Index of reports
> Cases with Off Label Use (26)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Protopic (Tacrolimus Topical) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 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 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 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 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 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 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 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
Possible Protopic side effects in 80 year old female
Reported by a physician from Germany on 2012-03-28
Patient: 80 year old female
Reactions: Off Label Use, Vulval Cancer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Protopic
Possible Protopic side effects in 80 year old female
Reported by a physician from Germany on 2012-03-23
Patient: 80 year old female
Reactions: Off Label Use, Vulval Cancer
Drug(s) suspected as cause:
Protopic
Dosage: unk
Administration route: Topical
Start date: 2011-02-01
End date: 2011-11-01
Protopic
Dosage: unk
Administration route: Topical
Indication: Lichen Sclerosus
Start date: 2009-02-01
End date: 2010-10-01
Possible Protopic side effects in
Reported by a consumer/non-health professional from United States on 2012-03-09
Patient:
Reactions: Respiratory Disorder, Drug Ineffective FOR Unapproved Indication, Fall, Off Label Use, Weight Increased, Skin Discolouration, Burns Third Degree, Coronary Artery Occlusion, Burn Infection, Application Site Erythema, Eye Disorder, Haematoma, Intervertebral Disc Protrusion, Psoriasis, Condition Aggravated, Application Site Pain, Insomnia, Psoriatic Arthropathy
Drug(s) suspected as cause:
Corticosteroid NOS
Dosage: unk
Indication: Psoriasis
Protopic
Dosage: 0.1 %, unknown/d
Administration route: Topical
Indication: Psoriasis
Protopic
Dosage: 0.03 %, unknown/d
Administration route: Topical
Indication: Burns Second Degree
Start date: 2012-01-27
Possible Protopic side effects in male
Reported by a physician from Germany on 2012-03-05
Patient: male
Reactions: Off Label Use, Dermatitis Atopic, Drug Ineffective
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Protopic
Other drugs received by patient: Fenistil; Octenisept; Unguentum Eumulsificans AQU; Mometasone Furoate; Cefuroxime; Zyrtec
Possible Protopic side effects in male
Reported by a physician from Germany on 2012-02-29
Patient: male, weighing 100.0 kg (220.0 pounds)
Reactions: Off Label Use, Drug Level Increased, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Protopic
Other drugs received by patient: Cortisone Acetate; Myfortic; Methylprednisolone; Gentamicin; Jurnista Bet.m
Possible Protopic side effects in male
Reported by a physician from Germany on 2012-02-27
Patient: male
Reactions: Off Label Use, Renal Failure, Drug Level Increased
Drug(s) suspected as cause:
Protopic
Possible Protopic side effects in male
Reported by a physician from Germany on 2012-02-23
Patient: male
Reactions: Off Label Use, Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Protopic
Possible Protopic side effects in female
Reported by a physician from Japan on 2012-01-20
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: Kindavate; Clindamycin Phosphate; Rinderon-VG
Possible Protopic side effects in 38 year old female
Reported by a physician from France on 2012-01-13
Patient: 38 year old female
Reactions: Transplant Rejection, Thrombotic Microangiopathy, Oral Herpes, Off Label Use, Renal Failure, Gamma-Glutamyltransferase Increased, Hepatotoxicity, Cervix Carcinoma Stage 0, Lipids Abnormal, Hypertension, Renal Failure Acute
Drug(s) suspected as cause:
Protopic
Dosage: /d, topical
Administration route: Topical
Indication: Transplant Rejection
Prograf
Dosage: /d, oral
Administration route: Oral
Indication: Transplant
Start date: 2005-11-27
Other drugs received by patient: Sirolimus (Rapamune); Prednisolone Acetate; Acyclovir; Mycophenolate Mofetil; Clobetasol (Clobetasol); Valacyclovir
Possible Protopic side effects in 67 year old female
Reported by a physician from Japan on 2011-12-29
Patient: 67 year old female
Reactions: Off Label Use, Fungal Skin Infection
Drug(s) suspected as cause:
Protopic
Other drugs received by patient: Rituximab; Prednisolone; Prednisolone; Prednisolone; Rituximab; Cyclosporine
Possible Protopic side effects in 67 year old female
Reported by a physician from Japan on 2011-12-20
Patient: 67 year old female
Reactions: Off Label Use, Fungal Skin Infection
Drug(s) suspected as cause:
Protopic
Other drugs received by patient: Prednisolone; Rituximab; Rituximab; Prednisolone; Prednisolone
Possible Protopic side effects in
Reported by a consumer/non-health professional from United States on 2011-10-19
Patient:
Reactions: Breast Cancer, Off Label Use
Drug(s) suspected as cause:
Protopic
Possible Protopic side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2011-10-14
Patient: female
Reactions: Off Label Use, Medication Error, International Normalised Ratio Increased, Herpes Zoster
Drug(s) suspected as cause:
Protopic
Other drugs received by patient: Warfarin Sodium
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