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Neoral Side Effects

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Common Neoral Side Effects


The most commonly reported Neoral side effects (click to view or check a box to report):

Blood Creatinine Increased (291)
Pyrexia (159)
Renal Impairment (137)
Renal Failure Acute (113)
Cytomegalovirus Infection (106)
Hypertension (102)
Nephropathy Toxic (93)
Headache (91)
Dyspnoea (89)
Anaemia (85)
Kidney Transplant Rejection (82)
Abdominal Pain (75)
Blood Lactate Dehydrogenase Increased (74)
Renal Failure (74)
Diarrhoea (71)
Pneumonia (70)
Sepsis (68)
C-reactive Protein Increased (66)
Pancytopenia (65)
Dehydration (64)

➢ 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.

Neoral Side Effects Reported to FDA



Neoral Side Effect Report#9999729
Acrochordon
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Neoral (dosage: NA, start time: NS), combined with:
  • Prednisone
  • Cellcept (mycophenolate Mofetil)
  • Atenolol
  • Diovan (valsartan)
  • Norvasc (amlodipine Besilate)
  • Celexa (citalopram Hydrobromide)
  • Bactrim Ds (sulfamethoxazole, Trimethoprim)
  • Omeprazole
and developed a serious reaction and side effect(s): Acrochordon after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Neoral treatment in male patients, resulting in Acrochordon side effect.
Neoral Side Effect Report#9999728
Renal Failure, Infection
This report suggests a potential Neoral Renal Failure side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Neoral (dosage: Six Times Daily) starting NS. After starting Neoral the patient began experiencing various side effects, including: Renal Failure, InfectionAdditional drugs used concurrently:
  • Clonidine
  • Aspirin (acetylsalicylic Acid)
  • Lipitor (atorvastatin Calcium)
  • Losartin (losartan Potassium)
  • Hydrazine
  • Atenolol
  • Ciclosporin
Although Neoral demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure, may still occur.
Neoral Side Effect Report#9999719
Renal Failure
This Renal Failure problem was reported by a consumer or non-health professional from US. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Neoral (dosage: NA). The following drugs were being taken at the same time:
  • Crestor (rosuvastin Calcium)
  • Cozaar (losartan Potassium) (50 Milligram, Tablets) (losartan Potassium)
  • Zemplar (paricalcitol)
  • Prevacid (lansoprazole)
  • Sodium Bicarbonate (sodium Bicarbonate)
When using Neoral, the patient experienced the following unwanted symptoms/side effects: Renal FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure, may become evident only after a product is in use by the general population.
Neoral Side Effect Report#9999708
Nephropathy Toxic
This Nephropathy Toxic side effect was reported by a consumer or non-health professional from US. A 50-year-old female patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Neoral (drug dosage: NA), which was initiated on 201012. Concurrently used drugs:
  • Rapamune (sirolimus)
  • Aspirin (acetylsalicylic Acid)
  • Ferra Sulfate (ferrous Sulfate)
  • Bactrim (sulfamethoxazole, Trimethoprim)
  • Amlodipine (amlodipine)
  • Metoprolol (metoprolol)
  • Estrogen (estradiol)
  • Vitamin C (ascorbic Acid)
.After starting to take Neoral the consumer reported adverse symptoms, such as: Nephropathy ToxicThese side effects may potentially be related to Neoral.
Neoral Side Effect Report#9999669
Bronchitis, Renal Failure
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: renal transplant, who was treated with Neoral (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Bronchitis, Renal Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Neoral treatment in female patients, resulting in Bronchitis side effect. The patient was hospitalized.
Neoral Side Effect Report#9999668
Breast Cancer
This report suggests a potential Neoral Breast Cancer side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: renal transplant and used Neoral (dosage: NA) starting
Sep 03, 2010. After starting Neoral the patient began experiencing various side effects, including: Breast CancerAdditional drugs used concurrently: NA. Although Neoral demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Breast Cancer, may still occur.
Neoral Side Effect Report#9999638
Diarrhoea, Dehydration, Abdominal Discomfort
This Diarrhoea problem was reported by a physician from US. A 42-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: renal transplant. On NS this consumer started treatment with Neoral (dosage: NA). The following drugs were being taken at the same time: NA. When using Neoral, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Dehydration, Abdominal DiscomfortThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diarrhoea, may become evident only after a product is in use by the general population.
Neoral Side Effect Report#9999632
Renal Failure
This Renal Failure side effect was reported by a consumer or non-health professional from US. A 39-year-old male patient (weight:NA) experienced the following symptoms/conditions: heart transplant.The patient was prescribed Neoral (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Neoral the consumer reported adverse symptoms, such as: Renal FailureThese side effects may potentially be related to Neoral. The patient was hospitalized.
Neoral Side Effect Report#9999631
Herpes Zoster
This is a report of a 48-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: heart and lung transplant, who was treated with Neoral (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Herpes Zoster after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Neoral treatment in male patients, resulting in Herpes Zoster side effect. The patient was hospitalized.
Neoral Side Effect Report#9995702
Contusion
This report suggests a potential Neoral Contusion side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: heart transplant and used Neoral (dosage: 3 Caps Every 12 Hrs Oral) starting 200906. After starting Neoral the patient began experiencing various side effects, including: ContusionAdditional drugs used concurrently:
  • Myfortic (2 Tab Bid)
  • Amaryl
  • Avapro
  • Cardizem
  • Ferrous Sulfate
  • Folic Acid
  • Lasix
  • Lipitor
Although Neoral demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Contusion, may still occur.
Neoral Side Effect Report#9994876
Renal Cyst, Tubulointerstitial Nephritis, Clear Cell Renal Cell Carcinoma
This Renal Cyst problem was reported by a physician from FR. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis against transplant rejection. On
Oct 23, 2012 this consumer started treatment with Neoral (dosage: 170 Mg, Unk). The following drugs were being taken at the same time:
  • Cortancyl (5 Mg, Unk)
  • Cellcept (1000 Mg, Unk)
When using Neoral, the patient experienced the following unwanted symptoms/side effects: Renal Cyst, Tubulointerstitial Nephritis, Clear Cell Renal Cell CarcinomaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Cyst, may become evident only after a product is in use by the general population.
Neoral Side Effect Report#9993494
Liver Disorder, Hepatocellular Carcinoma
This Liver Disorder side effect was reported by a pharmacist from JP. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: psoriasis.The patient was prescribed Neoral (drug dosage: 200 Mg, Daily), which was initiated on NS. Concurrently used drugs: NA..After starting to take Neoral the consumer reported adverse symptoms, such as: Liver Disorder, Hepatocellular CarcinomaThese side effects may potentially be related to Neoral. The patient was hospitalized.
Neoral Side Effect Report#9986958
Blood Creatinine Increased, Accidental Overdose
This is a report of a 7-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: crohn^s disease, who was treated with Neoral (dosage: 0.6 Ml, Bid, start time: 201307), combined with: NA. and developed a serious reaction and side effect(s): Blood Creatinine Increased, Accidental Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Neoral treatment in male patients, resulting in Blood Creatinine Increased side effect. The patient was hospitalized.
Neoral Side Effect Report#9983741
This report suggests a potential Neoral Death side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Neoral (dosage: 25 Mg, Unk) starting NS. After starting Neoral the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Neoral demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Neoral Side Effect Report#9951859
Autoimmune Haemolytic Anaemia
This Autoimmune Haemolytic Anaemia problem was reported by a pharmacist from JP. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: interstitial lung disease,off label use,dermatitis exfoliative. On NS this consumer started treatment with Neoral (dosage: 150 Mg, 100 Mg In The Morning And 50 Mg In The Early Evening). The following drugs were being taken at the same time: NA. When using Neoral, the patient experienced the following unwanted symptoms/side effects: Autoimmune Haemolytic AnaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Autoimmune Haemolytic Anaemia, may become evident only after a product is in use by the general population.
Neoral Side Effect Report#9944038
This Death side effect was reported by a health professional from GB. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Neoral (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Neoral the consumer reported adverse symptoms, such as: These side effects may potentially be related to Neoral.
Neoral Side Effect Report#9943332
Urinary Retention, Renal Failure Acute
This is a report of a 67-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: bone marrow failure, who was treated with Neoral (dosage: 500 Mg, Qd, start time: 201208), combined with:
  • Danatrol (400 Mg, Qd)
  • Lepticur (10 Mg, Qd)
  • Haldol (5 Mg, Bid)
  • Largactil (100 Mg, Bid)
and developed a serious reaction and side effect(s): Urinary Retention, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Neoral treatment in male patients, resulting in Urinary Retention side effect. The patient was hospitalized.
Neoral Side Effect Report#9934915
Dehydration, Renal Failure Acute, Atypical Pneumonia
This report suggests a potential Neoral Dehydration side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: liver transplant and used Neoral (dosage: 100 Mg, Bid) starting NS. After starting Neoral the patient began experiencing various side effects, including: Dehydration, Renal Failure Acute, Atypical PneumoniaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Neoral demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dehydration, may still occur.
Neoral Side Effect Report#9933909
Myocarditis, Oedema, Troponin I Increased, Ventricular Extrasystoles, Cardiac Ventricular Thrombosis, Disease Progression
This Myocarditis problem was reported by a health professional from IT. A 38-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: immunosuppression. On NS this consumer started treatment with Neoral (dosage: NA). The following drugs were being taken at the same time:
  • Everolimus (0.25 Mg, Unk)
  • Methylprednisolone (1.5 Mg/kg, Per Day)
  • Methylprednisolone (1 G, Unk)
  • Azathioprine
  • Mycophenolate
  • Prednisone
  • Diuretics
  • Ace Inhibitors
When using Neoral, the patient experienced the following unwanted symptoms/side effects: Myocarditis, Oedema, Troponin I Increased, Ventricular Extrasystoles, Cardiac Ventricular Thrombosis, Disease ProgressionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocarditis, may become evident only after a product is in use by the general population.
Neoral Side Effect Report#9929719
Diabetic Complication, Diabetes Mellitus Inadequate Control
This Diabetic Complication side effect was reported by a pharmacist from JP. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: aplastic anaemia.The patient was prescribed Neoral (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Neoral the consumer reported adverse symptoms, such as: Diabetic Complication, Diabetes Mellitus Inadequate ControlThese side effects may potentially be related to Neoral.
Neoral Side Effect Report#9929716
Rectal Ulcer, Large Intestinal Ulcer
This is a report of a 53-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: systemic lupus erythematosus,off label use, who was treated with Neoral (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Rectal Ulcer, Large Intestinal Ulcer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Neoral treatment in female patients, resulting in Rectal Ulcer side effect.
Neoral Side Effect Report#9919994
Renal Disorder, Pyrexia
This report suggests a potential Neoral Renal Disorder side effect(s) that can have serious consequences. A 78-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: aplastic anaemia and used Neoral (dosage: 100 Mg, Daily) starting
Nov 21, 2013. After starting Neoral the patient began experiencing various side effects, including: Renal Disorder, PyrexiaAdditional drugs used concurrently:
  • Predonine (10 Mg, Unk)
  • Primobolan (20 Mg, Unk)
  • Corticosteroids (Unk Ukn, Unk)
  • Hormones (Unk Ukn, Unk)
Although Neoral demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Disorder, may still occur.
Neoral Side Effect Report#9919736
Arthralgia, Osteonecrosis
This Arthralgia problem was reported by a health professional from FR. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 09, 2012 this consumer started treatment with Neoral (dosage: 100 Mg, Bid). The following drugs were being taken at the same time:
  • Cellcept (3000 Mg, Qd)
  • Solupred (5 Mg, Qd)
When using Neoral, the patient experienced the following unwanted symptoms/side effects: Arthralgia, OsteonecrosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthralgia, may become evident only after a product is in use by the general population.
Neoral Side Effect Report#9914979
Tonic Convulsion
This Tonic Convulsion side effect was reported by a health professional from FR. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: angiolymphoid hyperplasia with eosinophilia,malaria prophylaxis.The patient was prescribed Neoral (drug dosage: 100 Mg, Qd), which was initiated on
Oct 24, 2013. Concurrently used drugs:
  • Doxycycline (100 Mg, Qd)
.After starting to take Neoral the consumer reported adverse symptoms, such as: Tonic ConvulsionThese side effects may potentially be related to Neoral.
Neoral Side Effect Report#9911603
Burkitt^s Lymphoma, Lymph Node Pain, Lymphadenopathy, Pyrexia, Neck Pain, Diffuse Large B-cell Lymphoma, Local Swelling, Epstein-barr Virus Infection, Epstein-barr Virus Antigen Positive
This is a report of a 42-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: myasthenia gravis, who was treated with Neoral (dosage: 200 Mg, Qd, start time: 200807), combined with: NA. and developed a serious reaction and side effect(s): Burkitt^s Lymphoma, Lymph Node Pain, Lymphadenopathy, Pyrexia, Neck Pain, Diffuse Large B-cell Lymphoma, Local Swelling, Epstein-barr Virus Infection, Epstein-barr Virus Antigen Positive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Neoral treatment in male patients, resulting in Burkitt^s Lymphoma side effect. The patient was hospitalized.


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The appearance of Neoral 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.

What are common Neoral Side Effects for Women?

Women Side EffectsReports
Blood Creatinine Increased 75
Pyrexia 62
Renal Impairment 53
Dyspnoea 40
Kidney Transplant Rejection 39
Abdominal Pain 38
Cytomegalovirus Infection 38
Headache 38
Diarrhoea 35
Hypertension 34

What are common Neoral Side Effects for Men?

Men Side EffectsReports
Blood Creatinine Increased 210
Pyrexia 95
Renal Failure Acute 83
Renal Impairment 81
Nephropathy Toxic 69
Cytomegalovirus Infection 68
Hypertension 68
Anaemia 53
Headache 51
Dyspnoea 48

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    Neoral 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.

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    Neoral Safety Alerts, Active Ingredients, Usage Information

    NDC0078-0246
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameNeoral
    Namecyclosporine
    Dosage FormCAPSULE, LIQUID FILLED
    RouteORAL
    On market since19950714
    LabelerNovartis Pharmaceuticals Corporation
    Active Ingredient(s)CYCLOSPORINE
    Strength(s)25
    Unit(s)mg/1
    Pharma ClassCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhib

    Neoral Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2594

    Neoral safety alerts: No

    Reported deaths: 592

    Reported hospitalizations: 1634

    Latest Neoral clinical trials

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