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Sulfasalazine (Sulfasalazine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (459)
Death (19)
Life Threatening Events (62)
Disability (6)

Reports by Reaction Type

Drug Rash With Eosinophilia and Systemic Symptoms (39)Diarrhoea (38)Pyrexia (33)Rash (31)Abdominal Pain (30)Thrombocytopenia (30)Haematemesis (28)Contusion (25)Headache (25)Full Blood Count Abnormal (25)Nausea (22)Neutropenia (21)

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

Possible Sulfasalazine side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 63 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: LIP Blister, Hypersensitivity, Drug Ineffective, Joint Swelling, Oedema Peripheral, Anaphylactic Reaction, Drug Intolerance

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

Celebrex
    Dosage: 200 mg, 1x/day
    Indication: Joint Swelling
    Start date: 2012-07-03

Celebrex
    Indication: Arthritis

Celebrex
    Dosage: 200 mg, daily
    Indication: Oedema Peripheral
    Start date: 2012-02-01
    End date: 2012-01-01

Ibuprofen
    Indication: Oedema Peripheral

Ibuprofen
    Indication: Arthritis

Ibuprofen
    Dosage: unk
    Indication: Joint Swelling

Mobic
    Dosage: unk
    Indication: Oedema Peripheral

Mobic
    Indication: Arthritis

Mobic
    Indication: Joint Swelling

Naproxen (Aleve)
    Indication: Arthritis

Naproxen (Aleve)
    Indication: Joint Swelling

Naproxen (Aleve)
    Dosage: unk
    Indication: Oedema Peripheral

Plaquenil
    Indication: Joint Swelling

Plaquenil
    Indication: Arthritis

Plaquenil
    Dosage: unk
    Indication: Oedema Peripheral

Prednisone TAB
    Indication: Joint Swelling

Prednisone TAB
    Dosage: unk
    Indication: Oedema Peripheral

Sulfasalazine
    Dosage: unk
    Indication: Oedema Peripheral

Sulfasalazine
    Indication: Arthritis

Sulfasalazine
    Indication: Joint Swelling

Other drugs received by patient: Aspirin; Doxycycline; Methylprednisolone Acetate; Methylprednisolone Acetate; Methylprednisolone Acetate



Possible Sulfasalazine side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-24

Patient: 59 year old female, weighing 81.9 kg (180.2 pounds)

Reactions: Dyspnoea, Rash Generalised, Dysphagia, Swelling Face, Local Swelling

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Sulfasalazine

Other drugs received by patient: Acetaminophen and Codeine Phosphate; Omeprazole; Naproxen



Possible Sulfasalazine side effects in male

Reported by a physician from Germany on 2012-08-22

Patient: male

Reactions: Metastatic Bronchial Carcinoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Abatacept
    Indication: Polyarthritis
    Start date: 2007-12-01
    End date: 2008-06-01

Adalimumab
    Indication: Polyarthritis
    Start date: 2006-08-01
    End date: 2007-01-01

Anakinra
    Indication: Polyarthritis
    Start date: 2008-08-01
    End date: 2008-10-01

Certolizumab Pegol
    Indication: Polyarthritis
    Start date: 2011-09-01
    End date: 2011-10-01

Golimumab
    Indication: Polyarthritis
    Start date: 2011-03-01
    End date: 2011-08-01

Methotrexate
    Indication: Polyarthritis
    Start date: 2003-11-01
    End date: 2008-09-01

Methotrexate
    Start date: 2009-05-01

Roactemra
    Indication: Polyarthritis
    Start date: 2009-03-01
    End date: 2009-06-01

Sulfasalazine
    Indication: Polyarthritis
    Start date: 2009-07-01
    End date: 2011-03-01



Possible Sulfasalazine side effects in 58 year old female

Reported by a physician from Switzerland on 2012-08-21

Patient: 58 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Weight Increased, Respiratory Disorder, Alopecia, Tooth Disorder

Drug(s) suspected as cause:
Mefenamic Acid
    Dosage: 500 mg, as needed
    Administration route: Oral

Methotrexate Sodium
    Dosage: 20 mg, as needed
    Indication: Rheumatoid Arthritis
    Start date: 2011-04-13
    End date: 2011-05-07

Prednisolone
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Start date: 2011-05-07
    End date: 2011-05-10

Sulfasalazine
    Dosage: 2 g, 1x/day
    Administration route: Oral
    Start date: 2011-05-11
    End date: 2011-09-07

Other drugs received by patient: Voltaflex Plus; Condrosulf



Possible Sulfasalazine side effects in 60 year old female

Reported by a physician from Switzerland on 2012-08-20

Patient: 60 year old female

Reactions: Hepatocellular Injury, Transaminases Increased, Hypoplastic Anaemia

Drug(s) suspected as cause:
Sulfasalazine
    Dosage: 2 g, 1x/day
    Administration route: Oral
    Start date: 2012-04-16
    End date: 2012-05-11

Sulfasalazine
    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Polyarthritis
    Start date: 2012-03-09

Other drugs received by patient: Pantoprazole; Mefenacid



Possible Sulfasalazine side effects in male

Reported by a physician from Germany on 2012-08-20

Patient: male

Reactions: Metastases To Liver, Metastatic Bronchial Carcinoma, Malignant Neoplasm of Pleura

Adverse event resulted in: death

Drug(s) suspected as cause:
Abatacept
    Indication: Polyarthritis
    Start date: 2007-12-01
    End date: 2008-06-01

Anakinra
    Indication: Polyarthritis
    Start date: 2008-08-01
    End date: 2008-10-01

Certolizumab Pegol
    Dosage: cumulative dose: 200 mg
    Indication: Polyarthritis
    Start date: 2011-09-01
    End date: 2011-10-01

Golimumab
    Indication: Polyarthritis
    Start date: 2011-03-01
    End date: 2011-08-01

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2006-08-01
    End date: 2007-01-01

Methotrexate
    Indication: Polyarthritis
    Start date: 2003-11-01
    End date: 2008-09-01

Methotrexate
    Start date: 2009-05-01

Sulfasalazine
    Indication: Polyarthritis
    Start date: 2009-07-01
    End date: 2011-03-01

Tocilizumab
    Indication: Polyarthritis
    Start date: 2009-03-01
    End date: 2009-06-01

Other drugs received by patient: Methotrexate; Abatacept; Tocilizumab; Sulfasalazine; Methotrexate; Certolizumab; Golimumab; Anakinra



Possible Sulfasalazine side effects in 61 year old female

Reported by a consumer/non-health professional from Finland on 2012-08-20

Patient: 61 year old female

Reactions: Pneumonia, Mouth Haemorrhage, Skin Exfoliation, DRY Skin, Skin Haemorrhage, Onychoclasis, Melanocytic Naevus, Tooth Disorder

Drug(s) suspected as cause:
Sulfasalazine

Other drugs received by patient: Nuelin Depot; Fluticasone Propionate / Salmeterol; Forteo; Panacod; Gasterix; Calcium Carbonate; Prednisolone; Spiriva



Possible Sulfasalazine side effects in 70 year old female

Reported by a physician from Indonesia on 2012-08-17

Patient: 70 year old female

Reactions: Mouth Haemorrhage, Chapped Lips, Mouth Ulceration, Drug Hypersensitivity, Rash, Odynophagia, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-20
    End date: 2012-07-25

Sulfasalazine
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Spondylitis
    Start date: 2012-07-20
    End date: 2012-07-23



Possible Sulfasalazine side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Abdominal Pain, Weight Decreased, Dyspnoea, Lung Infection, Abdominal Pain Upper, Injection Site Pruritus, Pericardial Effusion, Abdominal Discomfort, Fatigue, Injection Site Erythema, Gastrointestinal Pain, Diarrhoea, Dyspepsia, Tooth Disorder

Adverse event resulted in: hospitalization

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

Enbrel
    Indication: Ankylosing Spondylitis

Mobic
    Indication: Back Pain

Mobic
    Dosage: 15 mg
    Administration route: Oral
    Indication: Sciatica
    Start date: 2011-08-28
    End date: 2011-09-06

Naprosyn
    Dosage: 1000 mg

Naprosyn

Piroxicam

Sulfasalazine
    Indication: Ankylosing Spondylitis

Other drugs received by patient: Tramadol HCL



Possible Sulfasalazine side effects in 86 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17

Patient: 86 year old female

Reactions: Rheumatoid Arthritis, Rash, Erythema Multiforme, Dermatitis Exfoliative, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2007-01-01
    End date: 2010-12-13

Sulfasalazine
    Dosage: 2 df, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2007-07-01
    End date: 2010-12-03

Other drugs received by patient: Micardis; Tramadol HCL; Acetaminophen; Cacit D3; Clonazepam; Oxybutynin; Prednisone TAB; Tramadol HCL; Efferalgan / 00020001 /; Fosamax; Ferrous Sulfate TAB



Possible Sulfasalazine side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17

Patient: 39 year old female

Reactions: Myalgia, Hypersensitivity, Arthralgia, Oedema Peripheral, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Plaquenil
    Dosage: 2 df, 1x/day
    Administration route: Oral
    Indication: Systemic Lupus Erythematosus
    Start date: 2006-01-01

Prednisone TAB
    Dosage: 5 mg per day initially, and at 1 mg/day after sulfalsalazine institution
    Administration route: Oral
    Indication: Systemic Lupus Erythematosus
    Start date: 2006-01-01

Prednisone TAB
    Dosage: 1 mg, 1x/day
    Administration route: Oral

Sulfasalazine
    Dosage: 3 df, 1x/day
    Administration route: Oral

Sulfasalazine
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2012-04-18

Sulfasalazine
    Dosage: 2 df, 1x/day
    Administration route: Oral

Sulfasalazine
    Dosage: 4 df, 1x/day
    Administration route: Oral
    End date: 2012-06-01



Possible Sulfasalazine side effects in 83 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17

Patient: 83 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Dermatitis Exfoliative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omeprazole
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Sulfasalazine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Sulfasalazine side effects in 88 year old female

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

Patient: 88 year old female

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

Adverse event resulted in: death

Drug(s) suspected as cause:
Sulfasalazine



Possible Sulfasalazine side effects in male

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

Patient: male

Reactions: Metastases To Liver, Metastatic Bronchial Carcinoma, Malignant Neoplasm of Pleura

Adverse event resulted in: death

Drug(s) suspected as cause:
Abatacept
    Indication: Polyarthritis
    Start date: 2007-12-01
    End date: 2008-06-01

Anakinra
    Indication: Polyarthritis
    Start date: 2008-08-01
    End date: 2008-10-01

Cimzia
    Dosage: cumulative dose: 200 mg
    Indication: Polyarthritis
    Start date: 2011-09-01
    End date: 2011-10-01

Golimumab
    Indication: Polyarthritis
    Start date: 2011-03-01
    End date: 2011-08-01

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2006-08-01
    End date: 2007-01-01

Methotrexate
    Indication: Polyarthritis
    Start date: 2003-11-01

Sulfasalazine
    Indication: Polyarthritis
    Start date: 2009-07-01
    End date: 2011-03-01

Tocilizumab
    Indication: Polyarthritis
    Start date: 2009-03-01
    End date: 2009-06-01

Other drugs received by patient: Sulfasalazine; Methotrexate; Anakinra; Abatacept; Golimumab; Methotrexate; Tocilizumab; Certolizumab



Possible Sulfasalazine side effects in 83 year old male

Reported by a pharmacist from United Kingdom on 2012-08-16

Patient: 83 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Dermatitis Exfoliative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omeprazole
    Indication: Product Used FOR Unknown Indication

Sulfasalazine
    Indication: Product Used FOR Unknown Indication



Possible Sulfasalazine side effects in 53 year old female

Reported by a individual with unspecified qualification from Turkey on 2012-08-16

Patient: 53 year old female

Reactions: Drug Ineffective, Cervix Carcinoma

Drug(s) suspected as cause:
Etanercept
    Dosage: 25 mg was started at 2 injections per week
    Start date: 2007-04-01

Etanercept
    Dosage: unk
    Indication: Ankylosing Spondylitis

Sulfasalazine
    Dosage: unk
    Indication: Ankylosing Spondylitis

Sulfasalazine
    Dosage: unk
    Start date: 2010-04-01



Possible Sulfasalazine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

Reactions: Drug Ineffective, Product Odour Abnormal

Drug(s) suspected as cause:
Sulfasalazine



Possible Sulfasalazine side effects in female

Reported by a health professional (non-physician/pharmacist) from Norway on 2012-08-15

Patient: female

Reactions: Neutropenia

Drug(s) suspected as cause:
Azathioprine Sodium
    Indication: Leukopenia

Azathioprine Sodium
    Indication: Juvenile Arthritis

Chloroquine
    Indication: Juvenile Arthritis

Chloroquine HCL
    Indication: Juvenile Arthritis

Etanercept
    Indication: Juvenile Arthritis

Gold
    Indication: Juvenile Arthritis

Mabthera
    Dosage: given after 5 months from the event
    Start date: 2008-01-01

Mabthera
    Indication: Rheumatoid Arthritis
    Start date: 2008-06-01

Methotrexate Sodium
    Dosage: treatment after rituximab

Methotrexate Sodium
    Dosage: prevoius treatment before rituximab
    Indication: Juvenile Arthritis

Sulfasalazine
    Indication: Juvenile Arthritis

Other drugs received by patient: Prednisolone



Possible Sulfasalazine side effects in 86 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 86 year old female

Reactions: Rheumatoid Arthritis, Rash, Dermatitis Exfoliative, Erythema Multiforme, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2007-01-01
    End date: 2010-12-13

Sulfasalazine
    Dosage: 2 df, 2x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2007-07-01
    End date: 2010-12-03

Other drugs received by patient: Fosamax; Ferrous Sulfate TAB; Acetaminophen; Clonazepam; Cacit D3; Prednisone; Tramadol HCL; Oxybutynin; Micardis



Possible Sulfasalazine side effects in 53 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-14

Patient: 53 year old female

Reactions: Drug Ineffective, Cervix Carcinoma

Drug(s) suspected as cause:
Etanercept
    Dosage: 25 mg was started at 2 injections per week
    Indication: Ankylosing Spondylitis
    Start date: 2007-04-01

Sulfasalazine
    Dosage: unk
    Indication: Ankylosing Spondylitis

Sulfasalazine
    Dosage: unk
    Start date: 2010-04-01



Possible Sulfasalazine side effects in 52 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-14

Patient: 52 year old female

Reactions: White Blood Cell Count Abnormal

Drug(s) suspected as cause:
Sulfasalazine



Possible Sulfasalazine side effects in 43 year old female

Reported by a pharmacist from Japan on 2012-08-14

Patient: 43 year old female

Reactions: Haemorrhage

Drug(s) suspected as cause:
Sulfasalazine



Possible Sulfasalazine side effects in 42 year old male

Reported by a physician from Germany on 2012-08-13

Patient: 42 year old male

Reactions: Sarcoidosis, Nephritis

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

Adalimumab

Ibuprofen
    Indication: Ankylosing Spondylitis

Sulfasalazine
    Indication: Ankylosing Spondylitis



Possible Sulfasalazine side effects in 26 year old male

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

Patient: 26 year old male

Reactions: Metabolic Acidosis, Hypothermia, Coagulopathy, Lactic Acidosis, Respiratory Depression, Toxicity To Various Agents, Muscle Twitching, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Feverall
    Dosage: 50 g; po
    Administration route: Oral

Sulfasalazine
    Dosage: 50 gr;po
    Administration route: Oral
    Indication: Ankylosing Spondylitis



Possible Sulfasalazine side effects in 50 year old female

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

Patient: 50 year old female

Reactions: Rheumatoid Arthritis

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, qwk
    Indication: Rheumatoid Arthritis
    Start date: 2005-01-01

Plaquenil
    Dosage: unk

Sulfasalazine
    Dosage: unk

Other drugs received by patient: Methotrexate Sodium



Possible Sulfasalazine side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient: 51 year old female

Reactions: Cytolytic Hepatitis, Cholestasis, Hypergammaglobulinaemia, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulfasalazine

Other drugs received by patient: Acetaminophen; Omeprazole; Ketoprofen



Possible Sulfasalazine side effects in 33 year old female

Reported by a physician from United States on 2012-08-09

Patient: 33 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulfasalazine



Possible Sulfasalazine side effects in 83 year old male

Reported by a individual with unspecified qualification from United Kingdom on 2012-08-09

Patient: 83 year old male

Reactions: C-Reactive Protein Increased, Hyponatraemia, Dermatitis Exfoliative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omeprazole

Sulfasalazine



Possible Sulfasalazine side effects in 88 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 88 year old female

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

Adverse event resulted in: death

Drug(s) suspected as cause:
Sulfasalazine



Possible Sulfasalazine side effects in 70 year old female

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

Patient: 70 year old female

Reactions: Malabsorption, Gastrointestinal Haemorrhage, Chapped Lips, Rash, Odynophagia, Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-20

Sulfasalazine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-20

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