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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 39 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-08
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: 1 mg, 1x/day
Administration route: Oral
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
Sulfasalazine
Dosage: 3 df, 1x/day
Administration route: Oral
Sulfasalazine
Dosage: 2 df, 1x/day
Administration route: Oral
Sulfasalazine
Dosage: 4 df, 1x/day
Administration route: Oral
End date: 2012-06-04
Sulfasalazine
Dosage: 1 df, 1x/day
Administration route: Oral
Indication: Arthralgia
Start date: 2012-04-18
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