PatientsVille.com Logo

PatientsVille

Azathioprine Side Effects

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.

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.

Azathioprine Side Effects Reported to FDA

The following 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.


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.
Blood Creatine Phosphokinase Increased, Fatigue, Somnolence
on Mar 10, 2014 Male from DE , 60 years of age, weighting 248.7 lb, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: blood creatine phosphokinase increased, fatigue, somnolence. Azathioprine dosage: Daily Dose: 50 Mg Millgram(s) Every Days.
Associated medications used:
  • Adenuric (3x/woche)
  • Prednisolon


Pancreatitis Acute, Pyrexia, Oropharyngeal Pain
Patient was taking Azathioprine. Patient felt the following Azathioprine side effects: pancreatitis acute, pyrexia, oropharyngeal pain on Mar 10, 2014 from ES Additional patient health information: Female , 33 years of age, was diagnosed with and. Azathioprine dosage: 125 Mg/day. Patient was hospitalized.

Hepatitis Cholestatic, Toxicity To Various Agents
Adverse event was reported on Mar 10, 2014 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 33 years of age, After Azathioprine was administered, patient encountered several Azathioprine side effects: hepatitis cholestatic, toxicity to various agents. Patient was hospitalized.

Neutropenia
on Mar 10, 2014 Male from COUNTRY NOT SPECIFIED , child 9 years of age, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: neutropenia. Azathioprine dosage: 30 Mg.


Dermatitis Allergic
on Mar 06, 2014 Female from COUNTRY NOT SPECIFIED , 35 years of age, was diagnosed with and was treated with Azathioprine. Patient felt the following Azathioprine side effects: dermatitis allergic. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Prednisone (40 Mg)
  • Calcium With Vitamin D


Disseminated Tuberculosis, Brain Abscess, Thrombosis, Grand Mal Convulsion
Patient was taking Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: disseminated tuberculosis, brain abscess, thrombosis, grand mal convulsion on Mar 06, 2014 from US Additional patient health information: Male , 21 years of age, weighting 116.8 lb, was diagnosed with and. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Remicade (V1: Approximately Bimonthly)
Patient was hospitalized.

Alveolitis, Respiratory Failure
Adverse event was reported on Mar 04, 2014 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with and. Location: US , 60 years of age, weighting 202.6 lb, Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: alveolitis, respiratory failure. Patient was hospitalized.

Hepatitis Cholestatic, Nausea, Vomiting, Asthenia
on Feb 26, 2014 Male from TR , 33 years of age, was diagnosed with and was treated with Azathioprine. Patient felt the following Azathioprine side effects: hepatitis cholestatic, nausea, vomiting, asthenia. Azathioprine dosage: N/A. Patient was hospitalized.

Histiocytosis Haematophagic, Cytomegalovirus Infection, Pancytopenia, Neutropenic Sepsis, Cholecystitis, Acute Respiratory Distress Syndrome
on Feb 26, 2014 Female from COUNTRY NOT SPECIFIED , 21 years of age, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: histiocytosis haematophagic, cytomegalovirus infection, pancytopenia, neutropenic sepsis, cholecystitis, acute respiratory distress syndrome. Azathioprine dosage: N/A. Patient was hospitalized.

Hypospadias, Exposure Via Father
Patient was taking Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: hypospadias, exposure via father on Feb 25, 2014 from DE Additional patient health information: Male , child 0 years of age, weighting 8.38 lb, was diagnosed with and. Azathioprine dosage: 150 [mg/d (vater) ].
Associated medications used:
  • Microgynon (0.03 [mg/d (mother) ] / 0.15 [mg/d (mother) ])
  • Mesalazine (150 [mg/d Father) ])
  • Folio Forte (0.8 [mg/d ])


Fatigue, Mental Disability, Myalgia, Feeling Abnormal
Adverse event was reported on Feb 24, 2014 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with and. Location: GB , 63 years of age, weighting 209.4 lb, Patient felt the following Azathioprine side effects: fatigue, mental disability, myalgia, feeling abnormal.
Multiple prescriptions taken:
  • Prednisolone (Started 60mg/day, Reducing By 5mg/month, Then By 1mg/month To 3mg/day)
  • Adcal D3
  • Omeprazole
  • Simvastatin
  • Aspirin


Acute Febrile Neutrophilic Dermatosis
on Feb 21, 2014 Male from COUNTRY NOT SPECIFIED , 75 years of age, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: acute febrile neutrophilic dermatosis. Azathioprine dosage: N/A. Patient was hospitalized.

Hypersensitivity
on Feb 21, 2014 Male from COUNTRY NOT SPECIFIED , 68 years of age, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: hypersensitivity. Azathioprine dosage: N/A.
Associated medications used:
  • Prednisone


Acute Febrile Neutrophilic Dermatosis, Confusional State, Hypersensitivity
Patient was taking Azathioprine. Patient felt the following Azathioprine side effects: acute febrile neutrophilic dermatosis, confusional state, hypersensitivity on Feb 19, 2014 from US Additional patient health information: Male , 75 years of age, was diagnosed with and. Azathioprine dosage: N/A. Patient was hospitalized.

Leukocytosis, Conjunctivitis, Epidural Lipomatosis
Adverse event was reported on Feb 19, 2014 by a Male taking Azathioprine (Dosage: 75 Mg) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 68 years of age, After Azathioprine was administered, patient encountered several Azathioprine side effects: leukocytosis, conjunctivitis, epidural lipomatosis.
Multiple concurrent drugs taken:
  • Prednisone (40 Mg)
  • Prednisone (30 Mg)
  • Prednisone (20 Mg)
Patient was hospitalized.

Cough, Nasal Congestion
on Feb 12, 2014 Male from US , 68 years of age, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: cough, nasal congestion. Azathioprine dosage: N/A.
Associated medications used:
  • Prednisone


Colon Cancer
on Feb 12, 2014 Male from SE , 51 years of age, was treated with Azathioprine. Patient felt the following Azathioprine side effects: colon cancer. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Remicade


Myelodysplastic Syndrome
Patient was taking Azathioprine (azathioprine). After Azathioprine was administered, patient encountered several Azathioprine side effects: myelodysplastic syndrome on Feb 06, 2014 from US Additional patient health information: Male , 69 years of age, . Azathioprine (azathioprine) dosage: N/A.
Multiple concurrent drugs taken:
  • Capecitabine (capecitabine) (capecitabine)


Pyrexia, Chills, Cough, Back Pain, Arthralgia, C-reactive Protein Increased, Diarrhoea, Rash Pustular
Adverse event was reported on Feb 06, 2014 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with and. Location: BE , 51 years of age, Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: pyrexia, chills, cough, back pain, arthralgia, c-reactive protein increased, diarrhoea, rash pustular.
Associated medications used:
  • Entocort (budesonide)
Patient was hospitalized.

Shock, Erythema, Renal Failure, Heart Rate Increased, Body Temperature Increased, Nasal Discomfort, Mouth Ulceration, Dizziness, Unevaluable Event
on Feb 03, 2014 Female from US , 71 years of age, weighting 215.0 lb, was diagnosed with and was treated with Azathioprine. Patient felt the following Azathioprine side effects: shock, erythema, renal failure, heart rate increased, body temperature increased, nasal discomfort, mouth ulceration, dizziness, unevaluable event. Azathioprine dosage: N/A. Patient was hospitalized.

Actinic Keratosis, Myelodysplastic Syndrome, Squamous Cell Carcinoma Of Skin
on Feb 03, 2014 Male from COUNTRY NOT SPECIFIED , 69 years of age, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: actinic keratosis, myelodysplastic syndrome, squamous cell carcinoma of skin. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Prednisone
  • Capecitabine
  • Aspirin
  • Enalapril
  • Simvastatin
  • Tamsulosin


Pancreatitis Acute, Pulmonary Tuberculosis, Pneumonia Klebsiella, Transplant Dysfunction, Klebsiella Infection
Patient was taking Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: pancreatitis acute, pulmonary tuberculosis, pneumonia klebsiella, transplant dysfunction, klebsiella infection on Feb 03, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Male , 36 years of age, was diagnosed with and. Azathioprine dosage: N/A.
Associated medications used:
  • Prednisone
  • Cyclosporine
Patient was hospitalized.

Acute Febrile Neutrophilic Dermatosis, Conjunctivitis
Adverse event was reported on Jan 29, 2014 by a Male taking Azathioprine (Dosage: 200 Mg) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 38 years of age, Patient felt the following Azathioprine side effects: acute febrile neutrophilic dermatosis, conjunctivitis. Patient was hospitalized.

Rectal Haemorrhage, Irritable Bowel Syndrome, Diarrhoea, Abdominal Pain
on Jan 24, 2014 Female from US , 54 years of age, weighting 106.0 lb, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: rectal haemorrhage, irritable bowel syndrome, diarrhoea, abdominal pain. Azathioprine dosage: N/A.

Cognitive Disorder, Gait Disturbance, Product Substitution Issue
on Jan 23, 2014 Female from US , 58 years of age, weighting 225.0 lb, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: cognitive disorder, gait disturbance, product substitution issue. Azathioprine dosage: 1 Tablet Once Daily Taken By Mouth.
Associated medications used:
  • Imuran (1 Tablet Once Daily Taken By Mouth)


1 of 73 

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Azathioprine Side Effects

    Did You Have a Azathioprine Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Azathioprine for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative AZATHIOPRINE Names:AZATHIOPR

    Active Ingredient: AZATHIOPR

    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