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 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 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 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 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 male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male
Reactions: Pruritus Generalised, Psoriasis, Depressed Mood, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Stelara
Other drugs received by patient: Diabetes Medication; ALL Other Therapeutics; Aspirin
Possible Stelara side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male, weighing 69.8 kg (153.7 pounds)
Reactions: Blindness Unilateral, Optic Ischaemic Neuropathy
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient:
Reactions: Drug Dose Omission, Staphylococcal Infection
Drug(s) suspected as cause:
Stelara
Possible Stelara side effects in male
Reported by a consumer/non-health professional from Australia on 2012-08-23
Patient: male
Reactions: Lower Respiratory Tract Infection, Influenza
Drug(s) suspected as cause:
Stelara
Indication: Psoriasis
Start date: 2012-05-14
Stelara
Start date: 2012-08-17
Stelara
Start date: 2012-02-27
Stelara
Start date: 2011-10-31
Stelara
Start date: 2011-11-27
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