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Neoral (Cyclosporine) - Serious Reactions - Suspected Cause - Side Effect Reports

 
 



Index of reports > Serious Reactions (541)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Neoral (Cyclosporine) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 541   Next >>

Possible Neoral side effects in 60 year old male

Reported by a pharmacist from Japan on 2012-08-24

Patient: 60 year old male

Reactions: Oral Administration Complication, Cerebrovascular Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in male

Reported by a physician from France on 2012-08-17

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Urinary Tract Infection Pseudomonal, Prostate Cancer, Oedema Peripheral, General Physical Health Deterioration, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Dosage: 2 g, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-02-13

Neoral
    Dosage: 160 mg, qd
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-02-13

NO Treatment Received
    Dosage: unk
    Indication: Renal Transplant

Prednisolone
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Renal Transplant

Other drugs received by patient: Aranesp; Acetaminophen; Eupressyl; Bactrim; Kayexalate; Omeprazole; Bisoprolol Fumarate; Valacyclovir Hydrochloride; Alprazolam; Cordarone



Possible Neoral side effects in female

Reported by a physician from Korea, Republic of on 2012-08-17

Patient: female, weighing 48.2 kg (106.0 pounds)

Reactions: Convulsion

Drug(s) suspected as cause:
Myfortic
    Dosage: 540 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-10

Neoral
    Dosage: 162.5 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2012-07-07

NO Treatment Received
    Dosage: no treatment received
    Indication: Renal Transplant

Other drugs received by patient: Synthroid; Norvasc; Unasyn; Methylprednisolone; Humulin R; Mucopect; Sucralfate; Ranitidine Hydrochloride



Possible Neoral side effects in

Reported by a pharmacist from Japan on 2012-08-17

Patient:

Reactions: Oral Administration Complication, Cerebrovascular Disorder

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-16

Patient: female

Reactions: Breast Disorder, Reproductive Tract Disorder

Drug(s) suspected as cause:
Certican
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Mycophenolic Acid
    Indication: Renal Transplant

Neoral
    Indication: Renal Transplant

Simulect
    Indication: Renal Transplant



Possible Neoral side effects in female

Reported by a pharmacist from Japan on 2012-08-16

Patient: female

Reactions: Oral Administration Complication, Scleroderma, Concomitant Disease Progression

Drug(s) suspected as cause:
Neoral

Other drugs received by patient: Corticosteroid NOS



Possible Neoral side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male

Reactions: Cardiovascular Insufficiency, Tachycardia, Pyrexia, Left Ventricular Dysfunction, Coronary Artery Thrombosis, Ischaemic Hepatitis, Acute Myocardial Infarction, Anuria, Chest Discomfort, Dyspnoea, Coronary Artery Stenosis, Left Ventricular END-Diastolic Pressure Increased, Hypotension, Blood Creatine Increased, Hepatic Enzyme Increased, Ejection Fraction Decreased, Oliguria, Ventricular Tachycardia, Left Atrial Dilatation, Vasculitis, Ventricular Fibrillation, Electrocardiogram ST Segment Elevation, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Neoral
    Dosage: 75 mg, bid

Neoral
    Dosage: 25 mg, unk
    Indication: Heart Transplant

Other drugs received by patient: Heparin; Prednisone TAB; Lidocaine; Aspirin; Magnesium Oxide; Cellcept; Benazepril Hydrochloride; Angiotensin Converting Enzyme Blockers; Levophed; Steroids NOS; Dopamine HCL; Beta Blocking Agents; Plavix; Lipitor



Possible Neoral side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16

Patient: 48 year old male

Reactions: Dysphagia, Renal Failure, Overdose, Hallucination, Visual

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neoral

Other drugs received by patient: Prednisolone; Cellcept



Possible Neoral side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-13

Patient: 59 year old male

Reactions: Respiratory Disorder, Hallucination, Auditory, Motor Dysfunction, Acute Myeloid Leukaemia, Encephalopathy, Pyrexia, Parkinsonism, Cerebral Toxoplasmosis, Pneumonia Cytomegaloviral, Agnosia, Micturition Disorder, Graft Versus Host Disease in Skin, Cytomegalovirus Infection, Memory Impairment, Altered State of Consciousness, Frustration

Adverse event resulted in: death

Drug(s) suspected as cause:
Neoral

Other drugs received by patient: Methotrexate; Ganciclovir; Fludarabine Phosphate; Melphalan Hydrochloride



Possible Neoral side effects in 22 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 22 year old female

Reactions: Blood Thromboplastin Decreased, Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Neoral
    Indication: Thrombotic Thrombocytopenic Purpura

Neoral
    Dosage: unk



Possible Neoral side effects in

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-10

Patient:

Reactions: Mental Disorder

Drug(s) suspected as cause:
Certican

Mycophenolic Acid
    Indication: Renal Transplant

Neoral
    Indication: Renal Transplant

Simulect



Possible Neoral side effects in female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-10

Patient: female

Reactions: Breast Disorder, Reproductive Tract Disorder

Drug(s) suspected as cause:
Certican
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Mycophenolic Acid
    Indication: Renal Transplant

Neoral
    Indication: Renal Transplant

Simulect
    Indication: Renal Transplant



Possible Neoral side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient:

Reactions: Death, Premature Baby, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in 22 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient: 22 year old female

Reactions: Induced Labour, Maternal Exposure During Pregnancy, General Physical Health Deterioration, Premature Labour, PRE-Eclampsia

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in

Reported by a physician from Japan on 2012-08-09

Patient:

Reactions: Fibrin D Dimer Increased, Oedema Peripheral, Venous Thrombosis, Erythema

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in male

Reported by a consumer/non-health professional from Italy on 2012-08-08

Patient: male

Reactions: Nephrolithiasis, Renal Impairment

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in 3 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-08

Patient: 3 year old female

Reactions: Cytomegalovirus Hepatitis, Hepatic Function Abnormal, Bronchiectasis, Interstitial Lung Disease, Anaemia Haemolytic Autoimmune, Combined Immunodeficiency

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Neoral

Other drugs received by patient: Dexamethasone; Prednisolone; Ganciclovir



Possible Neoral side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-06

Patient: male, weighing 52.0 kg (114.4 pounds)

Reactions: Back Pain, Drug Resistance, Blood Triglycerides Increased, General Physical Health Deterioration, Neoplasm Progression, C-Reactive Protein Decreased, Kidney Transplant Rejection, Renal Failure Chronic, Post Transplant Lymphoproliferative Disorder, Renal Impairment

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Certican
    Dosage: 2.75 mg, unk
    Administration route: Oral
    Start date: 2007-07-28
    End date: 2007-10-07

Certican
    Dosage: 2.75 mg, unk
    Administration route: Oral
    Start date: 2008-09-07
    End date: 2008-09-27

Certican
    Dosage: 4 mg, unk
    Administration route: Oral
    Start date: 2009-07-19

Certican
    Dosage: 3 mg, unk
    Administration route: Oral
    Start date: 2007-07-24
    End date: 2007-07-27

Certican
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Start date: 2008-08-25
    End date: 2008-09-06

Certican
    Dosage: 3 mg, unk
    Administration route: Oral
    Start date: 2009-06-06
    End date: 2009-07-18

Certican
    Dosage: 4.25 mg, daily
    Administration route: Oral
    Start date: 2009-08-22
    End date: 2009-09-03

Certican
    Dosage: 2 mg, unk
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2007-07-13
    End date: 2007-07-23

Certican
    Dosage: 1.75 mg, unk
    Start date: 2008-08-01
    End date: 2008-08-24

Certican
    Dosage: 4.75 mg, unk
    Administration route: Oral
    Start date: 2009-11-13
    End date: 2010-03-02

Certican
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Start date: 2007-10-08

Certican
    Dosage: 3.25 mg, unk
    Administration route: Oral
    Start date: 2008-09-28
    End date: 2009-06-05

Certican
    Dosage: 4.5 mg, daily
    Administration route: Oral
    Start date: 2009-09-04
    End date: 2009-11-12

Certican
    Dosage: 1.25 mg, unk
    Administration route: Oral
    Start date: 2008-07-30
    End date: 2008-07-30

Neoral
    Dosage: unk ukn, unk
    Indication: Renal Transplant
    Start date: 2001-01-01
    End date: 2006-01-01

Neoral
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 1995-01-01
    End date: 2001-01-01

Prednisolone
    Dosage: 5 mg, unk
    Administration route: Oral
    Start date: 2008-07-30

Prograf
    Dosage: unk ukn, unk
    Administration route: Oral
    Start date: 2001-01-01
    End date: 2006-12-01

Prograf
    Dosage: 3 mg, unk
    Administration route: Oral
    Start date: 2008-08-01
    End date: 2008-08-22

Prograf
    Dosage: 4 mg, unk
    Administration route: Oral
    Start date: 2002-02-19
    End date: 2007-07-12

Prograf
    Dosage: 2.25 mg, unk
    Administration route: Oral
    Start date: 2008-08-23
    End date: 2008-08-25

Prograf
    Dosage: 0.5 mg, unk
    Administration route: Oral
    Start date: 2007-07-13

Prograf
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2008-07-29
    End date: 2008-07-30

Prograf
    Dosage: 1.5 mg, unk
    Administration route: Oral
    Start date: 2008-09-28
    End date: 2008-10-02

Prograf
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2008-08-26
    End date: 2008-09-27

Other drugs received by patient: Mycophenolate Mofetil; Chemotherapeutics NOS; Pravastatin Sodium; Trandolapril; Prednisolone; Mycophenolate Mofetil; Steroids NOS; Pravastatin Sodium; Azathioprine Sodium; Candesartan Cilexetil; Mycophenolate Mofetil; Tacrolimus



Possible Neoral side effects in 74 year old male

Reported by a pharmacist from Japan on 2012-08-06

Patient: 74 year old male

Reactions: Capillary Disorder, Rash Macular

Drug(s) suspected as cause:
Neoral

Other drugs received by patient: Lansoprazole; Prednisolone; Allopurinol; Alendronate Sodium; Zolpidem



Possible Neoral side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-06

Patient: male, weighing 52.0 kg (114.4 pounds)

Reactions: Back Pain, Drug Resistance, Blood Triglycerides Increased, General Physical Health Deterioration, Neoplasm Progression, C-Reactive Protein Decreased, Kidney Transplant Rejection, Renal Failure Chronic, Post Transplant Lymphoproliferative Disorder, Renal Impairment

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Certican
    Dosage: 2 mg, unk
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 2007-07-13
    End date: 2007-07-23

Certican
    Dosage: 3 mg, unk
    Administration route: Oral
    Start date: 2007-07-24
    End date: 2007-07-27

Certican
    Dosage: 1.75 mg, unk
    Start date: 2008-08-01
    End date: 2008-08-24

Certican
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Start date: 2008-08-25
    End date: 2008-09-06

Certican
    Dosage: 2.75 mg, unk
    Administration route: Oral
    Start date: 2007-07-28
    End date: 2007-10-07

Certican
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Start date: 2007-10-08

Certican
    Dosage: 3.25 mg, unk
    Administration route: Oral
    Start date: 2008-09-28
    End date: 2009-06-05

Certican
    Dosage: 3 mg, unk
    Administration route: Oral
    Start date: 2009-06-06
    End date: 2009-07-18

Certican
    Dosage: 4.75 mg, unk
    Administration route: Oral
    Start date: 2009-11-13
    End date: 2010-03-02

Certican
    Dosage: 4.25 mg, daily
    Administration route: Oral
    Start date: 2009-08-22
    End date: 2009-09-03

Certican
    Dosage: 4.5 mg, daily
    Administration route: Oral
    Start date: 2009-09-04
    End date: 2009-11-12

Certican
    Dosage: 2.75 mg, unk
    Administration route: Oral
    Start date: 2008-09-07
    End date: 2008-09-27

Certican
    Dosage: 1.25 mg, unk
    Administration route: Oral
    Start date: 2008-07-30
    End date: 2008-07-30

Certican
    Dosage: 4 mg, unk
    Administration route: Oral
    Start date: 2009-07-19

Neoral
    Dosage: unk ukn, unk
    Indication: Renal Transplant
    Start date: 2001-01-01
    End date: 2006-01-01

Neoral
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Heart Transplant
    Start date: 1995-01-01
    End date: 2001-01-01

Prednisolone
    Dosage: 5 mg, unk
    Administration route: Oral
    Start date: 2008-07-30

Prograf
    Dosage: 3 mg, unk
    Administration route: Oral
    Start date: 2008-08-01
    End date: 2008-08-22

Prograf
    Dosage: 2.25 mg, unk
    Administration route: Oral
    Start date: 2008-08-23
    End date: 2008-08-25

Prograf
    Dosage: 2 mg, unk
    Administration route: Oral
    Start date: 2008-08-26
    End date: 2008-09-27

Prograf
    Dosage: 4 mg, unk
    Administration route: Oral
    Start date: 2002-02-19
    End date: 2007-07-12

Prograf
    Dosage: 3.5 mg, unk
    Administration route: Oral
    Start date: 2008-07-29
    End date: 2008-07-30

Prograf
    Dosage: 1.5 mg, unk
    Administration route: Oral
    Start date: 2008-09-28
    End date: 2008-10-02

Prograf
    Dosage: unk ukn, unk
    Administration route: Oral
    Start date: 2001-01-01
    End date: 2006-12-01

Prograf
    Dosage: 0.5 mg, unk
    Administration route: Oral
    Start date: 2007-07-13

Other drugs received by patient: Prednisolone; Tacrolimus; Mycophenolate Mofetil; Mycophenolate Mofetil; Azathioprine Sodium; Chemotherapeutics NOS; Trandolapril; Steroids NOS; Pravastatin Sodium; Mycophenolate Mofetil; Pravastatin Sodium; Candesartan Cilexetil



Possible Neoral side effects in male

Reported by a physician from Netherlands on 2012-08-03

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Hydronephrosis, Orthostatic Hypertension, Escherichia Urinary Tract Infection, Ureteric Stenosis, Oedema Peripheral, Hypertension, Thrombocytopenia, Leukopenia, Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myfortic
    Dosage: no treatment received
    Start date: 2012-02-12
    End date: 2012-02-21

Myfortic
    Dosage: 360 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-13
    End date: 2012-02-11

Myfortic
    Dosage: unk
    Administration route: Oral
    Start date: 2012-02-22
    End date: 2012-05-02

Neoral
    Dosage: 175 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-08-05
    End date: 2012-02-11

Neoral
    Dosage: unk
    Administration route: Oral
    Start date: 2012-02-22
    End date: 2012-05-02

Neoral
    Dosage: no treatment received
    Start date: 2012-02-12
    End date: 2012-02-21

Prednisolone
    Dosage: unk
    Start date: 2012-02-22
    End date: 2012-05-02

Prednisolone
    Dosage: 10 mg, bid
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2011-07-13
    End date: 2012-02-11

Prednisolone
    Dosage: no treatment received
    Start date: 2012-02-12
    End date: 2012-02-21

Other drugs received by patient: Lasix; Amlodipine; Calcium; Lipitor; Enalapril Maleate; Lisinopril; Mono-Cedocard; Valcyte; Calcium Carbonate; Nexium; Mono-Cedocard; Etalpha



Possible Neoral side effects in 37 year old female

Reported by a pharmacist from Japan on 2012-08-03

Patient: 37 year old female

Reactions: Hypoaesthesia

Drug(s) suspected as cause:
Lipitor

Neoral
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Dermatomyositis
    Start date: 2010-05-01

Sennoside A+B
    Dosage: 24 mg, daily
    Administration route: Oral
    Start date: 2012-06-13



Possible Neoral side effects in male

Reported by a lawyer from Denmark on 2012-08-03

Patient: male

Reactions: Quality of Life Decreased, Parkinson's Disease, Cognitive Disorder, Pyrexia, Pneumocystis Jiroveci Pneumonia, Fatigue, Balance Disorder, Cerebral Thrombosis, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cellcept
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2006-11-06

Neoral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2006-11-06



Possible Neoral side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-01

Patient: 44 year old male

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Neoral

Other drugs received by patient: Colchicine



Possible Neoral side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-01

Patient: 44 year old male

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Neoral

Other drugs received by patient: Colchicine



Possible Neoral side effects in

Reported by a pharmacist from Japan on 2012-08-01

Patient:

Reactions: Drug Level Fluctuating, Drug Interaction

Drug(s) suspected as cause:
Neoral

Other drugs received by patient possibly interacting with the suspect drug:
Antimicrobial



Possible Neoral side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-01

Patient: female

Reactions: Gingival Bleeding

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exjade
    Indication: Aplastic Anaemia
    Start date: 2012-02-01

Neoral
    Dosage: 1.3 ml, unk
    Start date: 2012-02-02

Other drugs received by patient: Factor GAL; Danazol



Possible Neoral side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-31

Patient: 60 year old male

Reactions: Neurotoxicity, CSF Protein Increased, Central Nervous System Lesion, Muscular Weakness, Toxicity To Various Agents, Hypoaesthesia, Hemiplegia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-31

Patient: 60 year old male

Reactions: Neurotoxicity, CSF Protein Increased, Central Nervous System Lesion, Muscular Weakness, Hemiplegia, Hypoaesthesia, Toxicity To Various Agents

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Neoral



Possible Neoral side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-31

Patient: 32 year old female

Reactions: Graft Versus Host Disease, Post Transplant Distal Limb Syndrome, Pain in Extremity, Immunosuppressant Drug Level Increased

Drug(s) suspected as cause:
Neoral
    Indication: Prophylaxis Against Graft Versus Host Disease

Neoral
    Indication: Stem Cell Transplant

Other drugs received by patient: Methotrexate



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