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Azulfidine (Sulfasalazine) - Agranulocytosis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Agranulocytosis (11)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Azulfidine (Sulfasalazine) where reactions include agranulocytosis. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Azulfidine side effects in male

Reported by a physician from Japan on 2012-07-18

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Agranulocytosis, Histiocytosis Haematophagic, Pseudomonal Sepsis, Disseminated Intravascular Coagulation, Cytomegalovirus Infection, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 1000 mg, 1x/day
    Administration route: Oral
    Indication: Sjogren's Syndrome
    Start date: 2012-03-29
    End date: 2012-04-17

Azulfidine
    Indication: Arthropathy

Azulfidine
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Scleroderma
    Start date: 2012-03-14
    End date: 2012-03-28

Other drugs received by patient: Actos; Rabeprazole Sodium; Lobu; Prednisolone



Possible Azulfidine side effects in 59 year old female

Reported by a pharmacist from Japan on 2012-07-16

Patient: 59 year old female, weighing 64.8 kg (142.6 pounds)

Reactions: Drug Eruption, Hepatic Function Abnormal, Oesophagitis Ulcerative, Febrile Neutropenia, Agranulocytosis, RED Blood Cell Count Decreased, Arthralgia, Oral Candidiasis, Herpes Oesophagitis, Abscess Limb

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-05

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-04

Other drugs received by patient: Prednisolone; Prednisolone



Possible Azulfidine side effects in 59 year old female

Reported by a pharmacist from Japan on 2012-07-05

Patient: 59 year old female, weighing 64.8 kg (142.6 pounds)

Reactions: Drug Eruption, Hepatic Function Abnormal, Febrile Neutropenia, Oesophagitis Ulcerative, Agranulocytosis, Oral Candidiasis, RED Blood Cell Count Decreased, Arthralgia, Herpes Oesophagitis, Abscess Limb

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-05

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-04

Other drugs received by patient: Prednisolone Sodium Succinate INJ; Prednisolone Sodium Succinate INJ



Possible Azulfidine side effects in 59 year old female

Reported by a physician from Japan on 2012-06-04

Patient: 59 year old female, weighing 64.8 kg (142.6 pounds)

Reactions: Drug Eruption, Hepatic Function Abnormal, Febrile Neutropenia, Oesophagitis Ulcerative, Agranulocytosis, Oral Candidiasis, Arthralgia, RED Blood Cell Count Decreased, Herpes Oesophagitis, Abscess Limb

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-05

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-04

Other drugs received by patient: Prednisolone; Prednisolone



Possible Azulfidine side effects in 59 year old female

Reported by a pharmacist from Japan on 2012-05-25

Patient: 59 year old female, weighing 64.8 kg (142.6 pounds)

Reactions: Drug Eruption, Hepatic Function Abnormal, Effusion, Oesophagitis Ulcerative, Oropharyngeal Pain, Malaise, RED Blood Cell Count Decreased, Gamma-Glutamyltransferase Increased, Oral Candidiasis, Abscess Limb, Blood Alkaline Phosphatase Increased, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Febrile Neutropenia, Agranulocytosis, Arthralgia, Aspartate Aminotransferase Increased, Herpes Oesophagitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-05

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-10-01
    End date: 2011-11-04

Other drugs received by patient: Prednisolone; Prednisolone



Possible Azulfidine side effects in 66 year old male

Reported by a physician from Japan on 2012-05-15

Patient: 66 year old male, weighing 69.0 kg (151.8 pounds)

Reactions: Agranulocytosis, Pyelonephritis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2012-01-12
    End date: 2012-02-23

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Start date: 2012-01-12
    End date: 2012-02-23

Other drugs received by patient: Amlodipine; Rebamipide; Famotidine; Propiverine Hydrochloride; Glimepiride; Loxonin; Pursennid; Sitagliptin Phosphate; Azelastine Hydrochloride



Possible Azulfidine side effects in 60 year old male

Reported by a physician from Japan on 2012-04-30

Patient: 60 year old male

Reactions: Agranulocytosis, Disseminated Intravascular Coagulation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Indication: Sjogren's Syndrome

Azulfidine
    Indication: Arthropathy

Azulfidine
    Dosage: 1 g/day
    Administration route: Oral
    Indication: Scleroderma
    Start date: 2012-03-14



Possible Azulfidine side effects in 66 year old male

Reported by a physician from Japan on 2012-04-27

Patient: 66 year old male, weighing 69.0 kg (151.8 pounds)

Reactions: Agranulocytosis, Pyelonephritis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Start date: 2012-01-12
    End date: 2012-02-23

Azulfidine
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2012-01-12
    End date: 2012-02-23

Other drugs received by patient: Propiverine Hydrochloride; Glimepiride; Azelastine Hydrochloride; Pursennid; Rebamipide; Amlodipine; Famotidine; Sitagliptin Phosphate; Loxonin



Possible Azulfidine side effects in 78 year old male

Reported by a physician from Japan on 2011-10-28

Patient: 78 year old male

Reactions: Agranulocytosis, Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Azulfidine



Possible Azulfidine side effects in 78 year old male

Reported by a physician from Japan on 2011-10-11

Patient: 78 year old male

Reactions: Agranulocytosis, Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Azulfidine



Possible Azulfidine side effects in 78 year old male

Reported by a physician from Japan on 2011-10-11

Patient: 78 year old male, weighing 60.2 kg (132.4 pounds)

Reactions: Disseminated Intravascular Coagulation, Oropharyngeal Pain, Pyrexia, Chest X-RAY Abnormal, Agranulocytosis, Corynebacterium Test Positive, Sepsis, Septic Shock, Leukopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg daily
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2010-03-04

Azulfidine
    Dosage: 500 mg, 2x/day
    Start date: 2010-03-11
    End date: 2010-04-19

Other drugs received by patient: Olmesartan Medoxomil; Calblock; Insulin Detemir; Aspirin; Lansoprazole; Glufast; Montelukast Sodium; Alendronate Sodium; Prednisolone

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