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Headache (10)
Back Ache (8)
Abdominal Pain (6)
Memory Loss (5)
Eyes (4)
Bone Marrow Suppression Leading To Severe Anemia (3)
Fever (3)
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Azathioprine Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1540 

Myocardial Infarction, Pulmonary Embolism (8424009-6)
on Jun 04, 2012 Female from UNITED STATES , 30 years of age, was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: myocardial infarction, pulmonary embolism. Azathioprine dosage: 100 Mg, Unk.
Associated medications used:
  • Anaesthetics
  • Cyclosporine (Unk Ukn, Unk)
  • Prednisone (Unk Ukn, Unk)


Hydrocephalus (8424008-4)
Patient was taking Azathioprine. Patient felt the following Azathioprine side effects: hydrocephalus on May 31, 2012 from TURKEY Additional patient health information: Male , 43 years of age, was diagnosed with
  • renal transplant
and. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Cyclosporine


Cerebrovascular Accident, Epilepsy (8424002-3)
Adverse event was reported on May 31, 2012 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with
  • renal transplant
and. Location: TURKEY , 55 years of age, After Azathioprine was administered, patient encountered several Azathioprine side effects: cerebrovascular accident, epilepsy.
Multiple concurrent drugs taken:
  • Cyclosporine


Meningeal Disorder, Central Obesity, Headache, Cataract, Sarcoidosis (8424001-1)
on May 30, 2012 Female from UNITED KINGDOM , 42 years of age, was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: meningeal disorder, central obesity, headache, cataract, sarcoidosis. Azathioprine dosage: 50 Mg, Daily.
Associated medications used:
  • Mycophenolate Mofetil
  • Steroids Nos (10 Mg, Unk)
  • Cyclosporine
  • Steroids Nos (40 Mg, Unk)
  • Prednisolone



Pulmonary Fibrosis, Dyspnoea (8421853-6)
on Jun 05, 2012 Female from UNITED STATES , weighting 250.0 lb, was diagnosed with
  • carpal tunnel syndrome
  • arthritis
and was treated with Azathioprine. Patient felt the following Azathioprine side effects: pulmonary fibrosis, dyspnoea. Azathioprine dosage: 50mg 1 A Day. Patient was hospitalized and became disabled.

Systemic Lupus Erythematosus, Skin Lesion, Rebound Effect, Malaise (8421806-8)
Patient was taking Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: systemic lupus erythematosus, skin lesion, rebound effect, malaise on May 30, 2012 from JAPAN Additional patient health information: Female , 40 years of age, was diagnosed with
  • systemic lupus erythematosus
  • arthralgia
and. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Meloxicam
  • Hydroxychloroquine Sulfate
  • Diclofenac Sodium
  • Hydroxychloroquine Sulfate (Resumed)
  • Prednisolone


Vomiting, Nausea, Cytomegalovirus Infection, Large Intestinal Ulcer, Purulence, Large Intestine Perforation, Opportunistic Infection, Peritonitis (8420158-7)
Adverse event was reported on May 25, 2012 by a Female taking Azathioprine (Dosage: 50 Mg/day) was diagnosed with
  • systemic lupus erythematosus
and. Location: AUSTRIA , 58 years of age, Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: vomiting, nausea, cytomegalovirus infection, large intestinal ulcer, purulence, large intestine perforation, opportunistic infection, peritonitis.
Associated medications used:
  • Mycophenolic Acid
  • Methylprednisolone (60 Mg/day)
  • Methylprednisolone (4 Mg/day; Then Increased To 60 Mg/day)
Patient was hospitalized.

Hydrocephalus (8419816-X)
on May 31, 2012 Male from TURKEY , 43 years of age, was diagnosed with
  • renal transplant
and was treated with Azathioprine. Patient felt the following Azathioprine side effects: hydrocephalus. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Cyclosporine


Neuropathy Peripheral (8419814-6)
on May 31, 2012 Male from TURKEY , 69 years of age, was diagnosed with
  • renal transplant
and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: neuropathy peripheral. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Mycophenolate Mofetil
  • Tacrolimus


Erythema Nodosum, Nausea, Abdominal Pain Upper, Vomiting, Pancreatitis Acute (8417521-7)
Patient was taking Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: erythema nodosum, nausea, abdominal pain upper, vomiting, pancreatitis acute on May 24, 2012 from TAIWAN, PROVINCE OF CHINA Additional patient health information: Male , 57 years of age, was diagnosed with
  • dermatitis atopic
and. Azathioprine dosage: 100 Mg/day. Patient was hospitalized.

Joint Swelling (8416477-0)
Adverse event was reported on May 28, 2012 by a Male taking Azathioprine (Dosage: N/A) . Location: CANADA , weighting 145.5 lb, Patient felt the following Azathioprine side effects: joint swelling.
Multiple prescriptions taken:
  • Percocet
  • Remicade (Received 2 Doses; Next Dose In 4 Weeks; Maintenance Dose In Every 8 Weeks.)
  • Imovane


Off Label Use, Lung Adenocarcinoma (8415762-6)
on May 29, 2012 Female from BELGIUM , 60 years of age, was diagnosed with
  • lung transplant
and was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: off label use, lung adenocarcinoma. Azathioprine dosage: Unk.
Multiple concurrent drugs taken:
  • Methylprednisolone (Unk)
  • Tacrolimus (Unk)


Maternal Exposure During Pregnancy, Hypertension, Proteinuria, Premature Delivery (8415742-0)
on Jun 01, 2011 Female from TURKEY , 41 years of age, was diagnosed with
  • renal transplant
  • hypertension
and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: maternal exposure during pregnancy, hypertension, proteinuria, premature delivery. Azathioprine dosage: Unk.
Associated medications used:
  • Methyldopa (Unk)
  • Tacrolimus (Unk)
  • Tacrolimus (Unk)
Patient was hospitalized.

Bone Disorder, Nerve Compression, Viith Nerve Paralysis, Herpes Zoster (8415043-0)
Patient was taking Azathioprine. Patient felt the following Azathioprine side effects: bone disorder, nerve compression, viith nerve paralysis, herpes zoster on May 25, 2012 from UNITED STATES Additional patient health information: Male , weighting 150.0 lb, was diagnosed with
  • colitis ulcerative
and. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Remicade (Double Dose/solution)


Colectomy, Ileostomy (8407543-4)
Adverse event was reported on May 25, 2012 by a Female taking Azathioprine (Dosage: N/A) was diagnosed with
  • colitis ulcerative
and. Location: DENMARK , 28 years of age, weighting 156.5 lb, After Azathioprine was administered, patient encountered several Azathioprine side effects: colectomy, ileostomy.
Multiple concurrent drugs taken:
  • Humira
  • Remicade
  • Mesalamine
Patient was hospitalized.

Off Label Use (8406664-X)
on May 29, 2012 Male from BELGIUM , 65 years of age, was diagnosed with
  • lung transplant
and was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: off label use. Azathioprine dosage: Unk.
Associated medications used:
  • Tacrolimus (Unk)
  • Methylprednisolone (Unk)


Syncope, Ataxia, Paraesthesia, Visual Acuity Reduced, Asthenia (8406584-0)
on May 24, 2012 Female from GERMANY , weighting 73.41 lb, was treated with Azathioprine. Patient felt the following Azathioprine side effects: syncope, ataxia, paraesthesia, visual acuity reduced, asthenia. Azathioprine dosage: N/A.
Multiple prescriptions taken:
  • Mesalamine
  • Remicade
Patient was hospitalized.

Lung Neoplasm Malignant, Atrial Fibrillation, Nasopharyngitis, Respiratory Tract Congestion, Lung Disorder, Crohn's Disease, Diarrhoea, Sinusitis, Rhinorrhoea (8397045-6)
Patient was taking Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: lung neoplasm malignant, atrial fibrillation, nasopharyngitis, respiratory tract congestion, lung disorder, crohn's disease, diarrhoea, sinusitis, rhinorrhoea on May 22, 2012 from UNITED STATES Additional patient health information: Male , weighting 255.2 lb, was diagnosed with
  • crohn's disease
and. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Lialda
  • Prevacid
  • Humira
  • Lialda


Anaemia, Pallor, Asthenia, Platelet Count Decreased, Red Blood Cell Count Decreased, Dyspnoea, Visual Acuity Reduced, White Blood Cell Count Decreased (8396751-7)
Adverse event was reported on May 23, 2012 by a Male taking Azathioprine (Dosage: N/A) was diagnosed with
  • autoimmune hepatitis
and. Location: UNITED STATES , 17 years of age, weighting 135.0 lb, Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: anaemia, pallor, asthenia, platelet count decreased, red blood cell count decreased, dyspnoea, visual acuity reduced, white blood cell count decreased. Patient was hospitalized.

Platelet Count Decreased, Visual Acuity Reduced, Pallor, Red Blood Cell Count Decreased, Dyspnoea, Anaemia, Asthenia, White Blood Cell Count Decreased (8396750-5)
on May 23, 2012 Male from UNITED STATES , 17 years of age, weighting 135.0 lb, was diagnosed with
  • autoimmune hepatitis
and was treated with Azathioprine. Patient felt the following Azathioprine side effects: platelet count decreased, visual acuity reduced, pallor, red blood cell count decreased, dyspnoea, anaemia, asthenia, white blood cell count decreased. Azathioprine dosage: N/A. Patient was hospitalized.

Pruritus (8395636-X)
on Dec 27, 2011 Female from UNITED STATES , 68 years of age, was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: pruritus. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Remicade
  • Hydrochlorothiazide
  • Calcium
  • Spiriva
  • Folic Acid
  • Levothyroxine Sodium
  • Pravastatin
  • Leflunomide


Encephalitis, Hemiplegia (8393928-1)
Patient was taking Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: encephalitis, hemiplegia on May 08, 2012 from GERMANY Additional patient health information: Female , 26 years of age, . Azathioprine dosage: N/A.
Associated medications used:
  • Prednisone Tab
  • Escitalopram
  • Nuvaring (Vag ; Vag)
  • Nuvaring (Vag ; Vag)
Patient was hospitalized.

Cytomegalovirus Colitis (8388175-3)
Adverse event was reported on May 15, 2012 by a Female taking Azathioprine Sodium (Dosage: N/A) . Location: AUSTRIA , weighting 136.7 lb, Patient felt the following Azathioprine side effects: cytomegalovirus colitis.
Multiple prescriptions taken:
  • Remicade
  • Mesagran
Patient was hospitalized.

Intestinal Obstruction (8385141-9)
on May 16, 2012 Female from UNITED STATES , weighting 130.1 lb, was treated with Azathioprine. After Azathioprine was administered, patient encountered several Azathioprine side effects: intestinal obstruction. Azathioprine dosage: N/A.
Multiple concurrent drugs taken:
  • Humira
  • Remeron
Patient was hospitalized.

Anal Fistula, Subcutaneous Abscess (8376308-4)
on May 10, 2012 Female from FRANCE , weighting 103.6 lb, was treated with Azathioprine. Directly after, patient experienced the unwanted or unexpected Azathioprine side effects: anal fistula, subcutaneous abscess. Azathioprine dosage: N/A.
Associated medications used:
  • Remicade
Patient was hospitalized.

Showing 1-25 of 1540 

Azathioprine Health Episodes

How Can Azathioprine Affect You?

I am taking Azathioprine for ulcerative colitis. I started this med more than ...Keep Reading

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative AZATHIOPRINE Names:AZATHIOPR

Active Ingredient: AZATHIOPR

Azathioprine Dosage, Warnings, Usage.

Side Effects reported to FDA: 1540. View Azathioprine Adverse Reports

Azathioprine safety alerts: 2011 2006

Reported deaths: 247

Reported hospitalizations: 698

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]

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