Index of reports
> Cases with Off Label Use (41)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Stelara (Ustekinumab) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 41 Next >>
Possible Stelara side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Off Label Use, Therapeutic Response Unexpected, Scleroderma
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in male
Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-24
Patient: male
Reactions: Off Label Use, Hyperaesthesia, Pain in Extremity, Paraesthesia
Drug(s) suspected as cause:
Stelara
Indication: Arthritis
Start date: 2012-04-17
End date: 2012-05-15
Stelara
Indication: Psoriasis
Start date: 2012-04-17
End date: 2012-05-15
Other drugs received by patient: Omacor; Lercanidipine; Aspirin and Dipyridamole; Arcoxia; Spiriva; Lipitor; Isoniazid; NU-Seals; Perindopril Erbumine
Possible Stelara side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Off Label Use, Anal Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Stelara
Dosage: 1st injection
Start date: 2011-10-05
Stelara
Dosage: 2nd injection
Start date: 2011-11-09
Stelara
Dosage: 2nd injection
Indication: Psoriasis
Start date: 2011-11-09
Stelara
Dosage: 1st injection
Indication: Nail Psoriasis
Start date: 2011-10-05
Other drugs received by patient: Atorvastatin; Micardis
Possible Stelara side effects in female
Reported by a physician from United States on 2012-08-03
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Off Label Use, Colon Cancer Metastatic, Therapeutic Response Unexpected
Adverse event resulted in: death
Drug(s) suspected as cause:
Humira
Dosage: 17 injections
Indication: Pyoderma Gangrenosum
Start date: 2011-03-01
End date: 2011-10-01
Stelara
Dosage: 2nd injection
Indication: Pyoderma Gangrenosum
Start date: 2012-03-05
End date: 2012-03-05
Stelara
Dosage: 1st injection
Start date: 2011-11-03
End date: 2011-11-03
Other drugs received by patient: Remicade; Clindamycin
Possible Stelara side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: male, weighing 119.8 kg (263.5 pounds)
Reactions: Off Label Use, Glycosylated Haemoglobin Increased, Self-Medication, Blood Glucose Increased
Drug(s) suspected as cause:
Stelara
Start date: 2012-06-08
End date: 2012-06-08
Stelara
Dosage: dose was corrected to 90 mg
Indication: Psoriasis
Start date: 2012-06-08
Stelara
Dosage: dose was corrected to 90 mg
Indication: Psoriatic Arthropathy
Start date: 2012-06-08
Stelara
Start date: 2012-06-08
End date: 2012-06-08
Other drugs received by patient: Metformin Hydrochloride; Amitriptyline Hydrochloride; Methotrexate; Cyclobenazprine; Tramadol Hydrochloride
Possible Stelara side effects in male
Reported by a physician from United States on 2012-07-23
Patient: male, weighing 133.8 kg (294.4 pounds)
Reactions: Off Label Use, Vision Blurred, Transient Global Amnesia, Transient Ischaemic Attack
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Albuterol
Indication: Asthma
Start date: 2012-02-20
End date: 2012-03-10
Advair Diskus 100 / 50
Indication: Asthma
Start date: 2012-02-20
End date: 2012-03-10
Levaquin
Administration route: Oral
Indication: Malaise
Start date: 2012-03-03
End date: 2012-03-10
Stelara
Indication: Hidradenitis
Start date: 2012-03-23
Stelara
Start date: 2012-04-23
Prednisone
Administration route: Oral
Indication: Malaise
Start date: 2012-03-01
End date: 2012-03-10
Possible Stelara side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-20
Patient: 60 year old female
Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Multiple Sclerosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Stelara
Start date: 2010-01-01
Stelara
Indication: Crohn's Disease
Start date: 2011-09-01
Other drugs received by patient: Duragesic-100; Corticosteroids; Spasfon; Debridat
Possible Stelara side effects in female
Reported by a physician from United States on 2012-07-17
Patient: female, weighing 53.1 kg (116.8 pounds)
Reactions: Off Label Use, Colon Cancer Metastatic
Adverse event resulted in: death
Drug(s) suspected as cause:
Stelara
Dosage: 2nd injection
Start date: 2012-03-05
End date: 2012-03-05
Stelara
Dosage: 1st injection
Indication: Pyoderma Gangrenosum
Start date: 2011-11-03
End date: 2011-11-03
Humira
Dosage: 17 injections
Indication: Pyoderma Gangrenosum
Start date: 2011-03-01
End date: 2011-10-01
Other drugs received by patient: Remicade
Possible Stelara side effects in female
Reported by a physician from United States on 2012-07-12
Patient: female, weighing 53.1 kg (116.8 pounds)
Reactions: Off Label Use, Colon Cancer Metastatic
Adverse event resulted in: death
Drug(s) suspected as cause:
Stelara
Dosage: 1st injection
Start date: 2011-11-01
End date: 2011-11-01
Stelara
Dosage: 2nd injection
Indication: Pyoderma Gangrenosum
Start date: 2012-03-01
End date: 2012-03-01
Possible Stelara side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: male, weighing 72.6 kg (159.7 pounds)
Reactions: Confusional State, Off Label Use, Cerebral Atrophy, Abnormal Loss of Weight, Headache
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in 61 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05
Patient: 61 year old male
Reactions: Off Label Use, Psoriasis, Blood Glucose Increased
Drug(s) suspected as cause:
Stelara
Dosage: initial, then at 4 weeks after that every 12 weeks. decreased dosing of ustekinumab to every 8 weeks
Indication: Psoriasis
Start date: 2012-02-18
Stelara
Dosage: initial, then at 4 weeks after that every 12 weeks. decreased dosing of ustekinumab to every 8 weeks
Indication: Psoriatic Arthropathy
Start date: 2012-02-18
Other drugs received by patient: Losartan Potassium; Aspirin; Metformin HCL
Possible Stelara side effects in male
Reported by a physician from Spain on 2012-06-18
Patient: male, weighing 104.0 kg (228.8 pounds)
Reactions: Off Label Use, Pulmonary Embolism
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Stelara
Start date: 2012-03-01
End date: 2012-04-04
Stelara
Indication: Pyoderma Gangrenosum
Start date: 2012-04-04
End date: 2012-04-04
Stelara
Indication: Hidradenitis
Start date: 2012-04-04
End date: 2012-04-04
Stelara
Start date: 2012-03-01
End date: 2012-04-04
Other drugs received by patient: Rabeprazole Sodium; Calcium; Sintrom; Prednisone
Possible Stelara side effects in male
Reported by a physician from France on 2012-06-11
Patient: male
Reactions: Off Label Use, Anal Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Stelara
Dosage: 2nd injection
Indication: Nail Psoriasis
Start date: 2011-11-09
Stelara
Dosage: 1st injection
Start date: 2011-10-05
Possible Stelara side effects in 41 year old male
Reported by a physician from Portugal on 2012-06-07
Patient: 41 year old male
Reactions: Off Label Use, Hypercholesterolaemia, Neutropenia, Hypertriglyceridaemia
Drug(s) suspected as cause:
Stelara
Other drugs received by patient: Catalip
Possible Stelara side effects in male
Reported by a physician from Spain on 2012-06-04
Patient: male, weighing 104.0 kg (228.8 pounds)
Reactions: Off Label Use, Pulmonary Embolism
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Stelara
Start date: 2012-03-01
End date: 2012-04-04
Stelara
Indication: Hidradenitis
Start date: 2012-04-04
End date: 2012-04-04
Stelara
Start date: 2012-03-01
End date: 2012-04-04
Stelara
Indication: Pyoderma Gangrenosum
Start date: 2012-04-04
End date: 2012-04-04
Other drugs received by patient: Sintrom; Calcium; Rabeprazole Sodium; Prednisone
Possible Stelara side effects in 67 year old male
Reported by a physician from Spain on 2012-05-29
Patient: 67 year old male, weighing 104.0 kg (228.8 pounds)
Reactions: Off Label Use, Embolism
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Stelara
Indication: Pyoderma
Start date: 2012-03-01
End date: 2012-04-01
Stelara
Start date: 2012-04-01
Other drugs received by patient: Prednisone; Omeprazole; Calcium; Sintrom
Possible Stelara side effects in male
Reported by a physician from United States on 2012-05-18
Patient: male, weighing 133.8 kg (294.4 pounds)
Reactions: Off Label Use, Transient Global Amnesia, Transient Ischaemic Attack
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Albuterol
Indication: Asthma
Start date: 2012-02-20
End date: 2012-03-10
Prednisone
Administration route: Oral
Indication: Malaise
Start date: 2012-03-01
End date: 2012-03-10
Advair Diskus 100 / 50
Indication: Asthma
Start date: 2012-02-20
End date: 2012-03-10
Stelara
Indication: Hidradenitis
Start date: 2012-03-01
Levaquin
Administration route: Oral
Indication: Malaise
Start date: 2012-03-03
End date: 2012-03-10
Possible Stelara side effects in
Reported by a physician from United States on 2012-05-11
Patient:
Reactions: Off Label Use, Colon Cancer Metastatic
Drug(s) suspected as cause:
Stelara
Indication: Pyoderma Gangrenosum
Stelara
Stelara
Possible Stelara side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18
Patient: female
Reactions: Off Label Use, Confusional State, Vision Blurred
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in female
Reported by a physician from United States on 2012-04-16
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Off Label Use, Posterior Reversible Encephalopathy Syndrome, Headache
Drug(s) suspected as cause:
Stelara
Indication: Pustular Psoriasis
Start date: 2010-04-06
Stelara
Indication: Psoriatic Arthropathy
Start date: 2010-04-06
Stelara
Start date: 2012-01-24
Stelara
Start date: 2012-01-24
Other drugs received by patient: ALL Other Therapeutic Products; Triamterene and Hydrochlorothiazide; Restasis; Meloxicam
Possible Stelara side effects in male
Reported by a physician from Portugal on 2012-04-11
Patient: male
Reactions: Off Label Use, Therapeutic Response Unexpected, Transaminases Increased
Drug(s) suspected as cause:
Stelara
Stelara
Stelara
Stelara
Stelara
Dosage: 2 months ago
Stelara
Indication: Psoriatic Arthropathy
Stelara
Stelara
Dosage: 2 months ago
Indication: Psoriasis
Other drugs received by patient: Corticosteroids; Methotrexate
Possible Stelara side effects in 23 year old male
Reported by a physician from United States on 2012-04-10
Patient: 23 year old male
Reactions: Off Label Use, Dysarthria, Gait Disturbance, Headache
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-10
Patient: female
Reactions: Dysarthria, Off Label Use, Sensory Disturbance, Vision Blurred
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: male, weighing 83.9 kg (184.6 pounds)
Reactions: Off Label Use, Vomiting, Crohn's Disease, Eating Disorder
Drug(s) suspected as cause:
Stelara
Other drugs received by patient: Paxil; Lamictal
Possible Stelara side effects in female
Reported by a physician from Germany on 2012-03-19
Patient: female
Reactions: Off Label Use, Therapeutic Response Unexpected, Malignant Melanoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Stelara
Indication: Crohn's Disease
Start date: 2010-04-01
Humira
Indication: Crohn's Disease
Possible Stelara side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-19
Patient: female
Reactions: Off Label Use, Drug Ineffective FOR Unapproved Indication, Arthritis
Drug(s) suspected as cause:
Stelara
Indication: Arthritis
Start date: 2011-09-02
Stelara
Start date: 2011-12-23
Possible Stelara side effects in female
Reported by a physician from Spain on 2012-03-06
Patient: female, weighing 55.0 kg (121.0 pounds)
Reactions: Off Label Use, Psoriasis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Stelara
Indication: Psoriatic Arthropathy
Start date: 2009-09-01
End date: 2009-10-01
Stelara
Start date: 2011-10-17
Possible Stelara side effects in 23 year old male
Reported by a pharmacist from Spain on 2012-02-29
Patient: 23 year old male
Reactions: Off Label Use, Herpes Ophthalmic
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in 23 year old male
Reported by a physician from Spain on 2012-02-13
Patient: 23 year old male
Reactions: Off Label Use, Herpes Ophthalmic
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in female
Reported by a physician from Spain on 2012-02-10
Patient: female, weighing 80.0 kg (176.0 pounds)
Reactions: Off Label Use, Pancreatic Carcinoma Metastatic, Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Stelara
Other drugs received by patient: Omeprazole; Amitriptyline HCL; Sitagliptin
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