What the label lists and what reports show
Tezepelumab side effects
Tezepelumab's FDA label: “Most common adverse reactions (incidence ≥ 3%) are: • Asthma: pharyngitis, arthralgia, and back pain.” FAERS holds 6,290 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (583 reports).
- No generic listed
Check it at the source: the tezepelumab FDA label on DailyMed (effective October 17, 2025); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TEZSPIRE?TEZSPIRE may cause serious side effects, including: • allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your TEZSPIRE injection. Allergic reactions can sometimes happen hours or days after you get a dose of TEZSPIRE. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of allergic reaction: ∘ rash ∘ hives ∘ swelling of your face, mouth, and tongue ∘ breathing problems ∘ red, itchy, swollen, or inflamed eyes ∘ fainting, dizziness, feeling lightheaded The most common side effects of TEZSPIRE include: • sore throat (pharyngitis) • common cold symptoms (nasopharyngitis) • flu • joint pain (arthralgia) • upper respiratory tract infections • injection site reactions • back pain • nose bleeds These are not all of the possible side effects of TEZSPIRE. […]
Source: FDA drug label, Amgen Inc, effective October 17, 2025 (SPL set 60f0aa03-ad25-4d48-80ce-7fcfa76f325f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 3%) are: • Asthma: pharyngitis, arthralgia, and back pain.
Table 2 Adverse Reactions with TEZSPIRE with Incidence Greater than or Equal to 3% and More Common than Placebo in Patients with CRSwNP (WAYPOINT)
| Adverse Reaction | TEZSPIRE N=203 % | Placebo N=205 % |
|---|---|---|
| Nasopharyngitis | 18 | 10 |
| Upper respiratory tract infection Upper respiratory tract infection (including Upper… | 12 | 8 |
| Epistaxis | 6 | 3 |
| Pharyngitis Pharyngitis (including Pharyngitis, Pharyngitis bacterial, Pharyngitis… | 5 | 1 |
| Back pain | 5 | 2 |
| Influenza | 4 | 1 |
| Injection site reaction Injection site reaction (e.g., Injection site erythema, Injection… | 4 | 2 |
| Arthralgia | 3 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 3%) are: • Asthma: pharyngitis, arthralgia, and back pain. ( 6.1 ) • Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Patients 12 Years of Age and Older with Asthma The safety of TEZSPIRE in asthma was based on the pooled safety population from PATHWAY and NAVIGATOR, which consists of 665 adult and pediatric patients 12 years of age and older with severe asthma who received at least one dose of TEZSPIRE 210 mg subcutaneously once every 4 weeks. The two placebo-controlled clinical trials were of 52 weeks duration. …
Source: FDA drug label, Amgen Inc, effective October 17, 2025 (SPL set 60f0aa03-ad25-4d48-80ce-7fcfa76f325f), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,290 reports list tezepelumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 236 are coded as a death and 1,161 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,784, against a median of 7 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tezepelumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions