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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
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 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 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 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 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
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 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 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
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 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 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 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 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 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
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 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 female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31
Patient: female
Reactions: Hypotension, Oedema, Immunosuppressant Drug Level Increased, Asthenia, Leukopenia, Anaemia Macrocytic
Drug(s) suspected as cause:
Bactrim DS
Dosage: unk ukn, unk
Administration route: Oral
Indication: Infection in AN Immunocompromised Host
Start date: 2011-04-08
End date: 2011-08-29
Cellcept
Dosage: 1.5 g, bid (morning and evening)
Administration route: Oral
Start date: 2011-08-29
Cellcept
Dosage: 1750 mg, bid (morning and evening)
Administration route: Oral
Start date: 2011-07-20
Cellcept
Administration route: Oral
Indication: Immunosuppression
Start date: 2011-04-08
Certican
Administration route: Oral
Indication: Immunosuppression
Start date: 2011-05-09
Certican
Dosage: (0.5 mg in the morning and 0.25 mg in the evening)
Administration route: Oral
Start date: 2011-07-18
Certican
Dosage: 0.5 mg, bid
Administration route: Oral
Start date: 2012-01-11
Certican
Dosage: 0.25 mg, bid
Administration route: Oral
Start date: 2011-06-20
Neoral
Dosage: (100 mg in morning and 75 mg in evening)
Neoral
Dosage: 50 mg, bid
Valganciclovir
Indication: Cytomegalovirus Infection
Start date: 2011-04-08
End date: 2012-01-11
Other drugs received by patient: Pravastatin; Folic Acid; Aranesp; Ferrous Fumarate; Amlodipine Besylate; Thymoglobulin; Fungizone; Corticosteroids; Aspirin; Prednisolone; Esomeprazole; Prograf; Sporanox; Ramipril; Bactrim
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
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