DrugLib.com — Drug Information Portal

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

Stelara (Ustekinumab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Stelara (Ustekinumab) 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 (1698)
Death (97)
Life Threatening Events (94)
Disability (40)

Reports by Reaction Type

Psoriasis (128)Myocardial Infarction (71)Pneumonia (69)Drug Ineffective (67)Headache (60)Off Label Use (41)Arthralgia (40)Drug Dose Omission (34)Dizziness (34)Psoriatic Arthropathy (34)Depression (33)Cerebrovascular Accident (33)

Below are a few examples of reports where side effects / adverse reactions may be related to Stelara (Ustekinumab). For a complete list or a specific selection of reports, please use the links above.

Possible Stelara side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-27

Patient: female

Reactions: Hysterectomy, Drug Effect Decreased, Skin Lesion

Drug(s) suspected as cause:
Stelara
    Start date: 2012-08-03

Stelara
    Indication: Psoriasis
    Start date: 2012-04-17



Possible Stelara side effects in female

Reported by a physician from Japan on 2012-08-27

Patient: female

Reactions: Arthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Guillain-Barre Syndrome

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Stelara

Other drugs received by patient: Prilosec



Possible Stelara side effects in male

Reported by a physician from South Africa on 2012-08-27

Patient: male

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: female, weighing 83.0 kg (182.6 pounds)

Reactions: Drug Ineffective, Posterior Reversible Encephalopathy Syndrome, Psoriasis, Psoriatic Arthropathy

Drug(s) suspected as cause:
Stelara

Other drugs received by patient: Corticosteroid; Tegretol; Lyrica



Possible Stelara side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female, weighing 79.4 kg (174.6 pounds)

Reactions: Back Pain, Neuropathy Peripheral, Bone Pain

Drug(s) suspected as cause:
Stelara
    Dosage: 2 loading dose injections
    Start date: 2012-01-01

Stelara
    Dosage: 2 loading dose injections
    Indication: Psoriasis
    Start date: 2012-01-01

Other drugs received by patient: Simvastatin; Hydrochlorothiazide; Ambien



Possible Stelara side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-27

Patient: male

Reactions: Pneumonia

Drug(s) suspected as cause:
Stelara
    Start date: 2011-02-01

Stelara
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-23



Possible Stelara side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27

Patient: female

Reactions: Confusional State

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in 59 year old female

Reported by a physician from United States on 2012-08-27

Patient: 59 year old female, weighing 127.0 kg (279.4 pounds)

Reactions: Cardiac Failure

Drug(s) suspected as cause:
Stelara

Other drugs received by patient: Medication FOR Diabetes; Unspecified Lupus Medication



Possible Stelara side effects in 49 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 49 year old male

Reactions: Prostatic Specific Antigen Increased

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Chills, Psoriasis, Scleroderma, Infusion Related Reaction

Drug(s) suspected as cause:
Remicade
    Indication: Psoriatic Arthropathy

Stelara
    Indication: Psoriatic Arthropathy



Possible Stelara side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female, weighing 108.9 kg (239.5 pounds)

Reactions: Drug Dose Omission, Drug Ineffective, Urinary Tract Infection, Gastric Disorder, Pernicious Anaemia, Respiratory Tract Infection, Hypertension, Influenza Like Illness

Drug(s) suspected as cause:
Stelara
    Start date: 2011-08-01
    End date: 2011-01-01

Stelara
    Start date: 2012-07-01

Stelara
    Start date: 2011-08-01
    End date: 2011-01-01

Stelara
    Start date: 2011-01-01
    End date: 2012-02-01

Stelara
    Indication: Psoriatic Arthropathy
    Start date: 2011-01-01
    End date: 2012-02-01

Stelara
    Indication: Psoriasis
    Start date: 2012-07-01

Other drugs received by patient: Insulin



Possible Stelara side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Stelara

Other drugs received by patient: Aspirin; Prasugrel; Lipitor; Perindopril; Pantoprazole



Possible Stelara side effects in 32 year old male

Reported by a physician from United States on 2012-08-27

Patient: 32 year old male, weighing 104.3 kg (229.5 pounds)

Reactions: Splenic Infection, Epstein-Barr Virus Test Positive

Drug(s) suspected as cause:
Celebrex
    Dosage: two weel prior to 20-apr-2012
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-01

Stelara
    Indication: Psoriasis



Possible Stelara side effects in male

Reported by a physician from Canada on 2012-08-27

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in male

Reported by a physician from Japan on 2012-08-27

Patient: male

Reactions: Cardiac Failure, Lung Neoplasm, Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Stelara
    Start date: 2011-02-06

Stelara
    Indication: Psoriasis
    Start date: 2012-01-26



Possible Stelara side effects in male

Reported by a physician from Austria on 2012-08-24

Patient: male, weighing 98.0 kg (215.6 pounds)

Reactions: Lymphopenia, Bronchitis, Leukocytosis, Cough, Infection

Drug(s) suspected as cause:
Stelara
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-03

Stelara
    Start date: 2012-07-05



Possible Stelara side effects in female

Reported by a physician from Canada on 2012-08-24

Patient: female, weighing 83.0 kg (182.6 pounds)

Reactions: Drug Ineffective, Cervical Myelopathy, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in female

Reported by a pharmacist from United Kingdom on 2012-08-24

Patient: female

Reactions: Diarrhoea, Bone Pain, Parosmia, Hyperhidrosis, Decreased Appetite, Influenza

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 60 year old female

Reactions: Urticaria, Osteomyelitis

Drug(s) suspected as cause:
Clindamycin
    Administration route: Oral
    Indication: Osteomyelitis

Clindamycin

Stelara
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01



Possible Stelara side effects in 47 year old male

Reported by a physician from Norway on 2012-08-24

Patient: 47 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Drug Ineffective, Eye Operation

Drug(s) suspected as cause:
Stelara
    Start date: 2011-10-01
    End date: 2012-08-10

Stelara
    Indication: Psoriasis
    Start date: 2010-06-01
    End date: 2010-12-01



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 61 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-24

Patient: 61 year old male, weighing 135.0 kg (297.0 pounds)

Reactions: Renal Failure, Hepatic Neoplasm Malignant, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Psoriasis
    Start date: 2010-08-05
    End date: 2011-11-01

Enbrel
    Dosage: 50 mg, weekly
    Start date: 2012-02-01
    End date: 2012-03-01

Stelara
    Dosage: 90 mg, once every twelve weeks administered once
    Indication: Psoriasis
    Start date: 2011-12-01
    End date: 2012-01-01



Possible Stelara side effects in male

Reported by a physician from Netherlands on 2012-08-24

Patient: male, weighing 81.0 kg (178.2 pounds)

Reactions: Hyperhidrosis, Diffuse Large B-Cell Lymphoma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Stelara

Other drugs received by patient: Ranitidine A; Omeprazol A



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 female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Drug Dose Omission, Latent Tuberculosis

Drug(s) suspected as cause:
Enbrel
    Indication: Psoriasis
    Start date: 2009-09-02
    End date: 2010-03-09

Stelara
    Indication: Psoriasis
    Start date: 2010-04-07
    End date: 2012-02-06

Other drugs received by patient: Dimenhydrinate; ALL Other Therapeutic Agents; Vytorin; Advil; Prednisone TAB; ALL Other Therapeutic Agents



Possible Stelara side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: female

Reactions: Subcutaneous Abscess

Drug(s) suspected as cause:
Stelara
    Start date: 2012-05-25

Stelara
    Indication: Psoriasis
    Start date: 2012-04-28



Possible Stelara side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Macular Fibrosis, Neuritis

Drug(s) suspected as cause:
Stelara



Possible Stelara side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: male

Reactions: Arthralgia, Psoriasis, Antibody Test Positive

Drug(s) suspected as cause:
Stelara
    Start date: 2011-12-09

Stelara
    Start date: 2011-06-28

Stelara
    Start date: 2011-03-01

Stelara
    Start date: 2012-02-29

Stelara
    Start date: 2011-03-29

Stelara
    Indication: Psoriasis
    Start date: 2011-09-20

Stelara
    Start date: 2012-05-17

Stelara
    Start date: 2012-08-14



Possible Stelara side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: female

Reactions: Drug Ineffective, Intraocular Pressure Increased, Psoriasis, Tooth Infection, Disturbance in Attention, Vertigo, Dizziness, Sinusitis, Influenza

Drug(s) suspected as cause:
Stelara
    Start date: 2011-06-19

Stelara
    Start date: 2012-06-06

Stelara
    Start date: 2011-09-12

Stelara
    Start date: 2010-11-20

Stelara
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-12-17

Stelara
    Start date: 2012-02-21

Stelara
    Start date: 2011-03-11

Stelara
    Start date: 2011-11-29

Other drugs received by patient: Micardis; Claritin; Methotrexate; Colgout; Mobic; Nexium

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

All Rights reserved - Copyright DrugLib.com, 2006-2014