Prograft Side Effects

Common Prograft Side Effects

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

Graft Versus Host Disease (2)
Leukopenia (2)
Liver Disorder (1)
Abdominal Pain (1)
Off Label Use (1)
Bronchopulmonary Aspergillosis (1)
Clostridium Difficile Infection (1)
Disseminated Intravascular Coagulation (1)
Diarrhoea (1)
Diabetes Mellitus (1)
Toxicity To Various Agents (1)
Suicide Attempt (1)
Pneumocystis Jirovecii Pneumonia (1)
Parkinson^s Disease (1)
Overdose (1)
Post Transplant Lymphoproliferative Disorder (1)
Pyrexia (1)
Respiratory Failure (1)
Renal Impairment (1)
Thrombocytopenia (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.

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.

Prograft Side Effects Reported to FDA

The following Prograft 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.

The appearance of Prograft 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.
Post Transplant Lymphoproliferative Disorder, Epstein-barr Virus Infection, Clostridium Difficile Infection, Diarrhoea, Weight Decreased, Leukopenia, Diabetes Mellitus, Pyrexia, Abdominal Pain
This is a report of a 26-year-old male patient (weight: NA) from BE, suffering from the following symptoms/conditions: immunosuppression, who was treated with Prograft (dosage: 11 Mg, Bid, start time: NS), combined with:
  • Cellcept /01275102/ (250 Mg, Bid)
  • Medrol /00049601/
  • Medrol /00049601/
  • Rituximab (Unk)
  • Nystatin (Unk)
  • Simvastatin (Unk)
  • Calcium Carbonate (Unk)
  • Alfacalcidol (Unk)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Post Transplant Lymphoproliferative Disorder
  • Epstein-barr Virus Infection
  • Clostridium Difficile Infection
  • Diarrhoea
  • Weight Decreased
  • Leukopenia
  • Diabetes Mellitus
  • Pyrexia
  • Abdominal Pain
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prograft treatment in male patients, resulting in post transplant lymphoproliferative disorder side effect. The patient was hospitalized.

Parkinson^s Disease
This report suggests a potential Prograft Parkinson^s Disease side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from NL was diagnosed with the following symptoms/conditions: lung transplant and used Prograft (dosage: 3 Mg, Bid) starting Apr 12, 2007. Soon after starting Prograft the patient began experiencing various side effects, including:
  • Parkinson^s Disease
Drugs used concurrently:
  • Cellcept /01275102/ (500 Mg, Bid)
  • Prednisone (Unk Mg, Uid/qd)
  • Cotrimoxazole (Unk)
  • Pantoprazole (40 Mg, Bid)
Although Prograft demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as parkinson^s disease, may still occur.

Off Label Use, Respiratory Failure, Pneumocystis Jirovecii Pneumonia, Bronchopulmonary Aspergillosis, Graft Versus Host Disease, Thrombocytopenia, Leukopenia, Disseminated Intravascular Coagulation, Toxicity To Various Agents
This Off Label Use, Respiratory Failure, Pneumocystis Jirovecii Pneumonia, Bronchopulmonary Aspergillosis, Graft Versus Host Disease, Thrombocytopenia, Leukopenia, Disseminated Intravascular Coagulation, Toxicity To Various Agents problem was reported by a health professional from BE. A 45-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic graft versus host disease. On Mar 16, 2007 this consumer started treatment with Prograft (dosage: Unk). The following drugs were being taken at the same time:
  • Imuran /00001501/ (Unk)
  • Medrol /00049601/ (Unk)
  • Omeprazole (20 Mg, Uid/qd)
  • Zyrtec (Unk)
  • Stilnoct (3 Torr, Tid)
  • Contramal (100 Mg, Prn)
When commencing Prograft, the patient experienced the following unwanted symptoms/side effects:
  • Off Label Use
  • Respiratory Failure
  • Pneumocystis Jirovecii Pneumonia
  • Bronchopulmonary Aspergillosis
  • Graft Versus Host Disease
  • Thrombocytopenia
  • Leukopenia
  • Disseminated Intravascular Coagulation
  • Toxicity To Various Agents
Although 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.

Overdose, Renal Impairment, Suicide Attempt
This is a report of a 54-year-old male patient (weight: NA) from BELGIUM. The patient developed the following symptoms/conditions: liver transplant and was treated with Prograft(tacrolimus) Capsule (dosage: 0.5 Mg, Weekly,) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Overdose
  • Renal Impairment
  • Suicide Attempt
The patient was hospitalized. This opens a possibility that Prograft(tacrolimus) Capsule treatment could cause the above reactions, including overdose, and some male subjects may be more susceptible.

Encephalitis Herpes, Graft Versus Host Disease, Hepatic Failure, Hepatic Necrosis, Liver Disorder
A 37-year-old female patient (weight: NA) from JAPAN with the following symptoms/conditions: bone marrow transplant started Prograft(tacrolimus) Formulation treatment (dosage: NA) on NS. Soon after starting Prograft(tacrolimus) Formulation treatment, the subject experienced various side effects, including:
  • Encephalitis Herpes
  • Graft Versus Host Disease
  • Hepatic Failure
  • Hepatic Necrosis
  • Liver Disorder
Concurrently used drugs:
  • Methotrexate
This finding indicates that some female patients could be more vulnerable to Prograft(tacrolimus) Formulation.

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.

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    More About Prograft

    Side Effects reported to FDA: 5

    Prograft safety alerts: No

    Reported deaths: 3

    Reported hospitalizations: 1

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