DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Azulfidine (Sulfasalazine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Azulfidine (Sulfasalazine) 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 (188)
Death (16)
Life Threatening Events (20)
Disability (1)

Reports by Reaction Type

Drug Eruption (12)Drug Rash With Eosinophilia and Systemic Symptoms (11)Agranulocytosis (11)Hepatic Function Abnormal (10)Liver Disorder (10)Histiocytosis Haematophagic (10)Pyrexia (9)Interstitial Lung Disease (9)Pneumonia (9)Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis (9)Malaise (8)Toxic Skin Eruption (8)

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

Possible Azulfidine side effects in 81 year old female

Reported by a pharmacist from Japan on 2012-08-20

Patient: 81 year old female

Reactions: Oculomucocutaneous Syndrome

Drug(s) suspected as cause:
Azulfidine

Other drugs received by patient: Zolpidem; Celebrex



Possible Azulfidine side effects in 88 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 88 year old female

Reactions: Cardiac Failure, Heparin-Induced Thrombocytopenia, Renal Failure Chronic, Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    End date: 2011-11-07

Heparin
    Dosage: unk



Possible Azulfidine side effects in 49 year old female

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

Patient: 49 year old female

Reactions: Rheumatoid Arthritis, Impaired Work Ability, Synovitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Azulfidine
    Dosage: 1000 mg, 2x/day (2 tabs am, 2 tabs pm)

Effexor XR
    Dosage: 150 mg, daily

Other drugs received by patient: Requip; Naproxen Sodium



Possible Azulfidine side effects in 57 year old female

Reported by a physician from Germany on 2012-08-10

Patient: 57 year old female

Reactions: Raynaud's Phenomenon

Drug(s) suspected as cause:
Azulfidine
    Dosage: 2 tablets twice daily

Azulfidine
    Dosage: 2 tablets three times daily



Possible Azulfidine side effects in 64 year old female

Reported by a physician from Japan on 2012-08-08

Patient: 64 year old female, weighing 54.5 kg (119.9 pounds)

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Start date: 2007-04-04
    End date: 2012-03-04

Enbrel
    Dosage: 25 mg, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2007-06-16
    End date: 2007-07-27

Enbrel
    Dosage: 25 mg, 2x/week
    Start date: 2008-08-09
    End date: 2011-11-20

Enbrel
    Dosage: unk
    End date: 2012-06-20

Enbrel
    Dosage: 25 mg, weekly
    Start date: 2007-07-28
    End date: 2008-01-18

Enbrel
    Dosage: 25 mg, 2x/week
    Start date: 2008-01-19
    End date: 2008-08-08

Enbrel
    Dosage: 50 mg, weekly
    Start date: 2011-11-21
    End date: 2012-06-19

Rheumatrex
    Dosage: 6 mg, weekly
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2007-04-04
    End date: 2007-07-27

Rheumatrex
    Dosage: 8 mg, weekly
    Administration route: Oral
    Start date: 2009-01-09
    End date: 2012-01-15

Rheumatrex
    Dosage: 8 mg, weekly
    Administration route: Oral
    Start date: 2007-07-28
    End date: 2007-10-26

Rheumatrex
    Dosage: 6 mg, weekly
    Administration route: Oral
    Start date: 2007-10-27
    End date: 2009-01-08

Rheumatrex
    Dosage: 10 mg, weekly
    Administration route: Oral
    Start date: 2012-01-16
    End date: 2012-06-19

Other drugs received by patient: Folic Acid; Risedronate Sodium



Possible Azulfidine side effects in 63 year old female

Reported by a physician from Japan on 2012-08-08

Patient: 63 year old female

Reactions: Granulocytopenia

Drug(s) suspected as cause:
Azulfidine

Other drugs received by patient: Depas



Possible Azulfidine side effects in

Reported by a physician from Japan on 2012-08-07

Patient:

Reactions: Malaise, Pyrexia, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine



Possible Azulfidine side effects in 37 year old male

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

Patient: 37 year old male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Azulfidine
    Dosage: unk

Celexa
    Dosage: unk

Ddavp
    Dosage: unk

Desmopressin Acetate
    Dosage: unk

Protonix
    Dosage: unk



Possible Azulfidine side effects in 68 year old male

Reported by a physician from Japan on 2012-08-03

Patient: 68 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Drug Eruption, Asthma, Respiratory Failure, Drug Hypersensitivity, Platelet Count Decreased, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine

Other drugs received by patient: Lansoprazole; Acetaminophen; Loxonin



Possible Azulfidine side effects in 68 year old female

Reported by a pharmacist from Japan on 2012-08-02

Patient: 68 year old female, weighing 52.1 kg (114.6 pounds)

Reactions: Granulocytopenia, Erythema, Toxic Skin Eruption, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine



Possible Azulfidine side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-07-31

Patient: 60 year old female

Reactions: Pericarditis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 1000 (unit not provided)/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16

Bredinin
    Dosage: unk
    Administration route: Oral

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16

Mucosta
    Dosage: 200 mg, 1x/day
    Start date: 2011-06-01
    End date: 2011-06-16

Rheumatrex
    Dosage: 6 mg, weekly
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16



Possible Azulfidine side effects in 68 year old male

Reported by a physician from Japan on 2012-07-30

Patient: 68 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Asthma, Drug Eruption, Respiratory Failure, Platelet Count Decreased, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine

Other drugs received by patient: Loxonin; Lansoprazole; Acetaminophen



Possible Azulfidine side effects in 75 year old male

Reported by a pharmacist from Japan on 2012-07-30

Patient: 75 year old male

Reactions: Large Intestine Carcinoma

Drug(s) suspected as cause:
Azulfidine
    Dosage: 2 df, unk
    Indication: Rheumatoid Arthritis

Rheumatrex
    Dosage: 10 mg, weekly
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Folic Acid



Possible Azulfidine side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-07-27

Patient: 60 year old female

Reactions: Pericarditis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 1000 (unit not provided)/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16

Bredinin
    Dosage: unk
    Administration route: Oral

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16

Mucosta
    Dosage: 200 mg, 1x/day
    Start date: 2011-06-01
    End date: 2011-06-16

Rheumatrex
    Dosage: 6 mg, weekly
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16



Possible Azulfidine side effects in 61 year old female

Reported by a physician from Japan on 2012-07-26

Patient: 61 year old female

Reactions: Leukaemia, Generalised Erythema, Asthenia

Drug(s) suspected as cause:
Azulfidine

Other drugs received by patient: Farnezone; Mover



Possible Azulfidine side effects in 68 year old male

Reported by a physician from Japan on 2012-07-25

Patient: 68 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Asthma, Drug Eruption, Respiratory Failure, Platelet Count Decreased, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine

Other drugs received by patient: Acetaminophen; Lansoprazole; Loxonin



Possible Azulfidine side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient: male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Azulfidine
    Dosage: unk

Celexa
    Dosage: unk

Ddavp
    Dosage: unk

Desmopressin Acetate
    Dosage: unk

Protonix
    Dosage: unk



Possible Azulfidine side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-07-24

Patient: 60 year old female

Reactions: Pericarditis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 1000, unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16

Rheumatrex
    Dosage: 6 mg, weekly
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-06-01
    End date: 2011-06-16

Other drugs received by patient: Mucosta; Celecoxib



Possible Azulfidine side effects in 85 year old female

Reported by a physician from Japan on 2012-07-24

Patient: 85 year old female

Reactions: Heparin-Induced Thrombocytopenia, Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Azulfidine



Possible Azulfidine side effects in 83 year old female

Reported by a physician from Japan on 2012-07-23

Patient: 83 year old female

Reactions: Rheumatoid Arthritis, Joint Effusion

Drug(s) suspected as cause:
Azulfidine

Other drugs received by patient: Celebrex



Possible Azulfidine side effects in 33 year old female

Reported by a consumer/non-health professional from Japan on 2012-07-23

Patient: 33 year old female

Reactions: Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis

Drug(s) suspected as cause:
Azulfidine



Possible Azulfidine side effects in 50 year old male

Reported by a physician from Hungary on 2012-07-23

Patient: 50 year old male

Reactions: Pancreatitis Acute, Pancreatic Pseudocyst

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Indication: Ankylosing Spondylitis

Remicade
    Indication: Ankylosing Spondylitis

Other drugs received by patient: Fenofibrate; Ezetimibe; Atorvastatin



Possible Azulfidine side effects in

Reported by a pharmacist from Japan on 2012-07-19

Patient:

Reactions: Oculomucocutaneous Syndrome

Drug(s) suspected as cause:
Azulfidine



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 60 year old female

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

Patient: 60 year old female

Reactions: Pericarditis

Drug(s) suspected as cause:
Azulfidine
    Dosage: unk

Celebrex
    Dosage: unk
    Administration route: Oral

Mucosta
    Dosage: unk

Rheumatrex
    Dosage: unk
    Administration route: Oral



Possible Azulfidine side effects in

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

Patient:

Reactions: Malaise, Rash, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine



Possible Azulfidine side effects in 67 year old male

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

Patient: 67 year old male

Reactions: Drug Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2012-04-23
    End date: 2012-05-06

Azulfidine
    Dosage: 500mg tabs, 2 tabs/day
    Administration route: Oral
    Start date: 2012-05-07
    End date: 2012-05-08

Other drugs received by patient: Cytotec; Uralyt-U; Prednisolone; Celebrex; Urinorm; Rimatil



Possible Azulfidine side effects in male

Reported by a pharmacist from United States on 2012-07-18

Patient: male

Reactions: Malaise

Drug(s) suspected as cause:
Azulfidine



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 50 year old male

Reported by a physician from Hungary on 2012-07-16

Patient: 50 year old male

Reactions: Pancreatitis Acute, Pancreatic Pseudocyst

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azulfidine
    Indication: Ankylosing Spondylitis

Remicade
    Indication: Ankylosing Spondylitis

Other drugs received by patient: Fenofibrate; Ezetimibe; Atorvastatin

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017