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Advagraf Side Effects

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Common Advagraf Side Effects


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

Transplant Rejection (4)
Death (3)
Diarrhoea (3)
Pneumonia (3)
Fall (3)
Incorrect Dose Administered (3)
Jugular Vein Thrombosis (2)
Overdose (2)
Neutropenia (2)
Renal Failure (2)
Multi-organ Failure (2)
Urinary Tract Infection (2)
Prostatic Obstruction (2)
Renal Failure Acute (2)
Blood Creatinine Increased (2)
Disease Recurrence (2)
Tubulointerstitial Nephritis (2)
Erythema (1)
Laceration (1)
Escherichia Infection (1)

➢ 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.

Advagraf Side Effects Reported to FDA



Advagraf Side Effect Report#9989292
Leukopenia, Lymphopenia, Neutropenia
This is a report of a 66-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: prophylaxis,cytomegalovirus infection, who was treated with Advagraf (dosage: 5 Mg, Uid/qd, start time:
Dec 10, 2013), combined with:
  • Rovalcyte (1 Df, Other)
  • Cellcept /01275102/
  • Sodium Bicarbonate
  • Humalog
  • Lantus
  • Previscan /00261401/
  • Solupred /00016201/
  • Lexomil
and developed a serious reaction and side effect(s): Leukopenia, Lymphopenia, Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Advagraf treatment in female patients, resulting in Leukopenia side effect. The patient was hospitalized.
Advagraf Side Effect Report#9970182
Disease Recurrence
This report suggests a potential Advagraf Disease Recurrence side effect(s) that can have serious consequences. A male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: liver transplant and used Advagraf (dosage: Unk) starting NS. After starting Advagraf the patient began experiencing various side effects, including: Disease RecurrenceAdditional drugs used concurrently: NA. Although Advagraf demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disease Recurrence, may still occur.
Advagraf Side Effect Report#9949523
Off Label Use, Exposure During Pregnancy, Heart Transplant Rejection, Premature Delivery
This Off Label Use problem was reported by a physician from ZA. A 28-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: heart transplant. On
Dec 05, 2013 this consumer started treatment with Advagraf (dosage: 4 Mg, Uid/qd). The following drugs were being taken at the same time: NA. When using Advagraf, the patient experienced the following unwanted symptoms/side effects: Off Label Use, Exposure During Pregnancy, Heart Transplant Rejection, Premature DeliveryAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Off Label Use, may become evident only after a product is in use by the general population.
Advagraf Side Effect Report#9939164
Liver Transplant
This Liver Transplant side effect was reported by a physician from FR. A female patient (weight:NA) experienced the following symptoms/conditions: liver transplant.The patient was prescribed Advagraf (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cellcept /01275102/
  • Corticosteroids
.After starting to take Advagraf the consumer reported adverse symptoms, such as: Liver TransplantThese side effects may potentially be related to Advagraf.
Advagraf Side Effect Report#9919164
This is a report of a 75-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: renal transplant,liver transplant, who was treated with Advagraf (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Advagraf treatment in male patients, resulting in Death side effect.
Advagraf Side Effect Report#9890860
Wrist Fracture, Fall
This report suggests a potential Advagraf Wrist Fracture side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: renal transplant and used Advagraf (dosage: 4 Mg, Uid/qd) starting NS. After starting Advagraf the patient began experiencing various side effects, including: Wrist Fracture, FallAdditional drugs used concurrently: NA. Although Advagraf demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Wrist Fracture, may still occur.
Advagraf Side Effect Report#9888044
Nephrotic Syndrome, Ascites, Renal Failure, Diarrhoea
This Nephrotic Syndrome problem was reported by a health professional from FR. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis against transplant rejection,hepatitis c. On
Apr 08, 2013 this consumer started treatment with Advagraf (dosage: 1 Mg, Uid/qd). The following drugs were being taken at the same time:
  • Incivo (1125 Mg, Bid)
When using Advagraf, the patient experienced the following unwanted symptoms/side effects: Nephrotic Syndrome, Ascites, Renal Failure, DiarrhoeaThe 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 Nephrotic Syndrome, may become evident only after a product is in use by the general population.
Advagraf Side Effect Report#9845285
Erythema, Burning Sensation, Pruritus
This Erythema side effect was reported by a physician from FR. A female patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Advagraf (drug dosage: 12 Mg, Uid/qd), which was initiated on
Feb 02, 2011. Concurrently used drugs:
  • Prograf (5.5 Mg, Bid)
  • Prednisone (12 Mg, Uid/qd)
  • Mycophenolate Mofetil (2 G, Bid)
.After starting to take Advagraf the consumer reported adverse symptoms, such as: Erythema, Burning Sensation, PruritusThese side effects may potentially be related to Advagraf.
Advagraf Side Effect Report#9845251
Spinal Fracture, Pelvic Fracture, Fall
This is a report of a 63-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: renal transplant, who was treated with Advagraf (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Spinal Fracture, Pelvic Fracture, Fall after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Advagraf treatment in female patients, resulting in Spinal Fracture side effect. The patient was hospitalized.
Advagraf Side Effect Report#9831959
Catheter Placement, Transplant Failure, Fluid Retention, Blood Glucose Decreased, Herpes Dermatitis, Blood Pressure Increased, Blood Creatinine Increased, Chronic Allograft Nephropathy
This report suggests a potential Advagraf Catheter Placement side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: renal transplant and used Advagraf (dosage: 10 Mg, Uid/qd) starting NS. After starting Advagraf the patient began experiencing various side effects, including: Catheter Placement, Transplant Failure, Fluid Retention, Blood Glucose Decreased, Herpes Dermatitis, Blood Pressure Increased, Blood Creatinine Increased, Chronic Allograft NephropathyAdditional drugs used concurrently:
  • Cyclophosphamide (Unk)
  • Prednisone (Unk)
The patient was hospitalized. Although Advagraf demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Catheter Placement, may still occur.
Advagraf Side Effect Report#9822256
Delusion, Aggression, Confusional State
This Delusion problem was reported by a pharmacist from FR. A 19-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: liver transplant. On NS this consumer started treatment with Advagraf (dosage: 2 Mg Uid/qd). The following drugs were being taken at the same time:
  • Cellcept /01275102/
  • Cellcept /01275102/
  • Delursan (Unk)
  • Magnesium (Unk)
  • Vitamin B1 (Unk)
  • Vitamin B6 (Unk)
  • Uvedose (Unk)
When using Advagraf, the patient experienced the following unwanted symptoms/side effects: Delusion, Aggression, Confusional StateThe 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 Delusion, may become evident only after a product is in use by the general population.
Advagraf Side Effect Report#9818196
Nephrostomy Tube Removal
This Nephrostomy Tube Removal side effect was reported by a physician from FR. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Advagraf (drug dosage: Unk), which was initiated on
Sep 07, 2013. Concurrently used drugs:
  • Omeprazole (Unk)
  • Cellcept /01275102/ (Unk)
  • Cortancyl (Unk)
  • Aranesp (Unk)
  • Mecir (Unk)
  • Amlor (Unk)
.After starting to take Advagraf the consumer reported adverse symptoms, such as: Nephrostomy Tube RemovalThese side effects may potentially be related to Advagraf. The patient was hospitalized.
Advagraf Side Effect Report#9818187
Arteriovenous Fistula Thrombosis
This is a report of a 52-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: prophylaxis against transplant rejection,immunosuppression,fungal infection,hypertension, who was treated with Advagraf (dosage: 4 Mg, Uid/qd, start time:
Sep 04, 2013), combined with:
  • Cellcept /01275102/ (Unk)
  • Triflucan (Unk)
  • Eupressyl /00631801/ (Unk)
  • Solumedrol (Unk)
  • Pravastatin (Unk)
  • Lercan (Unk)
and developed a serious reaction and side effect(s): Arteriovenous Fistula Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Advagraf treatment in male patients, resulting in Arteriovenous Fistula Thrombosis side effect. The patient was hospitalized.
Advagraf Side Effect Report#9813024
Abscess Drainage
This report suggests a potential Advagraf Abscess Drainage side effect(s) that can have serious consequences. A 40-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Advagraf (dosage: Unk) starting
Nov 21, 2013. After starting Advagraf the patient began experiencing various side effects, including: Abscess DrainageAdditional drugs used concurrently:
  • Cortancyl (Unk)
  • Mycophenolate Mofetil (Unk)
The patient was hospitalized. Although Advagraf demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abscess Drainage, may still occur.
Advagraf Side Effect Report#9813016
Embolism
This Embolism problem was reported by a physician from FR. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: immunosuppression. On
Apr 29, 2013 this consumer started treatment with Advagraf (dosage: Unk). The following drugs were being taken at the same time:
  • Cellcept /01275102/ (Unk)
  • Hyperium (Unk)
  • Atenolol (Unk)
  • Inexium /01479302/ (Unk)
  • Cortancyl (Unk)
  • Amoxicillin (Unk)
  • Bactrim (Unk)
When using Advagraf, the patient experienced the following unwanted symptoms/side effects: EmbolismThe 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 Embolism, may become evident only after a product is in use by the general population.
Advagraf Side Effect Report#9807861
Tubulointerstitial Nephritis
This Tubulointerstitial Nephritis side effect was reported by a consumer or non-health professional from FR. A 52-year-old male patient (weight:NA) experienced the following symptoms/conditions: prophylaxis against transplant rejection,immunosuppression,fungal infection,hypertension,dyslipidaemia.The patient was prescribed Advagraf (drug dosage: 5 Mg, Uid/qd), which was initiated on
Sep 04, 2013. Concurrently used drugs:
  • Cellcept /01275102/ (Unk)
  • Triflucan (Unk)
  • Eupressyl /00631801/ (Unk)
  • Pravastatine (Unk)
  • Lercan (Unk)
.After starting to take Advagraf the consumer reported adverse symptoms, such as: Tubulointerstitial NephritisThese side effects may potentially be related to Advagraf.
Advagraf Side Effect Report#9778476
Cerebral Vasoconstriction
This is a report of a 49-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Advagraf (dosage: NA, start time: 2011), combined with:
  • Rapamune
  • Previscan /00261401/ (Unk)
  • Coumadine (Unk)
and developed a serious reaction and side effect(s): Cerebral Vasoconstriction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Advagraf treatment in female patients, resulting in Cerebral Vasoconstriction side effect. The patient was hospitalized.
Advagraf Side Effect Report#9778471
Intestinal Infarction, Lung Disorder, Transplant Rejection
This report suggests a potential Advagraf Intestinal Infarction side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: liver transplant and used Advagraf (dosage: NA) starting NS. After starting Advagraf the patient began experiencing various side effects, including: Intestinal Infarction, Lung Disorder, Transplant RejectionAdditional drugs used concurrently:
  • Certican (Unk)
The patient was hospitalized. Although Advagraf demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intestinal Infarction, may still occur.
Advagraf Side Effect Report#9778459
Escherichia Infection, Beta Haemolytic Streptococcal Infection, Urinary Tract Infection, Pyrexia, Parathyroid Disorder
This Escherichia Infection problem was reported by a consumer or non-health professional from CA. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal transplant. On
May 11, 2012 this consumer started treatment with Advagraf (dosage: 8 Mg, Uid/qd). The following drugs were being taken at the same time: NA. When using Advagraf, the patient experienced the following unwanted symptoms/side effects: Escherichia Infection, Beta Haemolytic Streptococcal Infection, Urinary Tract Infection, Pyrexia, Parathyroid DisorderThe 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 Escherichia Infection, may become evident only after a product is in use by the general population.
Advagraf Side Effect Report#9774645
Pneumonia, Pulmonary Haemorrhage
This Pneumonia side effect was reported by a physician from TW. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Advagraf (drug dosage: NA), which was initiated on 2013. Concurrently used drugs: NA..After starting to take Advagraf the consumer reported adverse symptoms, such as: Pneumonia, Pulmonary HaemorrhageThese side effects may potentially be related to Advagraf. The patient was hospitalized.
Advagraf Side Effect Report#9772252
Multi-organ Failure, Necrosis, Scedosporium Infection, Brain Abscess, Neutropenia
This is a report of a 68-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: immunosuppression, who was treated with Advagraf (dosage: Unk, start time: NS), combined with:
  • Deflazacort (Unk)
  • Mycophenolate Mofetil (Unk)
  • Cotrimoxazole (Unk)
  • Insulin (Unk)
  • Iron (Unk)
  • Omeprazole (Unk)
and developed a serious reaction and side effect(s): Multi-organ Failure, Necrosis, Scedosporium Infection, Brain Abscess, Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Advagraf treatment in male patients, resulting in Multi-organ Failure side effect.
Advagraf Side Effect Report#9716197
Tubulointerstitial Nephritis
This report suggests a potential Advagraf Tubulointerstitial Nephritis side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: immunosuppression and used Advagraf (dosage: Unk) starting
Jul 05, 2013. After starting Advagraf the patient began experiencing various side effects, including: Tubulointerstitial NephritisAdditional drugs used concurrently:
  • Cellcept /01275102/ (Unk)
  • Gaviscon /01764601/ (Unk)
  • Pentacarinat (Unk)
  • Temerit (Unk)
  • Iperten (Unk)
  • Alfuzosin Hydrochloride (Unk)
  • Symbicort (Unk)
Although Advagraf demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tubulointerstitial Nephritis, may still occur.
Advagraf Side Effect Report#9700992
Wound Dehiscence
This Wound Dehiscence problem was reported by a physician from FR. A 40-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 22, 2013 this consumer started treatment with Advagraf (dosage: Unk). The following drugs were being taken at the same time:
  • Myfortic (Unk)
  • Cortancyl (Unk)
When using Advagraf, the patient experienced the following unwanted symptoms/side effects: Wound DehiscenceThe 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 Wound Dehiscence, may become evident only after a product is in use by the general population.
Advagraf Side Effect Report#9697569
Road Traffic Accident
This Road Traffic Accident side effect was reported by a health professional from CA. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Advagraf (drug dosage: Unk), which was initiated on 200908. Concurrently used drugs: NA..After starting to take Advagraf the consumer reported adverse symptoms, such as: Road Traffic AccidentThese side effects may potentially be related to Advagraf. The patient was hospitalized.
Advagraf Side Effect Report#9692989
Ankle Fracture, Fall
This is a report of a 61-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: renal transplant, who was treated with Advagraf (dosage: 3 Mg, Uid/qd, start time: 201211), combined with: NA. and developed a serious reaction and side effect(s): Ankle Fracture, Fall after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Advagraf treatment in female patients, resulting in Ankle Fracture side effect.


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The appearance of Advagraf 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.

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  • 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.

    Advagraf 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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    Side Effects reported to FDA: 68

    Advagraf safety alerts: No

    Reported deaths: 7

    Reported hospitalizations: 39

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