This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prolastin (Alpha 1-Antitrypsin) 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 (16)
Life Threatening Events (1)
Disability (2)
Reports by Reaction Type
Chills (2),
Anaphylactic Shock (2),
Influenza Like Illness (2),
Malaise (2),
Infusion Related Reaction (2),
Drug Hypersensitivity (2),
Dermatitis Allergic (1),
Hypersensitivity (1),
Nasopharyngitis (1),
Urticaria (1),
Weight Increased (1),
Palpitations (1)
Possible Prolastin side effects in 53 year old female
Reported by a pharmacist from United States on 2012-05-11
Patient: 53 year old female, weighing 57.1 kg (125.7 pounds)
Reactions: Anxiety, Pruritus, Blood Potassium Decreased, Joint Swelling, Palpitations, Oedema Peripheral, Rash Maculo-Papular, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prolastin
Dosage: 3513 mg;qw;iv
Indication: Alpha-1 Anti-Trypsin Deficiency
Start date: 2012-04-30
End date: 2012-04-30
Diphenhydramine HCL
Dosage: po
Administration route: Oral
Indication: Rash
Start date: 2012-05-01
Diphenhydramine HCL
Dosage: po
Administration route: Oral
Indication: Pruritus
Start date: 2012-05-01
Corticosteroids
Indication: Pruritus
Start date: 2012-05-01
End date: 2012-05-01
Corticosteroids
Indication: Rash
Start date: 2012-05-01
End date: 2012-05-01
Possible Prolastin side effects in 51 year old male
Reported by a physician from Germany on 2012-04-27
Patient: 51 year old male
Reactions: Glioblastoma, Convulsion
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Prolastin
Other drugs received by patient: Forair / 00958002 /; Prednisone; Spiriva
Possible Prolastin side effects in 56 year old female
Reported by a pharmacist from Germany on 2012-04-19
Patient: 56 year old female
Reactions: Dermatitis Allergic, Urticaria
Drug(s) suspected as cause:
Prolastin
Other drugs received by patient: Berodual; Fluticasone Propionate / Salmeterol; Calcimagon / 00751501 /; Prednisone TAB
Possible Prolastin side effects in 51 year old female
Reported by a pharmacist from Portugal on 2012-04-19
Patient: 51 year old female
Reactions: Rash Erythematous
Drug(s) suspected as cause:
Prolastin
Possible Prolastin side effects in 32 year old female
Reported by a pharmacist from Canada on 2012-04-19
Patient: 32 year old female, weighing 72.6 kg (159.7 pounds)
Reactions: Weight Increased
Drug(s) suspected as cause:
Prolastin
Possible Prolastin side effects in 47 year old male
Reported by a physician from Germany on 2012-04-18
Patient: 47 year old male
Reactions: Malaise, Chills, Influenza Like Illness
Drug(s) suspected as cause:
Prolastin
Other drugs received by patient: Budiair; Berotec; Spiriva; Forair / 00958002 /
Possible Prolastin side effects in 51 year old male
Reported by a physician from Germany on 2012-04-18
Patient: 51 year old male
Reactions: Blood Pressure Systolic Increased, Drug Hypersensitivity
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prolastin
Other drugs received by patient: Albuterol; Symbicort
Possible Prolastin side effects in female
Reported by a physician from United States on 2012-04-18
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Prolastin
Possible Prolastin side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18
Patient: 59 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Condition Aggravated, Alpha-1 Anti-Trypsin Deficiency
Drug(s) suspected as cause:
Prolastin
Possible Prolastin side effects in 50 year old female
Reported by a pharmacist from United States on 2012-04-18
Patient: 50 year old female
Reactions: Hypersensitivity, Influenza Like Illness
Drug(s) suspected as cause:
Prolastin
Possible Prolastin side effects in 60 year old male
Reported by a physician from Germany on 2012-04-18
Patient: 60 year old male
Reactions: Flushing, Chills
Drug(s) suspected as cause:
Prolastin
Possible Prolastin side effects in 66 year old female
Reported by a physician from United States on 2012-04-18
Patient: 66 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Drug Effect Decreased, Malaise, Unevaluable Event, Asthenia
Drug(s) suspected as cause:
Prolastin-C
Dosage: 60 mg/kg;qw;iv
Indication: Alpha-1 Anti-Trypsin Deficiency
Start date: 2010-01-01
Prolastin
Dosage: qm;iv
Indication: Alpha-1 Anti-Trypsin Deficiency
Start date: 2003-01-01
Possible Prolastin side effects in 54 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-11
Patient: 54 year old female
Reactions: Nasopharyngitis, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prolastin
Other drugs received by patient: Oxycontin; Percocet; Albuterol
Possible Prolastin side effects in 45 year old female
Reported by a physician from Germany on 2012-02-24
Patient: 45 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Product Quality Issue, Heart Rate Decreased, Anaphylactic Shock
Drug(s) suspected as cause:
Prolastin
Other drugs received by patient: Citalopram Hydrobromide; Theophylline; Fluticasone Propionate W / Salmeterol; Nasic; Fenoterol W / Ipratropium Bromide; Reactine DUO; Spiriva; Omeprazole; Dipyrone TAB; Acetaminophen
Possible Prolastin side effects in 45 year old female
Reported by a physician from Germany on 2012-02-06
Patient: 45 year old female
Reactions: Anaphylactic Shock, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prolastin
Other drugs received by patient: Fluticasone Propionate W / Salmeterol; Fenoterol W / Ipratropium Bromide; Spiriva; Theophylline; Citalopram Hydrobromide
Possible Prolastin side effects in 28 year old female
Reported by a individual with unspecified qualification from United Kingdom on 2011-10-12
Patient: 28 year old female
Reactions: Incorrect Drug Administration Rate, Dizziness, Coordination Abnormal, Dysphemia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Prolastin
Dosage: 40 ml;qow;iv
Indication: Alpha-1 Anti-Trypsin Deficiency
Start date: 2005-01-01
Prolastin
Dosage: 40 ml;qow;iv
Indication: Panniculitis
Start date: 2005-01-01
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