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Sulfasalazine Side Effects

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Common Sulfasalazine Side Effects


The most commonly reported Sulfasalazine side effects (click to view or check a box to report):

Pyrexia (106)
Rash (62)
Headache (60)
Nausea (51)
Lymphadenopathy (41)
Diarrhoea (40)
Neutropenia (40)
Dyspnoea (37)
Fatigue (37)
Malaise (33)
Cough (30)
Hypersensitivity (29)
Arthralgia (29)
Agranulocytosis (27)
Interstitial Lung Disease (27)
Vomiting (25)
Pruritus (24)
Alanine Aminotransferase Increased (24)
Anaemia (24)
Hepatitis (23)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Sulfasalazine Side Effects Reported to FDA



Sulfasalazine Side Effect Report#9999812
Rash, Liver Function Test Abnormal, Neutropenic Sepsis, Hepatitis
This is a report of a 40-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Sulfasalazine (dosage: NA, start time: NS), combined with:
  • 6-mercaptopurine (Unk)
  • Pentasa (Unk)
  • Co-codamol (Unk)
  • Difflam (Unk (spray))
  • Penicillin V (Unk)
and developed a serious reaction and side effect(s): Rash, Liver Function Test Abnormal, Neutropenic Sepsis, Hepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in male patients, resulting in Rash side effect. The patient was hospitalized.
Sulfasalazine Side Effect Report#9994560
Pulmonary Embolism
This report suggests a potential Sulfasalazine Pulmonary Embolism side effect(s) that can have serious consequences. A 42-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: arthritis reactive and used Sulfasalazine (dosage: 1 G, 2x/day) starting
Jan 01, 1990. After starting Sulfasalazine the patient began experiencing various side effects, including: Pulmonary EmbolismAdditional drugs used concurrently:
  • Tinzaparin (Unk)
  • Warfarin (Unk)
The patient was hospitalized. Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Embolism, may still occur.
Sulfasalazine Side Effect Report#9973013
Lupus-like Syndrome, Cerebral Infarction
This Lupus-like Syndrome problem was reported by a health professional from US. A 19-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On NS this consumer started treatment with Sulfasalazine (dosage: 1.5 G, Daily). The following drugs were being taken at the same time: NA. When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Lupus-like Syndrome, Cerebral InfarctionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lupus-like Syndrome, may become evident only after a product is in use by the general population.
Sulfasalazine Side Effect Report#9973012
Cerebral Infarction, Hemiparesis, Hypersensitivity, Headache, Pyrexia
This Cerebral Infarction side effect was reported by a physician from US. A 13-year-old female patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Sulfasalazine (drug dosage: 1.5 G, Daily), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Cerebral Infarction, Hemiparesis, Hypersensitivity, Headache, PyrexiaThese side effects may potentially be related to Sulfasalazine.
Sulfasalazine Side Effect Report#9973001
Ataxia, Peripheral Sensory Neuropathy, Neurotoxicity
This is a report of a 73-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Sulfasalazine (dosage: 3 G, Daily, start time: NS), combined with:
  • Prednisone (Unk)
and developed a serious reaction and side effect(s): Ataxia, Peripheral Sensory Neuropathy, Neurotoxicity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in male patients, resulting in Ataxia side effect. The patient was hospitalized.
Sulfasalazine Side Effect Report#9972998
Peripheral Sensorimotor Neuropathy, Paraparesis, Paraesthesia, Muscular Weakness, Ataxia
This report suggests a potential Sulfasalazine Peripheral Sensorimotor Neuropathy side effect(s) that can have serious consequences. A 63-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colitis ulcerative and used Sulfasalazine (dosage: 1 G, 1x/day) starting NS. After starting Sulfasalazine the patient began experiencing various side effects, including: Peripheral Sensorimotor Neuropathy, Paraparesis, Paraesthesia, Muscular Weakness, AtaxiaAdditional drugs used concurrently:
  • Prednisolone (60 Mg, Alternate Day)
  • Prednisolone (15 Mg, Alternate Day)
  • Prednisolone (10 Mg, Alternate Day)
  • Prednisolone (7.5 Mg, Alternate Day)
  • Prednisolone (Unk)
  • Ferrous Sulphate (Unk)
The patient was hospitalized. Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Peripheral Sensorimotor Neuropathy, may still occur.
Sulfasalazine Side Effect Report#9972312
Leukoplakia Oral, Glossitis, Stomatitis
This Leukoplakia Oral problem was reported by a consumer or non-health professional from DE. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatic disorder. On 2009 this consumer started treatment with Sulfasalazine (dosage: Unk). The following drugs were being taken at the same time: NA. When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Leukoplakia Oral, Glossitis, StomatitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Leukoplakia Oral, may become evident only after a product is in use by the general population.
Sulfasalazine Side Effect Report#9922824
Meningitis Aseptic, Pain In Extremity, Hypersensitivity, Rash Macular
This Meningitis Aseptic side effect was reported by a health professional from TN. A 37-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Sulfasalazine (drug dosage: 0.5 G, Daily), which was initiated on 1989. Concurrently used drugs: NA..After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Meningitis Aseptic, Pain In Extremity, Hypersensitivity, Rash MacularThese side effects may potentially be related to Sulfasalazine. The patient was hospitalized.
Sulfasalazine Side Effect Report#9922318
Activities Of Daily Living Impaired, Interstitial Lung Disease, Gait Disturbance
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis, who was treated with Sulfasalazine (dosage: 2 Tablets 4 Times A Day By Mouth, start time: 1980), combined with:
  • Omeprazole
  • Potassium
  • Loprazolam
  • Simvastatin
  • Setraline
  • Furosemide
  • Fish Oil
and developed a serious reaction and side effect(s): Activities Of Daily Living Impaired, Interstitial Lung Disease, Gait Disturbance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in female patients, resulting in Activities Of Daily Living Impaired side effect.
Sulfasalazine Side Effect Report#9921705
Meningitis Aseptic, Hypersensitivity, Rash Maculo-papular, Transaminases Increased, Oedema
This report suggests a potential Sulfasalazine Meningitis Aseptic side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from TN was diagnosed with the following symptoms/conditions: synovitis and used Sulfasalazine (dosage: 500 Mg, Daily) starting NS. After starting Sulfasalazine the patient began experiencing various side effects, including: Meningitis Aseptic, Hypersensitivity, Rash Maculo-papular, Transaminases Increased, OedemaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Meningitis Aseptic, may still occur.
Sulfasalazine Side Effect Report#9921699
Meningitis Aseptic
This Meningitis Aseptic problem was reported by a health professional from TN. A 41-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On NS this consumer started treatment with Sulfasalazine (dosage: 500 Mg, 2x/day). The following drugs were being taken at the same time:
  • Prednisone (10 Mg, Daily)
When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Meningitis AsepticThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Meningitis Aseptic, may become evident only after a product is in use by the general population.
Sulfasalazine Side Effect Report#9921694
Meningitis Aseptic
This Meningitis Aseptic side effect was reported by a health professional from TN. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: ankylosing spondylitis.The patient was prescribed Sulfasalazine (drug dosage: 2 G, Daily), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Meningitis AsepticThese side effects may potentially be related to Sulfasalazine. The patient was hospitalized.
Sulfasalazine Side Effect Report#9859675
Pulmonary Eosinophilia, Pulmonary Fibrosis
This is a report of a 58-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Sulfasalazine (dosage: 1 G, 3x/day, start time: 197409), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Eosinophilia, Pulmonary Fibrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in male patients, resulting in Pulmonary Eosinophilia side effect. The patient was hospitalized.
Sulfasalazine Side Effect Report#9859019
Lung Disorder, Eosinophilic Pneumonia
This report suggests a potential Sulfasalazine Lung Disorder side effect(s) that can have serious consequences. A 23-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: colitis ulcerative and used Sulfasalazine (dosage: Unk) starting NS. After starting Sulfasalazine the patient began experiencing various side effects, including: Lung Disorder, Eosinophilic PneumoniaAdditional drugs used concurrently:
  • Codeine Phosphate (Unk)
  • Ferrous Sulfate (Unk)
Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lung Disorder, may still occur.
Sulfasalazine Side Effect Report#9856094
Maternal Exposure During Pregnancy, Ureteric Stenosis, Pyelocaliectasis
This Maternal Exposure During Pregnancy problem was reported by a physician from DE. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On
Jul 03, 2009 this consumer started treatment with Sulfasalazine (dosage: 500 Mg, 2x/day). The following drugs were being taken at the same time:
  • Prednisolone (2.5 Mg, 1x/day)
  • Femibion (0.4 Mg, 1x/day)
When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Maternal Exposure During Pregnancy, Ureteric Stenosis, PyelocaliectasisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Maternal Exposure During Pregnancy, may become evident only after a product is in use by the general population.
Sulfasalazine Side Effect Report#9846217
Off Label Use, Coeliac Disease
This Off Label Use side effect was reported by a consumer or non-health professional from US. A 24-year-old female patient (weight:NA) experienced the following symptoms/conditions: psoriatic arthropathy.The patient was prescribed Sulfasalazine (drug dosage: 1000 Mg, 2x/day), which was initiated on
May 02, 2013. Concurrently used drugs: NA..After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Off Label Use, Coeliac DiseaseThese side effects may potentially be related to Sulfasalazine.
Sulfasalazine Side Effect Report#9845353
Influenza Like Illness, Rash, Pyrexia, Fatigue, Immobile, Product Substitution Issue, Economic Problem
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Sulfasalazine (dosage: NA, start time:
Dec 24, 2013), combined with: NA. and developed a serious reaction and side effect(s): Influenza Like Illness, Rash, Pyrexia, Fatigue, Immobile, Product Substitution Issue, Economic Problem after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in female patients, resulting in Influenza Like Illness side effect.
Sulfasalazine Side Effect Report#9831049
Encephalopathy, Meningitis, Pleurisy
This report suggests a potential Sulfasalazine Encephalopathy side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: rheumatoid arthritis and used Sulfasalazine (dosage: Unk) starting NS. After starting Sulfasalazine the patient began experiencing various side effects, including: Encephalopathy, Meningitis, PleurisyAdditional drugs used concurrently: NA. Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Encephalopathy, may still occur.
Sulfasalazine Side Effect Report#9818674
Pulmonary Fibrosis
This Pulmonary Fibrosis problem was reported by a pharmacist from GB. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On NS this consumer started treatment with Sulfasalazine (dosage: 2.5g Daily (1.5g In The Morning And 1g In The Evening)). The following drugs were being taken at the same time:
  • Methotrexate Sodium (20 Mg, Once Per Week (recently Increased))
  • Gabapentin (300 Mg, 3x/day)
  • Omeprazole (20 Mg, 1x/day)
  • Amitriptyline (150 Mg, Once Daily, At Night.)
  • Co-codamol (2 Df (30mg/500mg), Daily)
When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Pulmonary FibrosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Fibrosis, may become evident only after a product is in use by the general population.
Sulfasalazine Side Effect Report#9786590
Pulmonary Eosinophilia
This Pulmonary Eosinophilia side effect was reported by a health professional from DE. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Sulfasalazine (drug dosage: 3 G, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Pulmonary EosinophiliaThese side effects may potentially be related to Sulfasalazine.
Sulfasalazine Side Effect Report#9786588
Alveolitis, Interstitial Lung Disease
This is a report of a 59-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: mouth ulceration,pemphigoid, who was treated with Sulfasalazine (dosage: 1 G, Daily, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Alveolitis, Interstitial Lung Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in female patients, resulting in Alveolitis side effect.
Sulfasalazine Side Effect Report#9786563
Alveolitis Allergic
This report suggests a potential Sulfasalazine Alveolitis Allergic side effect(s) that can have serious consequences. A 40-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: inflammatory bowel disease and used Sulfasalazine (dosage: 500 Mg, 2x/day) starting NS. After starting Sulfasalazine the patient began experiencing various side effects, including: Alveolitis AllergicAdditional drugs used concurrently: NA. Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alveolitis Allergic, may still occur.
Sulfasalazine Side Effect Report#9786561
Interstitial Lung Disease, Pulmonary Fibrosis, Pneumonia
This Interstitial Lung Disease problem was reported by a health professional from DE. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: colitis ulcerative. On NS this consumer started treatment with Sulfasalazine (dosage: 4 G, Daily). The following drugs were being taken at the same time:
  • Prednisolone (Unk)
When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Interstitial Lung Disease, Pulmonary Fibrosis, PneumoniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Interstitial Lung Disease, may become evident only after a product is in use by the general population.
Sulfasalazine Side Effect Report#9786558
Interstitial Lung Disease, Pulmonary Fibrosis, Eosinophilia
This Interstitial Lung Disease side effect was reported by a health professional from DE. A 88-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Sulfasalazine (drug dosage: 2 G/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Interstitial Lung Disease, Pulmonary Fibrosis, EosinophiliaThese side effects may potentially be related to Sulfasalazine.
Sulfasalazine Side Effect Report#9786556
Interstitial Lung Disease, Lung Disorder
This is a report of a 72-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Sulfasalazine (dosage: 2 G, Daily, start time: NS), combined with:
  • Prednisone (40 Mg, Daily)
  • Prednisone (5 Mg, Daily)
and developed a serious reaction and side effect(s): Interstitial Lung Disease, Lung Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in male patients, resulting in Interstitial Lung Disease side effect. The patient was hospitalized.


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The appearance of Sulfasalazine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Sulfasalazine Side Effects for Women?

Women Side EffectsReports
Pyrexia 69
Headache 40
Rash 38
Nausea 33
Diarrhoea 27
Dyspnoea 25
Lymphadenopathy 25
Fatigue 24
Neutropenia 22
Pruritus 22

What are common Sulfasalazine Side Effects for Men?

Men Side EffectsReports
Pyrexia 36
Rash 24
Headache 20
Cough 19
Nausea 18
Lymphadenopathy 16
Neutropenia 16
Eosinophilia 15
Agranulocytosis 14
Malaise 14

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Sulfasalazine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Sulfasalazine Safety Alerts, Active Ingredients, Usage Information

    NDC0591-0796
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSulfasalazine
    NameSulfasalazine
    Dosage FormTABLET
    RouteORAL
    On market since19821001
    LabelerWatson Laboratories, Inc.
    Active Ingredient(s)SULFASALAZINE
    Strength(s)500
    Unit(s)mg/1
    Pharma ClassAminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient]

    Sulfasalazine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1103

    Sulfasalazine safety alerts: No

    Reported deaths: 76

    Reported hospitalizations: 601

    Latest Sulfasalazine clinical trials