Reporting a Stelara Side Effect in the US
Call Janssen at 1-877-227-6978 or submit online via their safety portal at Janssen Safety Reporting (see Adverse Reactions section for contact). For FDA MedWatch, use Form 3500 online at FDA MedWatch or download/print the form and mail/fax it.[1][2]
What Info Do You Need to Report?
Provide patient details (age, weight, sex), Stelara dose/regimen, side effect description (onset, severity, duration), other meds, and medical history. Attach lab results or photos if relevant. Reports are confidential.[1]
Reporting Outside the US
In the EU, use the national authority like MHRA (UK) at Yellow Card or EudraVigilance. In Canada, contact Health Canada at 1-866-234-2345 or Janssen Canada. Check Janssen's global site for your country.[3]
Why Report and What Happens Next?
Reports help track safety signals and update labels. Janssen/FDA review anonymously; you may get a confirmation but no individual follow-up unless specified. Doctors can report on your behalf via VAERS or similar.[2]
Common Stelara Side Effects Patients Report
Upper respiratory infections, headache, injection site reactions, fatigue. Serious ones include infections, malignancy risk, or hypersensitivity—report promptly if severe.[4]
[1] Janssen Stelara Prescribing Information, 2023. Link
[2] FDA MedWatch Program. Link
[3] EMA Pharmacovigilance. Link
[4] Stelara Clinical Safety Data, FDA Label. Link