DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Protopic (Tacrolimus Topical) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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 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 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 2012-03-23

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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017