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Protopic (Tacrolimus Topical) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Protopic (Tacrolimus Topical) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (63)
Death (2)
Life Threatening Events (2)
Disability (4)

Reports by Reaction Type

Off Label Use (26)Mycosis Fungoides (5)Maternal Exposure During Pregnancy (5)Headache (4)Myocardial Infarction (4)Blood Potassium Decreased (4)Drug Ineffective (3)Pain (3)Fall (3)Gastrooesophageal Reflux Disease (3)Dermatitis Atopic (3)B-Cell Lymphoma (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Protopic (Tacrolimus Topical). For a complete list or a specific selection of reports, please use the links above.

Possible Protopic side effects in female

Reported by a physician from Japan on 2012-08-22

Patient: female, weighing 64.8 kg (142.6 pounds)

Reactions: Foetal Distress Syndrome, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in male

Reported by a physician from Poland on 2012-08-20

Patient: male

Reactions: Dermatitis Atopic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Protopic

Other drugs received by patient: Ebastine; Elidel



Possible Protopic side effects in

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient:

Reactions: Overdose, Uterine Leiomyoma, Gastric Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Protopic
    Dosage: 0.03 %, bid
    Administration route: Topical
    Indication: Dermatitis Atopic
    Start date: 2011-04-01

Protopic
    Dosage: 0.1 %, bid
    Administration route: Topical
    Start date: 2011-04-01

Other drugs received by patient: Enbrel; Omeprazole; Singulair; Folic Acid; Hydroxychlor; Methotrexate; Prednisone TAB



Possible Protopic side effects in 44 year old female

Reported by a physician from Japan on 2012-08-17

Patient: 44 year old female

Reactions: Lichen Planus, Drug Ineffective FOR Unapproved Indication

Drug(s) suspected as cause:
Protopic

Other drugs received by patient: Methylprednisolone; Prednisolone; Polygam S / D



Possible Protopic side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-16

Patient: 17 year old female

Reactions: Nightmare, Insomnia, Hyperhidrosis

Drug(s) suspected as cause:
Protopic

Other drugs received by patient: Hydrocortisone



Possible Protopic side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09

Patient: male

Reactions: Laceration, Dysplasia, Hypoaesthesia, Stress, Rhinitis Allergic, Balance Disorder, Serositis, Pasteurella Infection, Dizziness, Fibrosis, non-Hodgkin's Lymphoma, Bone Neoplasm, Injury, Essential Hypertension

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Elidel
    Dosage: df topical
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    Start date: 2003-04-01
    End date: 2006-12-01

Protopic
    Dosage: df
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Clindamycin; Doxycycline; Bupropion HCL; Sertralne; Hydrocodone W / Apap / 01554201 /; Cefadroxil; Chlorhexidine Gluconate; Clarinex / 01202601 /; Methylprednisolone; Lorazepam; Alprazolam; Ibuprofen; Lexapro; Benzonatate; Prochlorperazine; Penicillin VK; Ibuprofen (Advil); Zoloft



Possible Protopic side effects in 7 year old male

Reported by a physician from United States on 2012-07-27

Patient: 7 year old male

Reactions: Lentigo

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in 8 year old female

Reported by a physician from United States on 2012-07-27

Patient: 8 year old female

Reactions: Lentigo

Drug(s) suspected as cause:
Protopic
    Dosage: 0.005%, unknown/d, topical
    Administration route: Topical
    Indication: Ichthyosis

Protopic
    Dosage: 0.005%, unknown/d, topical
    Administration route: Topical
    Indication: Dermatitis Atopic



Possible Protopic side effects in female

Reported by a consumer/non-health professional from Germany on 2012-07-27

Patient: female

Reactions: Off Label Use, Adverse Drug Reaction, Feeling Hot, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in male

Reported by a physician from Poland on 2012-07-19

Patient: male

Reactions: Investigation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in 39 year old female

Reported by a physician from Japan on 2012-07-16

Patient: 39 year old female

Reactions: Lymphangioma

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in female

Reported by a physician from France on 2012-07-11

Patient: female

Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Conjunctivitis

Drug(s) suspected as cause:
Protopic
    Dosage: unk
    Administration route: Topical
    Indication: Dermatitis Atopic

Protopic
    Dosage: unk
    Administration route: Topical
    Start date: 2011-01-01

Other drugs received by patient: Nasonex; Singulair



Possible Protopic side effects in 9 year old female

Reported by a physician from Japan on 2012-07-10

Patient: 9 year old female

Reactions: Skin Papilloma, Herpes Simplex, Acne

Drug(s) suspected as cause:
Protopic

Other drugs received by patient: Propeto (White Soft Paraffin); Hirudoid (Mucopolysaccharide Polysulfuric Acid Ester); Nerisone; Locoid; Clindamycin Phosphate; Allegra



Possible Protopic side effects in female

Reported by a physician from France on 2012-07-03

Patient: female

Reactions: Off Label Use, Neoplasm

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in 31 year old female

Reported by a pharmacist from Canada on 2012-06-27

Patient: 31 year old female

Reactions: Sensory Loss, Paralysis

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-06

Patient: female

Reactions: Off Label Use, Wrong Technique in Drug Usage Process, B-Cell Lymphoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in female

Reported by a physician from Japan on 2012-06-06

Patient: female, weighing 72.5 kg (159.5 pounds)

Reactions: Off Label Use, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Protopic

Other drugs received by patient: Betamethasone Sodium Phosphate; Kindavate; Clindamycin Phosphate



Possible Protopic side effects in female

Reported by a consumer/non-health professional from Czech Republic on 2012-06-06

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in male

Reported by a lawyer from United States on 2012-05-24

Patient: male, weighing 78.9 kg (173.6 pounds)

Reactions: Night Sweats, Economic Problem, Lymphadenopathy, Pyrexia, Headache, Oropharyngeal Pain, Upper Respiratory Tract Infection, Palpitations, Thyroiditis, White Blood Cell Count Increased, Anaemia, Laceration, Aspartate Aminotransferase Increased, Jaundice, Pain, Drug Abuse, Fall, Stem Cell Transplant, Road Traffic Accident, Fatigue, Dizziness, Sinusitis, Pilonidal Cyst, Vomiting, Nausea, Alanine Aminotransferase Increased, Musculoskeletal Pain, Febrile Neutropenia, Eosinophilia, Hodgkin's Disease, Anxiety, Syncope, Oral Disorder, Bronchitis

Drug(s) suspected as cause:
Elidel
    Dosage: (bid topical)
    Administration route: Topical
    Indication: Eczema
    Start date: 2005-03-17

Protopic
    Dosage: (df)
    Indication: Eczema

Colace (Not Specified)
    Dosage: (100 mg qd oral)
    Administration route: Oral

Other drugs received by patient: Aranesp; Pramoxine Hydrochloride; Magnesium Sulfate; Sodium Phosphate; Potassium Chloride; Moxifloxacin; Flexeril; Etoposide; Neulasta; Oxycontin; Camphor; Alkeran; Zyrtec; Ambien; Chemotherapeutics; Nexium; Valtrex; Famotidine; Colace; Procarbazine Hydrochloride; Cytoxan; Mesna; Carboplatin W / Etoposide / Ifosfamide; Pepcid; Ibuprofen; Lasix; Advair Diskus 100 / 50; Prednisone; Epinephrine; Sodium Chloride; Sudafed S.a.; Oxycodone Hydrochloride; Klonopin; Kytril; Zantac; Albuterol; Xanax; Acetaminophen; Proair / 00972202 /; Multi-Vitamins; Zofran; Ativan; Senna / 00142201 /; Vicodin; Vincristine; Decadron; Heparin; Mineral OIL Emulsion; Cytosar-U; Adriamycin PFS; Bleomycin Sulfate; Aspirin; Diphenhydramine HCL



Possible Protopic side effects in female

Reported by a physician from France on 2012-05-15

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Off Label Use, Acute Myeloid Leukaemia

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in 17 year old male

Reported by a physician from Japan on 2012-05-14

Patient: 17 year old male

Reactions: Off Label Use, Drug Ineffective, Chronic Graft Versus Host Disease, Pemphigoid

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prograf
    Indication: Acute Graft Versus Host Disease

Protopic
    Dosage: unk
    Administration route: Topical
    Indication: Pemphigoid

Other drugs received by patient: Prednisolone; Methotrexate



Possible Protopic side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-11

Patient: 36 year old female

Reactions: Off Label Use, Scab, Nasal Septum Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Locoid
    Dosage: 1 df, other, topical
    Administration route: Topical
    Indication: Psoriasis
    Start date: 1993-01-01

Protopic
    Dosage: 1 df, other, topical
    Administration route: Topical
    Indication: Psoriasis
    Start date: 2010-01-01



Possible Protopic side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-04

Patient: 32 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Burning Sensation, Pruritus, Condition Aggravated

Drug(s) suspected as cause:
Protopic

Other drugs received by patient: Flucloxacillin



Possible Protopic side effects in male

Reported by a physician from United States on 2012-04-30

Patient: male, weighing 42.0 kg (92.4 pounds)

Reactions: Obsessive-Compulsive Disorder, Tooth Extraction, Orthostatic Hypotension, Oropharyngeal Pain, Headache, Off Label Use, Autism, Burkitt's Lymphoma Stage II, Upper Respiratory Tract Infection, Melanocytic Naevus, Pharyngitis Streptococcal, Tympanic Membrane Perforation, Bronchiolitis, Cerumen Impaction, Urine Output Decreased, Otitis Media Acute, Otitis Externa, Hepatic Steatosis, Embolism Venous, Nasal Abscess, Excessive Granulation Tissue, Wrist Fracture, Tonsillitis, Fall, Constipation, Synovial Cyst, Liver Disorder, Abdominal Pain Upper, Muscle Strain, Fatigue, Pleural Effusion, Depression, Dysgraphia, Gastrooesophageal Reflux Disease, Viral Infection, Small Intestinal Bacterial Overgrowth, Radius Fracture, Abdominal Abscess, Pneumonia Bacterial, Splinter, Bronchitis, Localised Intraabdominal Fluid Collection, Infectious Peritonitis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Protopic
    Dosage: 0.1 %, bid prn
    Administration route: Topical
    Indication: Dermatitis Atopic
    Start date: 2009-01-02

Protopic
    Dosage: 0.1 %, bid prn
    Administration route: Topical
    Indication: Eczema
    Start date: 2004-01-01
    End date: 2005-01-01

Protopic
    Dosage: 0.1 %, bid
    Administration route: Topical

Other drugs received by patient possibly interacting with the suspect drug:
Elidel
    Dosage: 1 %, unknown/d
    Indication: Eczema

Other drugs received by patient: Cutivate; Bactroban; Lidex; Allegra



Possible Protopic side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30

Patient: 46 year old female, weighing 62.1 kg (136.7 pounds)

Reactions: Drug Ineffective, Drug Hypersensitivity, Eye Pain, Eyelid Pain

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-30

Patient: 36 year old female

Reactions: Off Label Use, Nasal Septum Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Locoid
    Dosage: 1 df, other
    Administration route: Topical
    Indication: Psoriasis
    Start date: 1993-01-01

Protopic
    Dosage: 1 df, other
    Administration route: Topical
    Indication: Psoriasis
    Start date: 2010-01-01



Possible Protopic side effects in female

Reported by a physician from France on 2012-04-23

Patient: female

Reactions: Off Label Use, Acute Myeloid Leukaemia

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-03

Patient: 49 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Subcutaneous Abscess, Pain, Scar

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Protopic
    Dosage: topical twice daily topical
    Administration route: Topical
    Indication: DRY Skin
    Start date: 2012-03-06
    End date: 2012-03-09

Protopic
    Dosage: topical twice daily topical
    Administration route: Topical
    Indication: Rosacea
    Start date: 2012-03-06
    End date: 2012-03-09



Possible Protopic side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-02

Patient: female

Reactions: Off Label Use, B-Cell Lymphoma, Medication Error

Drug(s) suspected as cause:
Protopic



Possible Protopic side effects in female

Reported by a consumer/non-health professional from France on 2012-03-28

Patient: female

Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Eye Irritation, Visual Acuity Reduced

Drug(s) suspected as cause:
Protopic
    Dosage: unk
    Administration route: Topical
    Indication: Dermatitis Atopic

Protopic
    Dosage: unk
    Administration route: Topical
    Start date: 2011-01-01

Other drugs received by patient: Singulair; Nasonex

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