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),
Maternal Exposure During Pregnancy (5),
Mycosis Fungoides (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 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 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 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 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 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 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 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 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 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 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
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