet; Warfarin; Dilaudid; Kalbitor; Nortriptyline; Warfarin; Soma; Colace; Flexeril; Atenolol; Nasonex; Warfarin; Spiriva; Magnesium Citrate; Albuterol; Danazol; Dilaudid; Warfarin; Spiriva; Probiotics; Metamucil-2; Iron



Possible Cinryze side effects in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 44 year old female, weighing 56.2 kg (123.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Anaemia, Urinary Tract Infection, Prothrombin Time Prolonged, Transaminases Increased, Hepatic Enzyme Increased, Hereditary Angioedema, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: 1000 unit , 3x/week
    Indication: Hereditary Angioedema
    Start date: 2010-01-01

Lipitor
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2009-04-01
    End date: 2012-01-01

Lipitor
    Indication: Blood Triglycerides

Other drugs received by patient: Phenargan; Ibuprofen; Spiriva; Probiotics; Asmanex Twisthaler; Diphenhydramine; Fosamax; Warfarin; Warfarin; Soma; Trazodone; Tylenol; Miralax; Iron; Albuterol; Danazol; Dilaudid; Trazodone; Warfarin; Spiriva; Colace; Ferrous Gluconate; Nortriptyline; Prevacid; Zofran; Zoloft; Restoril; Magnesium Citrate; Atenolol; Dilaudid; Dilantin; Flexeril; Epipen; Fioricet; Kalbitor; Nortriptyline; Tylenol; Danazol; Nasonex; Oxycodone; Warfarin; Soma; Dulcolax; Dilantin; Metamucil-2; Aspirin; Coumadin



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-08-15

Patient: female

Reactions: Compartment Syndrome, Hereditary Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: unknown
    Indication: Hereditary Angioedema
    End date: 2012-04-01

Cinryze
    Start date: 2012-07-01



Possible Cinryze side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 47 year old female

Reactions: Inappropriate Schedule of Drug Administration, Back Pain, Medical Device Complication, Angioedema, Enterococcal Infection, Device Related Infection, Central Venous Catheterisation, Hereditary Angioedema, Drug Dependence, Catheter Site Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: 1000 units, 2x/week
    Indication: Hereditary Angioedema
    Start date: 2012-02-01

Xanax
    Dosage: 2 mg, 3x/day
    Indication: Anxiety

Other drugs received by patient: Prednisone; Effexor; Imitrex; Zoloft; Neurontin; Synthroid; Claritin; Remeron; Keppra; Fioricet



Possible Cinryze side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: female, weighing 73.2 kg (161.0 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Drug Dose Omission, Vomiting, Hypotension, Maternal Exposure During Pregnancy, Urinary Tract Infection, Pyrexia, Headache, Paraesthesia, Upper Respiratory Tract Infection, Dehydration, Hereditary Angioedema, Therapy Regimen Changed, Arthropod Bite, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Indication: Hereditary Angioedema
    Start date: 2009-01-01
    End date: 2012-01-01

Cinryze
    Start date: 2012-01-01

Other drugs received by patient: Vicodin; Nexium; Xanax; Multi-Vitamins



Possible Cinryze side effects in male

Reported by a physician from United States on 2012-08-09

Patient: male

Reactions: Device Related Sepsis, Mental Impairment, Underdose, Streptococcal Infection, Product Reconstitution Issue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-07

Patient: female

Reactions: Back Pain, Inappropriate Schedule of Drug Administration, Medical Device Complication, Angioedema, Central Venous Catheterisation, Enterococcal Infection, Hereditary Angioedema, Device Related Infection, Drug Dependence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Indication: Hereditary Angioedema
    Start date: 2012-02-01

Xanax
    Indication: Anxiety

Other drugs received by patient: Neurontin; Keppra; Prednisone; Remeron; Effexor; Imitrex; Claritin; Fioricet; Synthroid; Zoloft



Possible Cinryze side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: male, weighing 104.8 kg (230.5 pounds)

Reactions: Oedema Peripheral, Abdominal Distension, Venous Thrombosis, Catheter Site Infection, Wound Infection Staphylococcal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Berinert
    Dosage: (??-may-2012 intravenous (not otherwise specified))
    Indication: Hereditary Angioedema

Cinryze
    Dosage: see image
    Indication: Hereditary Angioedema
    End date: 2012-07-19



Possible Cinryze side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female

Reactions: Pharyngeal Disorder, Pharyngitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a pharmacist from United States on 2012-08-07

Patient: female

Reactions: Inappropriate Schedule of Drug Administration, Condition Aggravated, Myelitis Transverse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: female

Reactions: Angioedema, Nausea, Pain, Pulmonary Embolism, Bundle Branch Block Right, Cerebrovascular Accident, Convulsion, Syncope, Abdominal Distension, Hemiplegia, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cinryze
    Indication: Hereditary Angioedema
    Start date: 2012-07-09

Cinryze
    Dosage: 1000 units
    Start date: 2009-10-01

Cinryze
    Start date: 2011-08-01

Norgestimate and Ethinyl Estradiol
    Indication: Contraception

Other drugs received by patient: Metoprolol Tartrate; Fexofenadine; Nortriptyline HCL; Klonopin; Omeprazole; Celexa



Possible Cinryze side effects in male

Reported by a physician from United States on 2012-08-06

Patient: male, weighing 43.1 kg (94.8 pounds)

Reactions: Drug Hypersensitivity, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: 1500 unit, unk
    Indication: Prophylaxis
    Start date: 2010-08-01
    End date: 2012-03-01

Dilaudid
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-01



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-08-06

Patient: female, weighing 87.2 kg (191.8 pounds)

Reactions: Product Quality Issue, Back Pain, Nausea, Headache, Malaise, Diarrhoea, Hereditary Angioedema, Dizziness, Feeling Abnormal, Infusion Related Reaction

Drug(s) suspected as cause:
Cinryze
    Dosage: infused via central line over 10 minutes
    Indication: Hereditary Angioedema
    Start date: 2011-05-01
    End date: 2011-08-01

Depakote ER
    Administration route: Oral
    Indication: Headache
    End date: 2011-08-23

Other drugs received by patient: Excedrin Extra Strength Tablets; Ibuprofen; Topamax; Flexeril; Lortab; Benadryl; Prilosec; Excedrin Extra Strength Tablets; Ibuprofen; Neurontin; Kalbitor; Klonopin; Amitriptyline HCL; Tramadol HCL; Ibuprofen; Celexa; Lamictal; Klonopin



Possible Cinryze side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in male

Reported by a physician from United States on 2012-08-01

Patient: male

Reactions: Inappropriate Schedule of Drug Administration, Agitation, Peptic Ulcer, Pyrexia, Diverticulum Intestinal, Gastritis, Fatigue, Dyspepsia, Hereditary Angioedema, Gastrooesophageal Reflux Disease, Gastroduodenitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: 1000 unit, 3 in 1 wk
    Indication: Prophylaxis
    Start date: 2010-09-17

Ibuprofen (Advil)
    Dosage: 3-4 tablets a day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Cinryze side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-07-31

Patient: female

Reactions: Drug Dose Omission, Device Related Sepsis, Product Quality Issue, Staphylococcal Sepsis, Central Venous Catheter Removal, Infusion Related Reaction, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-07-30

Patient: female

Reactions: Off Label Use, Syncope, Pulmonary Embolism, Hereditary Angioedema, Cerebrovascular Accident, Cardiac Arrest, Convulsion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cinryze
    Indication: Hereditary Angioedema
    Start date: 2009-10-01

Ortho TRI-Cyclen LO
    Dosage: unknown
    Indication: Contraception

Other drugs received by patient: Metoprolol Tartrate; Nortriptyline HCL; Omeprazole; Fexofenadine; Klonopin; Celexa



Possible Cinryze side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: male

Reactions: Mental Impairment, Device Related Sepsis, Underdose, Streptococcal Infection, Product Reconstitution Issue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-07-25

Patient: female, weighing 56.2 kg (123.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Urinary Tract Infection, Pancreatitis, Hereditary Angioedema, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Dosage: 1000 unit , 3x/week
    Indication: Hereditary Angioedema
    Start date: 2010-01-01

Lipitor
    Dosage: 40 mg, 1 in 1 d
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2012-01-01

Other drugs received by patient: Diphenhydramine; Fosamax; Kalbitor; Dilantin; Atenolol; Nortriptyline; Trazodone; Warfarin; Warfarin; Nasonex; Miralax; Dilantin; Magnesium Citrate; Danazol; Fioricet; Ibuprofen; Soma; Oxycodone; Phenargan; Prevacid; Metamucil-2; Ferrous Gluconate; Colace; Asmanex Twisthaler; Warfarin; Spiriva; Soma; Dulcolax; Epipen; Albuterol; Dilaudid; Nortriptyline; Phenargan; Zofran; Tylenol; Probiotics



Possible Cinryze side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-25

Patient: male, weighing 104.9 kg (230.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Thrombosis, Headache, Device Related Infection, Treatment Noncompliance, Staphylococcal Infection, Poor Venous Access, Hereditary Angioedema, Catheter Site Infection, Jugular Vein Thrombosis, Thrombosis in Device

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Berinert
    Dosage: unknown
    Indication: Hereditary Angioedema

Cinryze
    Start date: 2012-01-01

Cinryze
    Indication: Hereditary Angioedema
    Start date: 2011-10-01
    End date: 2012-01-01

Cinryze

Other drugs received by patient: Lovenox; Unspecifed Insulin; Coumadin



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-07-24

Patient: female

Reactions: Hereditary Angioedema, Pulmonary Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze

Other drugs received by patient: Synthroid; Vitamin B-12; Lovastatin; Humulin N; Zaroxolyn; Bumex; Potassium Chloride; Aldactone; Hydralazine HCL; Procardia XL; Firazyr; Acetazolamide; Humulin R



Possible Cinryze side effects in female

Reported by a physician from United States on 2012-07-24

Patient: female

Reactions: Drug Dose Omission, Device Related Sepsis, Pseudomonal Sepsis, Staphylococcal Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze
    Indication: Hereditary Angioedema
    Start date: 2012-02-01
    End date: 2012-06-01

Cinryze
    Start date: 2012-07-01

Other drugs received by patient: Advair Diskus 100 / 50; Valproic Acid; Albuterol



Possible Cinryze side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient: female

Reactions: Haemoglobin Decreased, Gastrointestinal Haemorrhage, Poor Venous Access, Hereditary Angioedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze



Possible Cinryze side effects in female

Reported by a pharmacist from United States on 2012-07-19

Patient: female

Reactions: Inappropriate Schedule of Drug Administration, Pneumonia, Hereditary Angioedema, Endocarditis, Therapy Regimen Changed, Device Related Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cinryze

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