PatientsVille.com Logo

PatientsVille
Azathioprine Side Effects

Report Azathioprine Side Effects

If you experienced any harmful or unwanted effects of Azathioprine, please share your experience. This could help to raise awareness about Azathioprine side effects, identify uknown risks and inform health professionals and patients taking Azathioprine.

Examples: headache, dizziness


The most commonly reported Azathioprine side effects are:
Headache (11 reports)
Back Ache (9 reports)
Abdominal Pain (6 reports)
Memory Loss (5 reports)
Eyes (4 reports)
Bone Marrow Suppression Leading To Severe Anemia (3 reports)
Fever (3 reports)
Stomach Pains (3 reports)
Bone Marrow Suppression Leading To Severe Anemia, (2 reports)
Lethargy (2 reports)
Sore Throat (2 reports)
Weakerness (2 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Azathioprine side effects or compare Azathioprine side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.
Anastomotic Stenosis, Posterior Reversible Encephalopathy Syndrome, Cytomegalovirus Infection, Hypertension
on Jan 27, 2014 Female from US , 17 years of age, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: anastomotic stenosis, posterior reversible encephalopathy syndrome, cytomegalovirus infection, hypertension. Azathioprine dosage: N/A.
Associated medications used:
  • Prednisone
  • Enalapril
  • Amlodipine
  • Tacrolimus
  • Metoprolol
Patient was hospitalized.

Histiocytosis Haematophagic, Cytomegalovirus Infection, Cholecystitis, Enterococcal Infection, Acute Respiratory Distress Syndrome, Neutropenic Sepsis
Patient was taking Azathioprine. Patient felt the following Azathioprine side effects: histiocytosis haematophagic, cytomegalovirus infection, cholecystitis, enterococcal infection, acute respiratory distress syndrome, neutropenic sepsis on Jan 20, 2014 from HU Additional patient health information: Female , 21 years of age, was diagnosed with and. Azathioprine dosage: N/A. Patient was hospitalized.

Acute Febrile Neutrophilic Dermatosis
Adverse event was reported on Jan 20, 2014 by a Male taking Azathioprine (Dosage: 200mg/day) was diagnosed with and. Location: PT , 38 years of age, After Azathioprine was administered, patient encountered several Azathioprine side effects: acute febrile neutrophilic dermatosis.

Aplastic Anaemia, Candida Infection, Bacteroides Infection, Thrombocytopenia, Pulmonary Alveolar Haemorrhage, Zygomycosis, Pancytopenia
on Jan 15, 2014 Female from US , 53 years of age, was diagnosed with and was treated with Azathioprine (azathioprine). Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: aplastic anaemia, candida infection, bacteroides infection, thrombocytopenia, pulmonary alveolar haemorrhage, zygomycosis, pancytopenia. Azathioprine (azathioprine) dosage: 50.00-mg-1.0days. Patient was hospitalized.


Renal Failure Acute, Hypotension, Urticaria
on Jan 15, 2014 Female from US , 71 years of age, was treated with Azathioprine. Patient felt the following Azathioprine side effects: renal failure acute, hypotension, urticaria. Azathioprine dosage: 50 Mg. Patient was hospitalized.

Macrocytosis, Myelodysplastic Syndrome, Pancytopenia, Vitamin B12 Deficiency
Patient was taking Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: macrocytosis, myelodysplastic syndrome, pancytopenia, vitamin b12 deficiency on Jan 15, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Female , 47 years of age, was diagnosed with and. Azathioprine dosage: N/A.

Bone Marrow Failure, Aplastic Anaemia, Respiratory Failure, Pulmonary Alveolar Haemorrhage, Febrile Neutropenia, Staphylococcal Sepsis, Candida Infection, Bacteroides Infection, Zygomycosis
Adverse event was reported on Jan 15, 2014 by a Female taking Azathioprine (Dosage: 50 Mg) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 53 years of age, Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: bone marrow failure, aplastic anaemia, respiratory failure, pulmonary alveolar haemorrhage, febrile neutropenia, staphylococcal sepsis, candida infection, bacteroides infection, zygomycosis.
Associated medications used:
  • Methylprednisolone (4 Mg)
  • Methylprednisolone (48 Mg)
  • Methylprednisolone (1 G)
  • Digoxin
  • Furosemide
  • Clopidogrel
  • Potassium Chloride
  • Ranitidine
Patient was hospitalized.

Liver Disorder, Retroperitoneal Abscess, Thrombocytopenia, Cholestasis, Hepatosplenomegaly, Ascites, Portal Hypertension
on Jan 03, 2014 Male from ES , 47 years of age, was treated with Azathioprine (azathioprine). Patient felt the following Azathioprine side effects: liver disorder, retroperitoneal abscess, thrombocytopenia, cholestasis, hepatosplenomegaly, ascites, portal hypertension. Azathioprine (azathioprine) dosage: N/A. Patient was hospitalized.

Dehydration, Diarrhoea, Renal Impairment
on Jan 02, 2014 Male from GB , 24 years of age, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: dehydration, diarrhoea, renal impairment. Azathioprine dosage: N/A. Patient was hospitalized.

Dental Caries
Patient was taking Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: dental caries on Dec 30, 2013 from GB Additional patient health information: Female , 35 years of age, weighting 141.1 lb, was diagnosed with and. Azathioprine dosage: N/A.

Intestinal Stenosis
Adverse event was reported on Jan 16, 2014 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with and. Location: KR , 15 years of age, weighting 131.4 lb, Patient felt the following Azathioprine side effects: intestinal stenosis.
Multiple prescriptions taken:
  • Centrum (minerals Nos, Vitamins Nos)
  • Peniramin
  • Peniramin
  • Peniramin
  • Curan
  • Ketamine
  • Cololyt
  • Midazolam
Patient was hospitalized.

Pancreatitis
on Dec 20, 2013 Male from US , 43 years of age, weighting 160.3 lb, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: pancreatitis. Azathioprine dosage: N/A. Patient was hospitalized.

Aplastic Anaemia, Staphylococcal Infection, Candida Infection, Bacteroides Infection, Zygomycosis, Respiratory Failure, Pulmonary Alveolar Haemorrhage, Pancytopenia, Diffuse Alopecia
on Dec 20, 2013 Female from US , 53 years of age, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: aplastic anaemia, staphylococcal infection, candida infection, bacteroides infection, zygomycosis, respiratory failure, pulmonary alveolar haemorrhage, pancytopenia, diffuse alopecia. Azathioprine dosage: 50mg Daily.
Associated medications used:
  • Potassium Chloride
  • Ranitidine
  • Digoxin
  • Furosemide
  • Methylprednisolone (4mg Daily)
  • Gabapentin
  • Risedronic Acid
  • Benazepril
Patient was hospitalized.

Multi-organ Failure, Cerebral Haemorrhage, Bone Marrow Failure, Sepsis
Patient was taking Azathioprine. Patient felt the following Azathioprine side effects: multi-organ failure, cerebral haemorrhage, bone marrow failure, sepsis on Dec 19, 2013 from GB Additional patient health information: Male , 22 years of age, weighting 103.6 lb, was diagnosed with and. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Pentasa (4 Gram Daily;)
  • Pentasa (1 Gram Daily; 1 Gr At Night)
  • Prednisolone
  • Omeprazole
  • Adcal-d3 (2 Dosage Forms Daily;)


Aplastic Anaemia, Candida Infection, Bacteroides Infection, Respiratory Failure, Staphylococcal Infection, Plasmacytosis, Zygomycosis, Pyrexia
Adverse event was reported on Dec 19, 2013 by a Female taking Azathioprine (Dosage: 50 Mg, Unk) was diagnosed with and. Location: US , 53 years of age, After Azathioprine was administered, patient encountered several Azathioprine side effects: aplastic anaemia, candida infection, bacteroides infection, respiratory failure, staphylococcal infection, plasmacytosis, zygomycosis, pyrexia.
Multiple concurrent drugs taken:
  • Methylprednisolone (4 Mg, Unk)
  • Methylprednisolone (16 Mg, Q8h)
  • Methylprednisolone (1 G, Q8h)
  • Methylprednisolone (16 Mg, Q8h)
  • Potassium Chloride
  • Ranitidine
  • Furosemide
  • Gabapentin
Patient was hospitalized.

Histiocytosis Haematophagic, Epstein-barr Virus Infection, H1n1 Influenza
on Dec 18, 2013 Female from COUNTRY NOT SPECIFIED , 14 years of age, was diagnosed with and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: histiocytosis haematophagic, epstein-barr virus infection, h1n1 influenza. Azathioprine dosage: N/A. Patient was hospitalized.

Crohn^s Disease
on Dec 17, 2013 Male from GB , 42 years of age, was diagnosed with and was treated with Azathioprine. Patient felt the following Azathioprine side effects: crohn^s disease. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Clozaril


Bone Marrow Failure, Neutropenic Sepsis
Patient was taking Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: bone marrow failure, neutropenic sepsis on Dec 17, 2013 from GB Additional patient health information: Male , 49 years of age, weighting 191.8 lb, was diagnosed with and. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Pentasa
Patient was hospitalized.

Cerebral Haemorrhage, Multi-organ Failure, Bone Marrow Failure, Sepsis
Adverse event was reported on Dec 17, 2013 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with and. Location: GB , 22 years of age, weighting 103.6 lb, Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: cerebral haemorrhage, multi-organ failure, bone marrow failure, sepsis.
Associated medications used:
  • Adcal D3
  • Omeprazole
  • Pentasa
  • Pentasa
  • Prednisolone


Epstein-barr Virus Infection, Histiocytosis Haematophagic
on Dec 16, 2013 Female from GB , 14 years of age, was diagnosed with and was treated with Azathioprine. Patient felt the following Azathioprine side effects: epstein-barr virus infection, histiocytosis haematophagic. Azathioprine dosage: 1.5 Mg/kg/day. Patient was hospitalized.

Pemphigus, Kaposi^s Varicelliform Eruption, Thrombocytopenia, Dermatitis Bullous, Skin Lesion, Blister, Pain, Odynophagia
on Dec 12, 2013 Male from BR , 33 years of age, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: pemphigus, kaposi^s varicelliform eruption, thrombocytopenia, dermatitis bullous, skin lesion, blister, pain, odynophagia. Azathioprine dosage: 150 Mg, Daily.
Multiple concurrent drugs taken:
  • Methylprednisolone (1 G, Daily)
  • Mycophenolate Mofetil (3 G, Daily)
  • Dexamethasone (100 Mg, Daily)
  • Prednisolone (1 Mg Per Kg Daily)
  • Prednisolone (1.5 Mg Per Kg Daily)
  • Prednisolone (2 Mg Per Kg Daily)
  • Prednisolone (5 Mg, Daily)
  • Prednisolone (20 Mg, Daily)
Patient was hospitalized.

Encephalopathy, Coma, Hypersensitivity
Patient was taking Azathioprine (azathioprine). Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: encephalopathy, coma, hypersensitivity on Nov 29, 2013 from GB Additional patient health information: Male , 73 years of age, was diagnosed with and. Azathioprine (azathioprine) dosage: N/A.
Associated medications used:
  • Prednisolone
  • Lisinopril
  • Cotrimoxazole
  • Gliclazide
  • Folic Acid
  • Hydroxocobalamin
  • Ranitidine
Patient was hospitalized.

Syndactyly, Exposure During Pregnancy
Adverse event was reported on Nov 26, 2013 by a Male taking Azathioprine (Dosage: 100 [mg/d ]) . Location: DE , weighting 7.17 lb, Patient felt the following Azathioprine side effects: syndactyly, exposure during pregnancy.
Multiple prescriptions taken:
  • Adalimumab (40 [mg/wk ])
  • Folio Forte
  • Udc (250 [mg/d ])
  • Vitamin B12
  • Omega-3
  • Influsplit Ssw


Anaemia, Leukopenia, Dyspnoea
on Nov 26, 2013 Male from GB , 43 years of age, was diagnosed with and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: anaemia, leukopenia, dyspnoea. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Allopurinol
  • Citalopram


Haematochezia, Alopecia
on Nov 20, 2013 Female from AT , 40 years of age, was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: haematochezia, alopecia. Azathioprine dosage: 37.5 Mg, Unk.
Associated medications used:
  • Prednisolone (5 Mg, Unk)
  • 6-mercaptopurine


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