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Azathioprine Side Effects

PatientsVille

Common Azathioprine Side Effects


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

Pyrexia (117)
Pancytopenia (91)
Diarrhoea (75)
Nausea (72)
Fatigue (71)
Crohn's Disease (63)
Vomiting (60)
Dyspnoea (59)
Abdominal Pain (54)
Bone Marrow Failure (52)
Arthralgia (51)
Leukopenia (49)
Epstein-barr Virus Infection (49)
Asthenia (44)
Condition Aggravated (43)
Chills (41)
Pneumonia (41)
Headache (40)
Anaemia (40)
Histiocytosis Haematophagic (39)

➢ 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.

Azathioprine Side Effects Reported to FDA



Azathioprine Side Effect Report#9993507
Blood Creatine Phosphokinase Increased, Fatigue, Somnolence
This is a report of a 60-year-old male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: granulomatosis with polyangiitis,hyperuricaemia, who was treated with Azathioprine (dosage: Daily Dose: 50 Mg Millgram(s) Every Days, start time:
Nov 03, 2011), combined with:
  • Adenuric (3x/woche)
  • Prednisolon
and developed a serious reaction and side effect(s): Blood Creatine Phosphokinase Increased, Fatigue, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azathioprine treatment in male patients, resulting in Blood Creatine Phosphokinase Increased side effect.
Azathioprine Side Effect Report#9991555
Pancreatitis Acute, Pyrexia, Oropharyngeal Pain
This report suggests a potential Azathioprine Pancreatitis Acute side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: systemic lupus erythematosus,off label use and used Azathioprine (dosage: 125 Mg/day) starting 2006. After starting Azathioprine the patient began experiencing various side effects, including: Pancreatitis Acute, Pyrexia, Oropharyngeal PainAdditional drugs used concurrently: NA.The patient was hospitalized. Although Azathioprine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancreatitis Acute, may still occur.
Azathioprine Side Effect Report#9989193
Hepatitis Cholestatic, Toxicity To Various Agents
This Hepatitis Cholestatic problem was reported by a health professional from Country Not Specified. A 33-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: behcet^s syndrome. On NS this consumer started treatment with Azathioprine (dosage: NA). The following drugs were being taken at the same time: NA. When using Azathioprine, the patient experienced the following unwanted symptoms/side effects: Hepatitis Cholestatic, Toxicity To Various AgentsThe 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 Hepatitis Cholestatic, may become evident only after a product is in use by the general population.
Azathioprine Side Effect Report#9989180
Neutropenia
This Neutropenia side effect was reported by a health professional from Country Not Specified. A 9-year-old male patient (weight:NA) experienced the following symptoms/conditions: erythema multiforme.The patient was prescribed Azathioprine (drug dosage: 30 Mg), which was initiated on NS. Concurrently used drugs: NA..After starting to take Azathioprine the consumer reported adverse symptoms, such as: NeutropeniaThese side effects may potentially be related to Azathioprine.
Azathioprine Side Effect Report#9975796
Dermatitis Allergic
This is a report of a 35-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: autoimmune hepatitis, who was treated with Azathioprine (dosage: NA, start time: NS), combined with:
  • Prednisone (40 Mg)
  • Calcium With Vitamin D
and developed a serious reaction and side effect(s): Dermatitis Allergic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azathioprine treatment in female patients, resulting in Dermatitis Allergic side effect.
Azathioprine Side Effect Report#9969914
Disseminated Tuberculosis, Brain Abscess, Thrombosis, Grand Mal Convulsion
This report suggests a potential Azathioprine Disseminated Tuberculosis side effect(s) that can have serious consequences. A 21-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: crohn^s disease and used Azathioprine (dosage: NA) starting 201008. After starting Azathioprine the patient began experiencing various side effects, including: Disseminated Tuberculosis, Brain Abscess, Thrombosis, Grand Mal ConvulsionAdditional drugs used concurrently:
  • Remicade (V1: Approximately Bimonthly)
The patient was hospitalized. Although Azathioprine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disseminated Tuberculosis, may still occur.
Azathioprine Side Effect Report#9961835
Alveolitis, Respiratory Failure
This Alveolitis problem was reported by a pharmacist from US. A 60-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: respiratory distress. On
Apr 25, 2013 this consumer started treatment with Azathioprine (dosage: NA). The following drugs were being taken at the same time: NA. When using Azathioprine, the patient experienced the following unwanted symptoms/side effects: Alveolitis, Respiratory FailureThe 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 Alveolitis, may become evident only after a product is in use by the general population.
Azathioprine Side Effect Report#9926259
Hepatitis Cholestatic, Nausea, Vomiting, Asthenia
This Hepatitis Cholestatic side effect was reported by a health professional from TR. A 33-year-old male patient (weight:NA) experienced the following symptoms/conditions: behcet^s syndrome,off label use.The patient was prescribed Azathioprine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Azathioprine the consumer reported adverse symptoms, such as: Hepatitis Cholestatic, Nausea, Vomiting, AstheniaThese side effects may potentially be related to Azathioprine. The patient was hospitalized.
Azathioprine Side Effect Report#9925273
Histiocytosis Haematophagic, Cytomegalovirus Infection, Pancytopenia, Neutropenic Sepsis, Cholecystitis, Acute Respiratory Distress Syndrome
This is a report of a 21-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Azathioprine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Histiocytosis Haematophagic, Cytomegalovirus Infection, Pancytopenia, Neutropenic Sepsis, Cholecystitis, Acute Respiratory Distress Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azathioprine treatment in female patients, resulting in Histiocytosis Haematophagic side effect. The patient was hospitalized.
Azathioprine Side Effect Report#9924053
Hypospadias, Exposure Via Father
This report suggests a potential Azathioprine Hypospadias side effect(s) that can have serious consequences. A 0-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: colitis ulcerative,oral contraception and used Azathioprine (dosage: 150 [mg/d (vater) ]) starting
Sep 22, 2007. After starting Azathioprine the patient began experiencing various side effects, including: Hypospadias, Exposure Via FatherAdditional drugs used concurrently:
  • Microgynon (0.03 [mg/d (mother) ] / 0.15 [mg/d (mother) ])
  • Mesalazine (150 [mg/d Father) ])
  • Folio Forte (0.8 [mg/d ])
Although Azathioprine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypospadias, may still occur.
Azathioprine Side Effect Report#9920777
Fatigue, Mental Disability, Myalgia, Feeling Abnormal
This Fatigue problem was reported by a consumer or non-health professional from GB. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On
May 01, 2012 this consumer started treatment with Azathioprine (dosage: NA). The following drugs were being taken at the same time:
  • Prednisolone (Started 60mg/day, Reducing By 5mg/month, Then By 1mg/month To 3mg/day)
  • Adcal D3
  • Omeprazole
  • Simvastatin
  • Aspirin
When using Azathioprine, the patient experienced the following unwanted symptoms/side effects: Fatigue, Mental Disability, Myalgia, Feeling AbnormalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fatigue, may become evident only after a product is in use by the general population.
Azathioprine Side Effect Report#9917494
Acute Febrile Neutrophilic Dermatosis
This Acute Febrile Neutrophilic Dermatosis side effect was reported by a health professional from Country Not Specified. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Azathioprine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Azathioprine the consumer reported adverse symptoms, such as: Acute Febrile Neutrophilic DermatosisThese side effects may potentially be related to Azathioprine. The patient was hospitalized.
Azathioprine Side Effect Report#9916999
Hypersensitivity
This is a report of a 68-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Azathioprine (dosage: NA, start time: NS), combined with:
  • Prednisone
and developed a serious reaction and side effect(s): Hypersensitivity after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azathioprine treatment in male patients, resulting in Hypersensitivity side effect.
Azathioprine Side Effect Report#9912067
Acute Febrile Neutrophilic Dermatosis, Confusional State, Hypersensitivity
This report suggests a potential Azathioprine Acute Febrile Neutrophilic Dermatosis side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: crohn^s disease and used Azathioprine (dosage: NA) starting NS. After starting Azathioprine the patient began experiencing various side effects, including: Acute Febrile Neutrophilic Dermatosis, Confusional State, HypersensitivityAdditional drugs used concurrently: NA.The patient was hospitalized. Although Azathioprine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Febrile Neutrophilic Dermatosis, may still occur.
Azathioprine Side Effect Report#9911264
Leukocytosis, Conjunctivitis, Epidural Lipomatosis
This Leukocytosis problem was reported by a health professional from Country Not Specified. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On NS this consumer started treatment with Azathioprine (dosage: 75 Mg). The following drugs were being taken at the same time:
  • Prednisone (40 Mg)
  • Prednisone (30 Mg)
  • Prednisone (20 Mg)
When using Azathioprine, the patient experienced the following unwanted symptoms/side effects: Leukocytosis, Conjunctivitis, Epidural LipomatosisThe 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 Leukocytosis, may become evident only after a product is in use by the general population.
Azathioprine Side Effect Report#9892721
Cough, Nasal Congestion
This Cough side effect was reported by a health professional from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: crohn^s disease.The patient was prescribed Azathioprine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Prednisone
.After starting to take Azathioprine the consumer reported adverse symptoms, such as: Cough, Nasal CongestionThese side effects may potentially be related to Azathioprine.
Azathioprine Side Effect Report#9892694
Colon Cancer
This is a report of a 51-year-old male patient (weight: NA) from SE, suffering from the following health symptoms/conditions: NA, who was treated with Azathioprine (dosage: NA, start time: NS), combined with:
  • Remicade
and developed a serious reaction and side effect(s): Colon Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azathioprine treatment in male patients, resulting in Colon Cancer side effect.
Azathioprine Side Effect Report#9887717
Myelodysplastic Syndrome
This report suggests a potential Azathioprine (azathioprine) Myelodysplastic Syndrome side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Azathioprine (azathioprine) (dosage: NA) starting NS. After starting Azathioprine (azathioprine) the patient began experiencing various side effects, including: Myelodysplastic SyndromeAdditional drugs used concurrently:
  • Capecitabine (capecitabine) (capecitabine)
Although Azathioprine (azathioprine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myelodysplastic Syndrome, may still occur.
Azathioprine Side Effect Report#9887485
Pyrexia, Chills, Cough, Back Pain, Arthralgia, C-reactive Protein Increased, Diarrhoea, Rash Pustular
This Pyrexia problem was reported by a health professional from BE. A 51-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On NS this consumer started treatment with Azathioprine (dosage: NA). The following drugs were being taken at the same time:
  • Entocort (budesonide)
When using Azathioprine, the patient experienced the following unwanted symptoms/side effects: Pyrexia, Chills, Cough, Back Pain, Arthralgia, C-reactive Protein Increased, Diarrhoea, Rash PustularThe 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 Pyrexia, may become evident only after a product is in use by the general population.
Azathioprine Side Effect Report#9867097
Shock, Erythema, Renal Failure, Heart Rate Increased, Body Temperature Increased, Nasal Discomfort, Mouth Ulceration, Dizziness, Unevaluable Event
This Shock side effect was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: autoimmune disorder,liver disorder.The patient was prescribed Azathioprine (drug dosage: NA), which was initiated on
Dec 17, 2013. Concurrently used drugs: NA..After starting to take Azathioprine the consumer reported adverse symptoms, such as: Shock, Erythema, Renal Failure, Heart Rate Increased, Body Temperature Increased, Nasal Discomfort, Mouth Ulceration, Dizziness, Unevaluable EventThese side effects may potentially be related to Azathioprine. The patient was hospitalized.
Azathioprine Side Effect Report#9863717
Actinic Keratosis, Myelodysplastic Syndrome, Squamous Cell Carcinoma Of Skin
This is a report of a 69-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: renal transplant, who was treated with Azathioprine (dosage: NA, start time: NS), combined with:
  • Prednisone
  • Capecitabine
  • Aspirin
  • Enalapril
  • Simvastatin
  • Tamsulosin
and developed a serious reaction and side effect(s): Actinic Keratosis, Myelodysplastic Syndrome, Squamous Cell Carcinoma Of Skin after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azathioprine treatment in male patients, resulting in Actinic Keratosis side effect.
Azathioprine Side Effect Report#9863364
Pancreatitis Acute, Pulmonary Tuberculosis, Pneumonia Klebsiella, Transplant Dysfunction, Klebsiella Infection
This report suggests a potential Azathioprine Pancreatitis Acute side effect(s) that can have serious consequences. A 36-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: renal transplant and used Azathioprine (dosage: NA) starting NS. After starting Azathioprine the patient began experiencing various side effects, including: Pancreatitis Acute, Pulmonary Tuberculosis, Pneumonia Klebsiella, Transplant Dysfunction, Klebsiella InfectionAdditional drugs used concurrently:
  • Prednisone
  • Cyclosporine
The patient was hospitalized. Although Azathioprine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pancreatitis Acute, may still occur.
Azathioprine Side Effect Report#9853675
Acute Febrile Neutrophilic Dermatosis, Conjunctivitis
This Acute Febrile Neutrophilic Dermatosis problem was reported by a health professional from Country Not Specified. A 38-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: anti-neutrophil cytoplasmic antibody positive vasculitis. On NS this consumer started treatment with Azathioprine (dosage: 200 Mg). The following drugs were being taken at the same time: NA. When using Azathioprine, the patient experienced the following unwanted symptoms/side effects: Acute Febrile Neutrophilic Dermatosis, ConjunctivitisThe 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 Acute Febrile Neutrophilic Dermatosis, may become evident only after a product is in use by the general population.
Azathioprine Side Effect Report#9848575
Rectal Haemorrhage, Irritable Bowel Syndrome, Diarrhoea, Abdominal Pain
This Rectal Haemorrhage side effect was reported by a consumer or non-health professional from US. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Azathioprine (drug dosage: NA), which was initiated on
Dec 26, 2013. Concurrently used drugs: NA..After starting to take Azathioprine the consumer reported adverse symptoms, such as: Rectal Haemorrhage, Irritable Bowel Syndrome, Diarrhoea, Abdominal PainThese side effects may potentially be related to Azathioprine.
Azathioprine Side Effect Report#9845979
Cognitive Disorder, Gait Disturbance, Product Substitution Issue
This is a report of a 58-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Azathioprine (dosage: 1 Tablet Once Daily Taken By Mouth, start time:
Nov 01, 2012), combined with:
  • Imuran (1 Tablet Once Daily Taken By Mouth)
and developed a serious reaction and side effect(s): Cognitive Disorder, Gait Disturbance, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Azathioprine treatment in female patients, resulting in Cognitive Disorder side effect.


1 of 73 


The appearance of Azathioprine 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 Azathioprine Side Effects for Women?

Women Side EffectsReports
Pancytopenia 48
Pyrexia 47
Dyspnoea 33
Nausea 32
Crohn's Disease 30
Fatigue 30
Diarrhoea 29
Abdominal Pain 27
Histiocytosis Haematophagic 27
Vomiting 25

What are common Azathioprine Side Effects for Men?

Men Side EffectsReports
Pyrexia 69
Diarrhoea 46
Pancytopenia 42
Fatigue 40
Nausea 40
Vomiting 35
Arthralgia 34
Crohn's Disease 33
Chills 32
Leukopenia 32

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.

    Azathioprine 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.

    Discuss Azathioprine Side Effects

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    How Effective is Azathioprine for You?

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    Azathioprine Safety Alerts, Active Ingredients, Usage Information

    NDC0054-4084
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAzathioprine
    NameAzathioprine
    Dosage FormTABLET
    RouteORAL
    On market since19960216
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)AZATHIOPRINE
    Strength(s)50
    Unit(s)mg/1
    Pharma ClassNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolit

    Azathioprine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1801

    Azathioprine safety alerts: 2011 2006

    Reported deaths: 280

    Reported hospitalizations: 835

    Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

     

    [UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include:

    • patient characteristics (age, gender, no patient identifiers)
    • risk factors for malignancy
    • exposure to other immune suppressing products or products with risk of malignancy
    • indication for TNF blocker treatment
    • TNF blocker exposure (duration, dose)
    • cancer diagnosis (date of diagnosis, stage)
    • biopsy results
    • outcomes of malignancy (treatments, event outcome)

     

    [Posted 04/14/2011]

    AUDIENCE: Rheumatology, Gastroenterology, Oncology, Dermatology

    ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.  TNF blockers include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

    BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

    Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

    RECOMMENDATIONS:

    • Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
    • Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
    • Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.

    Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [11/03/2011 - Drug Safety Communication - FDA]
    [04/14/2011 - Drug Safety Communication - FDA]

    Previous MedWatch Alert:

    [08/04/2009]

    Latest Azathioprine clinical trials