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Gammaplex (Human Immunoglobulin G) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Gammaplex (Human Immunoglobulin G) 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 (10)
Disability (2)

Reports by Reaction Type

International Normalised Ratio Decreased (4)Pulmonary Embolism (3)Drug Interaction (2)Headache (2)Pyrexia (2)Chest Pain (2)Abdominal Pain (1)Chills (1)Tachycardia (1)Viith Nerve Paralysis (1)Weight Increased (1)Fatigue (1)

Possible Gammaplex side effects in female

Reported by a pharmacist from United States on 2012-06-14

Patient: female, weighing 96.6 kg (212.6 pounds)

Reactions: Weight Increased, Swelling Face, Oedema Peripheral

Drug(s) suspected as cause:
Gammaplex



Possible Gammaplex side effects in female

Reported by a physician from United States on 2012-06-14

Patient: female

Reactions: Migraine, Product Substitution Issue, Dyspnoea, Chest Pain, Wheezing, Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammaplex



Possible Gammaplex side effects in 53 year old female

Reported by a pharmacist from United Kingdom on 2012-05-15

Patient: 53 year old female, weighing 110.0 kg (242.0 pounds)

Reactions: International Normalised Ratio Decreased, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammaplex

Other drugs received by patient possibly interacting with the suspect drug:
Warfarin Sodium
    Dosage: unknown dosage
    Indication: Pulmonary Embolism

Other drugs received by patient: Pantoprazole; Ramipril; Acetaminophen; Ursodiol; Phenoxymethylpenicillin; Fluticasone Propionate; Tramadol Hydrochloride



Possible Gammaplex side effects in 53 year old female

Reported by a pharmacist from United Kingdom on 2012-04-09

Patient: 53 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: International Normalised Ratio Increased, International Normalised Ratio Decreased, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammaplex

Other drugs received by patient: Warfarin; Ramipril; Acetaminophen; Tramadol Hydrochloride; Pantoprazole; Ursodiol; Phenoxymethylpenicillin; Fluticasone Propionate Inhaler



Possible Gammaplex side effects in 53 year old female

Reported by a pharmacist from United Kingdom on 2012-03-26

Patient: 53 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: International Normalised Ratio Decreased, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammaplex

Other drugs received by patient: Pantoprazole; Phenoxymethylpenicillin; Ursodiol; Ramipril; Acetaminophen; Warfarin Sodium; Tramadol HCL; Fluticasone Proprionate Inhaler



Possible Gammaplex side effects in female

Reported by a pharmacist from United Kingdom on 2012-03-07

Patient: female

Reactions: International Normalised Ratio Decreased, Pulmonary Embolism, Drug Interaction

Drug(s) suspected as cause:
Gammaplex

Other drugs received by patient: Unknown; Warfarin Sodium



Possible Gammaplex side effects in 86 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-29

Patient: 86 year old female

Reactions: Back Pain, Fatigue, Activities of Daily Living Impaired

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Gammaplex
    Dosage: 25g iv
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2010-10-12

Gammaplex
    Indication: Blood Immunoglobulin A Decreased
    Start date: 2010-11-18

Gammaplex
    Indication: Blood Immunoglobulin G Decreased
    Start date: 2010-11-18

Other drugs received by patient: Penicillin; Codeine Phosphate; Morphine; Lactulose; Creon Tablet; Pravastatin; Scopolamine; Levemir; Novorapid; Loperamide HCL; Calcichew (D3 Forte); Peppermint Tablets



Possible Gammaplex side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-07-05

Patient: 56 year old female, weighing 84.0 kg (184.8 pounds)

Reactions: Chest Discomfort, Chest Pain, Tachycardia, Headache, Hypertension, Rash Pruritic, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammaplex
    Dosage: 30g
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2010-09-06

Symbicort

Captopril

Ezetimibe

Other drugs received by patient: Bendroflumethazide; Metformin HCL; Insulin; Gliclazide



Possible Gammaplex side effects in 18 year old female

Reported by a physician from India on 2011-07-05

Patient: 18 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Abdominal Pain, Vomiting, Headache, Pyrexia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Prednisolone
    Dosage: 7.5 mg
    Administration route: Oral

Gammaplex
    Dosage: 1000mg/kg
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-05-24



Possible Gammaplex side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-07-05

Patient: 69 year old female, weighing 93.1 kg (204.8 pounds)

Reactions: Respiratory Rate Increased, Heart Rate Increased, Chills, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gammaplex

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