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Tacrolimus Side Effects

PatientsVille

Common Tacrolimus Side Effects


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

Off Label Use (158)
Death (158)
Blood Creatinine Increased (139)
Diarrhoea (126)
Pyrexia (122)
Renal Impairment (116)
Pneumonia (111)
Condition Aggravated (103)
Cytomegalovirus Infection (91)
Renal Failure Acute (81)
Transplant Rejection (77)
Abdominal Pain (74)
Thrombotic Microangiopathy (69)
Hypertension (68)
Convulsion (68)
Vomiting (66)
Renal Failure (65)
Sepsis (64)
Nausea (59)
Graft Versus Host Disease (59)

➢ 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.

Tacrolimus Side Effects Reported to FDA



Tacrolimus Side Effect Report#9999282
Thrombotic Microangiopathy
This is a report of a 45-year-old male patient (weight: NA) from IN, suffering from the following health symptoms/conditions: renal transplant, who was treated with Tacrolimus (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Thrombotic Microangiopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tacrolimus treatment in male patients, resulting in Thrombotic Microangiopathy side effect.
Tacrolimus Side Effect Report#9995275
Impaired Healing
This report suggests a potential Tacrolimus Sustained-release Capsules Impaired Healing side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: prophylaxis against transplant rejection,immunosuppression and used Tacrolimus Sustained-release Capsules (dosage: Unk) starting
Jan 28, 2014. After starting Tacrolimus Sustained-release Capsules the patient began experiencing various side effects, including: Impaired HealingAdditional drugs used concurrently:
  • Atg-fresenius S (110 Mg, Uid/qd)
  • Cellcept /01275102/ (Unk)
  • Solu-medrol (Unk)
  • Medrol /00049601/ (Unk)
  • Valsartan (80 Mg, Uid/qd)
The patient was hospitalized. Although Tacrolimus Sustained-release Capsules demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Impaired Healing, may still occur.
Tacrolimus Side Effect Report#9993594
Inappropriate Antidiuretic Hormone Secretion
This Inappropriate Antidiuretic Hormone Secretion problem was reported by a health professional from JP. A 20-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis against graft versus host disease. On NS this consumer started treatment with Tacrolimus (dosage: 0.03mg/kg/d (1.5mg/d); Continuous Infusion Starting On Day -1). The following drugs were being taken at the same time:
  • Mycophenolate Mofetil (25mg/kg/d (1500mg/d); 3 Times A Day Starting On Day 0)
  • Fluconazole
  • Ursodeoxycholic Acid
  • Prednisolone (1mg/kg)
  • Cyclophosphamide (120mg/kg)
When using Tacrolimus, the patient experienced the following unwanted symptoms/side effects: Inappropriate Antidiuretic Hormone SecretionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Inappropriate Antidiuretic Hormone Secretion, may become evident only after a product is in use by the general population.
Tacrolimus Side Effect Report#9982544
Skin Discolouration
This Skin Discolouration side effect was reported by a health professional from US. A 45-year-old male patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Tacrolimus (drug dosage: NA), which was initiated on
Nov 26, 2013. Concurrently used drugs: NA..After starting to take Tacrolimus the consumer reported adverse symptoms, such as: Skin DiscolourationThese side effects may potentially be related to Tacrolimus.
Tacrolimus Side Effect Report#9981145
Diabetic Ketoacidosis, Diabetic Ketoacidosis, Renal Injury
This is a report of a 57-year-old male patient (weight: NA) from CA, suffering from the following health symptoms/conditions: renal transplant,impaired gastric emptying, who was treated with Tacrolimus Mr4 Capsules (dosage: 4 Mg, Uid/qd, start time: 2010), combined with:
  • Domperidone (Unk)
and developed a serious reaction and side effect(s): Diabetic Ketoacidosis, Diabetic Ketoacidosis, Renal Injury after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tacrolimus Mr4 Capsules treatment in male patients, resulting in Diabetic Ketoacidosis side effect. The patient was hospitalized.
Tacrolimus Side Effect Report#9981103
Guillain-barre Syndrome
This report suggests a potential Tacrolimus Systemic Guillain-barre Syndrome side effect(s) that can have serious consequences. A 44-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: immunosuppression and used Tacrolimus Systemic (dosage: Unk) starting NS. After starting Tacrolimus Systemic the patient began experiencing various side effects, including: Guillain-barre SyndromeAdditional drugs used concurrently:
  • Mycophenolate Mofetil (Unk)
  • Methylprednisolone (500 Mg, Cyclic)
  • Basiliximab (Unk)
  • Co-trimoxazole (Unk)
  • Nystatin (Unk)
  • Lansoprazole
  • Amlodipine
  • Doxazosin
Although Tacrolimus Systemic demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Guillain-barre Syndrome, may still occur.
Tacrolimus Side Effect Report#9969991
Acute Hepatic Failure, Hepatic Fibrosis, Hepatic Cirrhosis, Non-alcoholic Steatohepatitis
This Acute Hepatic Failure problem was reported by a health professional from AT. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal transplant. On NS this consumer started treatment with Tacrolimus (dosage: NA). The following drugs were being taken at the same time:
  • Mycophenolate
  • Prednisolone
When using Tacrolimus, the patient experienced the following unwanted symptoms/side effects: Acute Hepatic Failure, Hepatic Fibrosis, Hepatic Cirrhosis, Non-alcoholic SteatohepatitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Acute Hepatic Failure, may become evident only after a product is in use by the general population.
Tacrolimus Side Effect Report#9969988
Acute Hepatic Failure, Hepatic Fibrosis, Hepatic Cirrhosis, Non-alcoholic Steatohepatitis
This Acute Hepatic Failure side effect was reported by a health professional from AT. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Tacrolimus (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Mycophenolate
  • Prednisolone
.After starting to take Tacrolimus the consumer reported adverse symptoms, such as: Acute Hepatic Failure, Hepatic Fibrosis, Hepatic Cirrhosis, Non-alcoholic SteatohepatitisThese side effects may potentially be related to Tacrolimus.
Tacrolimus Side Effect Report#9969987
Acute Hepatic Failure, Hepatic Fibrosis, Hepatic Cirrhosis, Non-alcoholic Steatohepatitis
This is a report of a 56-year-old male patient (weight: NA) from AT, suffering from the following health symptoms/conditions: renal transplant, who was treated with Tacrolimus (dosage: NA, start time: NS), combined with:
  • Mycophenolate
  • Prednisolone
and developed a serious reaction and side effect(s): Acute Hepatic Failure, Hepatic Fibrosis, Hepatic Cirrhosis, Non-alcoholic Steatohepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tacrolimus treatment in male patients, resulting in Acute Hepatic Failure side effect.
Tacrolimus Side Effect Report#9961429
Vesicoureteric Reflux
This report suggests a potential Tacrolimus Mr4 Capsules Vesicoureteric Reflux side effect(s) that can have serious consequences. A 73-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: prophylaxis against transplant rejection,immunosuppression,hypertension,hypocalcaemia and used Tacrolimus Mr4 Capsules (dosage: 4 Mg, Uid/qd) starting
Jul 23, 2013. After starting Tacrolimus Mr4 Capsules the patient began experiencing various side effects, including: Vesicoureteric RefluxAdditional drugs used concurrently:
  • Cellcept /01275102/ (Unk)
  • Avlocardyl /00030001/ (Unk)
  • Calcidia (Unk)
  • Amlor (Unk)
  • Levothyrox (Unk)
  • Gaviscon /02804301/ (Unk)
The patient was hospitalized. Although Tacrolimus Mr4 Capsules demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vesicoureteric Reflux, may still occur.
Tacrolimus Side Effect Report#9939233
Catheter Removal, Catheter Removal
This Catheter Removal problem was reported by a consumer or non-health professional from FR. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: immunosuppression. On
Jun 07, 2013 this consumer started treatment with Tacrolimus Mr4 Capsules (dosage: Unk). The following drugs were being taken at the same time:
  • Cellcept /01275102/ (Unk)
  • Solupred /00016201/ (Unk)
  • Pentacarinat (Unk)
  • Calcidia (Unk)
  • Dafalgan (Unk)
  • Domperidone (Unk)
  • Inexium /01479302/ (Unk)
  • Forlax /00754501/ (Unk)
When using Tacrolimus Mr4 Capsules, the patient experienced the following unwanted symptoms/side effects: Catheter Removal, Catheter RemovalThe 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 Catheter Removal, may become evident only after a product is in use by the general population.
Tacrolimus Side Effect Report#9939135
Catheter Removal, Catheter Removal
This Catheter Removal side effect was reported by a physician from FR. A 24-year-old male patient (weight:NA) experienced the following symptoms/conditions: immunosuppression.The patient was prescribed Tacrolimus Mr4 Capsules (drug dosage: Unk), which was initiated on
Jun 27, 2013. Concurrently used drugs:
  • Cellcept /01275102/ (Unk)
  • Inexium /01479302/ (Unk)
  • Amlor (Unk)
  • Zovirax /00587301/ (Unk)
  • Temerit (Unk)
  • Pentacarinat (Unk)
.After starting to take Tacrolimus Mr4 Capsules the consumer reported adverse symptoms, such as: Catheter Removal, Catheter RemovalThese side effects may potentially be related to Tacrolimus Mr4 Capsules. The patient was hospitalized.
Tacrolimus Side Effect Report#9939118
Catheter Removal, Catheter Removal
This is a report of a 42-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: immunosuppression, who was treated with Tacrolimus Mr4 Capsules (dosage: Unk, start time:
Jul 12, 2013), combined with:
  • Cellcept /01275102/ (Unk)
  • Pantestone /00103107/ (Unk)
  • Inexium /01479302/ (Unk)
  • Zovirax /00587301/ (Unk)
  • Tardyferon (Unk)
  • Pentacarinat (Unk)
  • Xanax (Unk)
and developed a serious reaction and side effect(s): Catheter Removal, Catheter Removal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tacrolimus Mr4 Capsules treatment in male patients, resulting in Catheter Removal side effect. The patient was hospitalized.
Tacrolimus Side Effect Report#9938053
Post Transplant Distal Limb Syndrome
This report suggests a potential Tacrolimus Post Transplant Distal Limb Syndrome side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: immunosuppression and used Tacrolimus (dosage: (3 Mg In?morning And 2.5 Mg In Evening) starting NS. After starting Tacrolimus the patient began experiencing various side effects, including: Post Transplant Distal Limb SyndromeAdditional drugs used concurrently:
  • Prednisone
Although Tacrolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Post Transplant Distal Limb Syndrome, may still occur.
Tacrolimus Side Effect Report#9924487
Asthma
This Asthma problem was reported by a consumer or non-health professional from NL. A 7.-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: dermatitis atopic,asthma. On
Feb 15, 2008 this consumer started treatment with Tacrolimus Ointment (dosage: NA). The following drugs were being taken at the same time:
  • Flixotide (250 Ug, Bid)
  • Ventolin /00139501/ (100 Ug, 6dd1-2)
  • A. Vogel Cinuforce (Unk)
  • Triamcinolone Acetonide (Unk)
When using Tacrolimus Ointment, the patient experienced the following unwanted symptoms/side effects: AsthmaThe 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 Asthma, may become evident only after a product is in use by the general population.
Tacrolimus Side Effect Report#9920222
Overdose
This Overdose side effect was reported by a health professional from FR. A 61-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tacrolimus (drug dosage: 2 Mg, Per Day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Tacrolimus the consumer reported adverse symptoms, such as: OverdoseThese side effects may potentially be related to Tacrolimus.
Tacrolimus Side Effect Report#9920221
Overdose
This is a report of a 53-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Tacrolimus (dosage: 5 Mg, Per Day, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tacrolimus treatment in male patients, resulting in Overdose side effect.
Tacrolimus Side Effect Report#9915678
Guillain-barre Syndrome
This report suggests a potential Tacrolimus Guillain-barre Syndrome side effect(s) that can have serious consequences. A 44-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: immunosuppression and used Tacrolimus (dosage: NA) starting NS. After starting Tacrolimus the patient began experiencing various side effects, including: Guillain-barre SyndromeAdditional drugs used concurrently:
  • Basiliximab
  • Methylprednisolone
  • Mycophenolic Acid
Although Tacrolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Guillain-barre Syndrome, may still occur.
Tacrolimus Side Effect Report#9913602
Clostridium Difficile Infection, Guillain-barre Syndrome
This Clostridium Difficile Infection problem was reported by a health professional from US. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: heart transplant. On NS this consumer started treatment with Tacrolimus (dosage: Take 3 Tablets Qam And 2 Tablets Bid Po). The following drugs were being taken at the same time:
  • Mycophenolate
When using Tacrolimus, the patient experienced the following unwanted symptoms/side effects: Clostridium Difficile Infection, Guillain-barre SyndromeThe 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 Clostridium Difficile Infection, may become evident only after a product is in use by the general population.
Tacrolimus Side Effect Report#9913412
Pancytopenia, Neutropenic Sepsis, Cytomegalovirus Infection, Leukopenia, Gastrointestinal Disorder, Testicular Germ Cell Cancer Metastatic, Bone Marrow Failure, Enterococcal Infection, Decubitus Ulcer
This Pancytopenia side effect was reported by a consumer or non-health professional from IE. A 42-year-old male patient (weight:NA) experienced the following symptoms/conditions: renal transplant.The patient was prescribed Tacrolimus Systemic (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Prednisolone (Unk)
  • Mycophenolate (Unk)
  • Azathioprine (Unk)
  • Etoposide (80 Mg/m2, Other)
  • Cisplatin (20 Mg/m2, Other)
.After starting to take Tacrolimus Systemic the consumer reported adverse symptoms, such as: Pancytopenia, Neutropenic Sepsis, Cytomegalovirus Infection, Leukopenia, Gastrointestinal Disorder, Testicular Germ Cell Cancer Metastatic, Bone Marrow Failure, Enterococcal Infection, Decubitus UlcerThese side effects may potentially be related to Tacrolimus Systemic. The patient was hospitalized.
Tacrolimus Side Effect Report#9911631
Food Allergy, Blood Immunoglobulin E Increased, Pruritus, Eczema, Infection
This is a report of a 8-year-old female patient (weight: NA) from ZA, suffering from the following health symptoms/conditions: immunosuppression, who was treated with Tacrolimus (dosage: Unk, start time: NS), combined with:
  • Prednisone
and developed a serious reaction and side effect(s): Food Allergy, Blood Immunoglobulin E Increased, Pruritus, Eczema, Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tacrolimus treatment in female patients, resulting in Food Allergy side effect.
Tacrolimus Side Effect Report#9908881
Polymyositis
This report suggests a potential Tacrolimus Polymyositis side effect(s) that can have serious consequences. A 13-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: polymyositis and used Tacrolimus (dosage: NA) starting NS. After starting Tacrolimus the patient began experiencing various side effects, including: PolymyositisAdditional drugs used concurrently:
  • Prednisolone
  • Ciclosporin
  • Methotrexate
  • Mizoribine
Although Tacrolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Polymyositis, may still occur.
Tacrolimus Side Effect Report#9908858
Polyarthritis
This Polyarthritis problem was reported by a physician from AU. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal transplant,immunosuppression. On NS this consumer started treatment with Tacrolimus (dosage: 0.075 Mg/kg, Bid). The following drugs were being taken at the same time:
  • Basiliximab
  • Basiliximab
  • Prednisolone
  • Methylprednisolone
  • Methylprednisolone
  • Methylprednisolone
  • Prednisolone
  • Prednisolone
When using Tacrolimus, the patient experienced the following unwanted symptoms/side effects: PolyarthritisThe 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 Polyarthritis, may become evident only after a product is in use by the general population.
Tacrolimus Side Effect Report#9908852
This Sudden Death side effect was reported by a physician from TR. A 22-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tacrolimus Mr4 Capsules (drug dosage: 3 Mg, Uid/qd), which was initiated on
Sep 04, 2013. Concurrently used drugs: NA..After starting to take Tacrolimus Mr4 Capsules the consumer reported adverse symptoms, such as: These side effects may potentially be related to Tacrolimus Mr4 Capsules.
Tacrolimus Side Effect Report#9904783
Chronic Allograft Nephropathy, Renal Arteriosclerosis, Transplant Rejection, Weight Decreased, Dizziness, Treatment Noncompliance
This is a report of a 31-year-old male patient (weight: NA) from TR, suffering from the following health symptoms/conditions: renal transplant, who was treated with Tacrolimus Mr4 Capsules (dosage: NA, start time:
Jul 26, 2012), combined with:
  • Prednisolon /00016201/ (Unk)
  • Rapamycin (Unk)
and developed a serious reaction and side effect(s): Chronic Allograft Nephropathy, Renal Arteriosclerosis, Transplant Rejection, Weight Decreased, Dizziness, Treatment Noncompliance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tacrolimus Mr4 Capsules treatment in male patients, resulting in Chronic Allograft Nephropathy side effect.


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The appearance of Tacrolimus 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 Tacrolimus Side Effects for Women?

Women Side EffectsReports
Off Label Use 84
Diarrhoea 59
Blood Creatinine Increased 56
Condition Aggravated 54
Pyrexia 50
Pneumonia 49
Death 47
Abdominal Pain 45
Vomiting 44
Anaemia 42

What are common Tacrolimus Side Effects for Men?

Men Side EffectsReports
Death 111
Blood Creatinine Increased 83
Pyrexia 72
Renal Impairment 71
Off Label Use 69
Diarrhoea 64
Pneumonia 62
Cytomegalovirus Infection 54
Renal Failure Acute 51
Condition Aggravated 49

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Why Your Notes are Important

Your notes could be helpful in several ways:

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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.

    Tacrolimus 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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    How Effective is Tacrolimus for You?

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    Tacrolimus Safety Alerts, Active Ingredients, Usage Information

    NDC0168-0416
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTacrolimus
    Nametacrolimus
    Dosage FormOINTMENT
    RouteTOPICAL
    On market since20140909
    LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
    Active Ingredient(s)TACROLIMUS
    Strength(s)1
    Unit(s)mg/g
    Pharma ClassCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]

    More About Tacrolimus

    Side Effects reported to FDA: 3328

    Tacrolimus safety alerts: 2006 2005

    Reported deaths: 678

    Reported hospitalizations: 1207

    Protopic Ointment (tacrolimus)

    Elidel Cream (pimecrolimus)
    Protopic Ointment (tacrolimus)

    Audience: Dermatological and other healthcare professionals
    [Posted 01/20/2006] The Food and Drug Administration announced the approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.
    [January 19, 2006 ?? Protopic Information Page ?? FDA]
    [January 27, 2006 ?? Elidel letter ?? FDA]
    [January 19, 2006 ?? Protopic Letter ?? FDA]

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