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Stelara (Ustekinumab) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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 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 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 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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