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Pulmozyme (Dornase Alfa) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pulmozyme (Dornase Alfa) 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 (44)
Death (22)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Death (18)Pneumonia (8)Pyrexia (3)Haemoptysis (3)Drug Ineffective (2)Lung Infection (2)Cough (2)Cystic Fibrosis (2)Asthma (1)Blood Creatine Phosphokinase Increased (1)Rhabdomyolysis (1)Infection (1)

Below are a few examples of reports where side effects / adverse reactions may be related to Pulmozyme (Dornase Alfa). For a complete list or a specific selection of reports, please use the links above.

Possible Pulmozyme side effects in

Reported by a physician from United States on 2012-08-17

Patient:

Reactions: Tracheostomy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female

Reactions: Ill-Defined Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme
    Indication: Cystic Fibrosis

Pulmozyme
    Indication: Cystic Fibrosis Pancreatic

Pulmozyme



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme
    Indication: Cystic Fibrosis Pancreatic

Pulmozyme
    Indication: Cystic Fibrosis



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-08-13

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

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

Patient: male

Reactions: Lung Infection

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-08-10

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female

Reactions: Epistaxis

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in

Reported by a individual with unspecified qualification from United States on 2012-06-12

Patient:

Reactions: Medication Error, Wrong Drug Administered

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-06-04

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Rhabdomyolysis

Drug(s) suspected as cause:
Kalydeco
    Administration route: Oral
    Indication: Cystic Fibrosis
    Start date: 2012-03-26
    End date: 2012-04-23

Pulmozyme
    Indication: Cystic Fibrosis Lung
    Start date: 2008-01-01

Singulair
    Indication: Cystic Fibrosis Lung
    Start date: 2002-01-01
    End date: 2012-02-09

VX-809
    Administration route: Oral
    Indication: Cystic Fibrosis
    Start date: 2012-02-29
    End date: 2012-04-23

Other drugs received by patient: Omeprazole; Ensure; Ciprofloxacin; Albuterol; Levaquin; Golytely; Mass Gainer XXX; Bactrim DS; Sodium Chloride Concentrated INJ; Acetaminophen; Vitamin K TAB; Vitamax; Creon; Albuterol; Aspirin



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-05-16

Patient: male, weighing 56.8 kg (124.9 pounds)

Reactions: Respiratory Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in 44 year old female

Reported by a pharmacist from United States on 2012-05-14

Patient: 44 year old female

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: male

Reactions: Pneumonia, Drug Ineffective, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme

Other drugs received by patient: Albuterol; Vicodin; Levsin PB; Alprazolam



Possible Pulmozyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-25

Patient: male

Reactions: Pneumonia, Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in 44 year old female

Reported by a pharmacist from United States on 2012-04-23

Patient: 44 year old female

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a consumer/non-health professional from Colombia on 2012-03-30

Patient: female

Reactions: Cystic Fibrosis, Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-28

Patient: 65 year old female

Reactions: Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-27

Patient: male

Reactions: Cystic Fibrosis

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a pharmacist from United States on 2012-03-27

Patient: male

Reactions: Incoherent, Victim of Crime

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a physician from United States on 2012-03-22

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme



Possible Pulmozyme side effects in female

Reported by a physician from Germany on 2012-03-09

Patient: female

Reactions: Nasal Oedema, Haemoptysis, Cough

Drug(s) suspected as cause:
Pulmozyme
    Dosage: 0.5 df, qd

Tobi
    Dosage: 4 df, bid
    Indication: Pseudomonas Infection
    Start date: 2011-12-19
    End date: 2012-01-07

Other drugs received by patient: Konakion; Spiriva; Promitin; Fluticasone Propionate; Dekristol; Vitamin A; Albuterol Sulfate; Fluticasone Propionate / Salmeterol; Azithromycin; Vitamin E



Possible Pulmozyme side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pulmozyme

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