Does Stelara List Pneumonia as a Side Effect?
Yes, Stelara (ustekinumab) can cause pneumonia. The drug's prescribing information identifies serious infections, including pneumonia, as a known risk. This stems from its mechanism suppressing parts of the immune system (IL-12 and IL-23 pathways), increasing susceptibility to bacterial, viral, fungal, and other infections.[1][2]
How Common Is Pneumonia with Stelara?
Pneumonia occurs infrequently but warrants monitoring. Clinical trials reported infections in 20-37% of patients, with upper respiratory infections most common; pneumonia specifically appeared in post-marketing data and real-world use. In psoriasis trials, serious infections affected 2-3% of patients, including cases of pneumonia. Rates rise with risk factors like age over 65, diabetes, or concurrent immunosuppressants.[1][3]
What Do Patients Report About Pneumonia on Stelara?
User reviews on platforms like Drugs.com note pneumonia in some cases, often linked to long-term use. For example, patients with psoriasis or Crohn's disease describe sudden onset after months or years, sometimes requiring hospitalization. FDA adverse event reports (via FAERS) include over 1,000 pneumonia cases associated with Stelara as of 2023, though causality isn't always confirmed.[4]
Who Is at Higher Risk for Pneumonia on Stelara?
Risk increases for those with:
- Pre-existing lung conditions (e.g., COPD, history of pneumonia).
- Smoking history or exposure.
- Low white blood cell counts or other immune issues.
- Use with drugs like methotrexate or corticosteroids.
Doctors screen via TB tests and chest X-rays before starting, and advise against use in active infections.[1][2]
What Should You Do If Pneumonia Develops on Stelara?
Stop Stelara immediately and seek medical care for symptoms like fever, cough, shortness of breath, or chest pain. Treatment often involves antibiotics or hospitalization. Recovery is possible, but repeat infections have occurred upon rechallenge in some reports. Regular monitoring includes blood tests and infection vigilance.[1]
How Does Stelara's Pneumonia Risk Compare to Similar Drugs?
| Drug | Pneumonia Risk Profile |
|------|------------------------|
| Stelara (ustekinumab) | Moderate; 1-3% serious infections in trials[1] |
| Humira (adalimumab) | Higher; up to 5% serious infections[5] |
| Cosentyx (secukinumab) | Similar; IL-17 inhibitor with comparable infection rates[6] |
| Skyrizi (risankizumab) | Lower reported pneumonia, but similar class warnings[7] |
Stelara's risk is on par with other biologics for psoriasis or IBD, but lower than broad TNF inhibitors like Humira.
Sources
[1]: Stelara Prescribing Information (FDA)
[2]: Drugs.com - Stelara Side Effects
[3]: ClinicalTrials.gov - Ustekinumab Trials
[4]: FDA FAERS Database
[5]: Humira Prescribing Information
[6]: Cosentyx Prescribing Information
[7]: Skyrizi Prescribing Information