What the label lists and what reports show
Reslizumab side effects
Reslizumab's FDA label: “The most common adverse reaction (incidence greater than or equal to 2%) includes oropharyngeal pain.” FAERS holds 683 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 (96 reports).
- No generic listed
- Boxed warning
Check it at the source: the reslizumab FDA label on DailyMed (effective February 29, 2020, Teva Respiratory, LLC); 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 CINQAIR?CINQAIR may cause serious side effects, including: See “What is the most important information I should know about CINQAIR?” abnormal growth of cells or tissue in your body that may or may not be cancer (malignancy) The most common side effects of CINQAIR include throat pain. These are not all the possible side effects of CINQAIR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Teva Respiratory, LLC, effective February 29, 2020 (SPL set 053b9158-2a5b-48b9-bf47-5fa78a35ec33), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction (incidence greater than or equal to 2%) includes oropharyngeal pain.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in other sections of the labeling: Anaphylaxis [see Warnings and Precautions ( 5.1 )] Malignancy [see Warnings and Precautions ( 5.3 )] The most common adverse reaction (incidence greater than or equal to 2%) includes oropharyngeal pain. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 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 clinical practice. Overall, 2195 subjects received at least 1 dose of CINQAIR. The data described below reflect exposure to CINQAIR in 1611 patients with asthma, including 1120 exposed for up to 16 weeks, 1006 exposed for 6 months, 759 exposed for 1 year, and 249 exposed for longer than 2 years. The above referenced safety exposure for CINQAIR is derived from placebo-controlled studies ranging from 15 to 52 weeks in duration (CINQAIR 0.3 mg/kg and 3 mg/kg [n=1131] and placebo [n=730]) and 480 new CINQAIR 3 mg/kg exposures (previously on placebo) from a single open-label extension study (n=1051). …
Source: FDA drug label, Teva Respiratory, LLC, effective February 29, 2020 (SPL set 053b9158-2a5b-48b9-bf47-5fa78a35ec33), via openFDA; the full label on DailyMed
What do FAERS reports show?
683 reports list reslizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 17 are coded as a death and 142 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. Of the 21 reactions below, 8 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?
- Reslizumab: 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