Tezspire Side Effects
Tezspire (tezepelumab) is generally well-tolerated with the most common side effects being sore throat (pharyngitis), joint pain (arthralgia), and back pain, while serious allergic reactions including anaphylaxis can occur but are uncommon.
Common Side Effects
The most frequently reported adverse events with Tezspire include 1:
- Sore throat (pharyngitis) - most common adverse effect
- Joint pain (arthralgia) - frequently reported
- Back pain - commonly occurs
- Upper respiratory tract infections 2
- Headache 2
These common side effects are typically mild and do not require treatment discontinuation in most patients 1.
Serious Adverse Events
Allergic (Hypersensitivity) Reactions
The most clinically significant risk is hypersensitivity reactions, including anaphylaxis 1:
- Can occur within hours of administration but may have delayed onset (days after injection) 1
- Symptoms include: rash, hives, swelling of face/mouth/tongue, breathing problems, red/itchy/swollen eyes, fainting, dizziness, or lightheadedness 1
- Patients should be instructed to seek immediate medical care if these symptoms develop 1
- Allergic conjunctivitis has been reported 1
Additional Serious Considerations
Recent pharmacovigilance data identified additional adverse events not prominently featured on the original drug label 3:
- Dyspnea (shortness of breath) - significant signal detected in real-world use
- Body temperature changes - reported in post-marketing surveillance
- Tongue pruritus - identified in safety databases
- Median time to onset of adverse events is approximately 35 days 3
Safety Profile Across Clinical Trials
Large-scale clinical trial data demonstrate favorable safety 4, 5, 6:
- In the PATHWAY and NAVIGATOR trials involving 1,334 patients, the incidence of adverse events was similar between tezepelumab and placebo groups 5
- No increased risk of serious infections, malignancies, or other major safety concerns compared to placebo 6
- Frequencies and types of adverse events did not differ meaningfully between treatment and placebo groups 6
Sex-Specific Differences
Real-world data analysis revealed differences in adverse event patterns between sexes 3:
- Most frequent adverse events in both sexes: arthralgia and dyspnea
- Signal strength ranking differs between males and females, suggesting potential sex-based variations in tolerability 3
Clinical Monitoring Recommendations
Based on FDA labeling, patients should be monitored for 1:
- Signs of hypersensitivity reactions during and after each injection
- Worsening asthma symptoms or lack of improvement after treatment initiation
- Any delayed allergic reactions occurring days after administration
Importantly, Tezspire does not treat acute asthma symptoms or acute exacerbations - patients must be counseled that this is maintenance therapy only 1.