Prescription medicine
Reslizumab Brand names: Cinqair
Reslizumab (Cinqair) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the reslizumab FDA label on DailyMed (effective February 29, 2020, Teva Respiratory, LLC); the BLA 761033 record on Drugs@FDA; every reslizumab label on DailyMed.
Highlights of the record
FDA label of February 29, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )]. Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 )]. WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis occurred with CINQAIR infusion in 0.3% of patients in placebo-controlled studies ( 5.1 ) Patients should be observed for an appropriate period of time after CINQAIR infusion; healthcare professionals should be prepared to manage anaphylaxis that can be life-threatening ( 5.1 ) Discontinue CINQAIR immediately if the patient experiences anaphylaxis
Used for
From the label: indications and usageCINQAIR ® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies ( 14 )].
Forms and strengths
- 10 mg/ml
Injection (solution) (concentrate).
On the market
- Earliest approval on file
- March 23, 2016 Cinqair, Teva Respiratory Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 683 through July 30, 2026
What is reslizumab used for?
From the label: indications and usageCINQAIR ® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies ( 14 )]. Limitation of Use: CINQAIR is not indicated for treatment of other eosinophilic conditions. CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )]. CINQAIR is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype ( 1 ). […]
Conditions named in the indications of reslizumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Interleukin-5 Antagonist.
Source: FDA drug label (CINQAIR), Teva Respiratory, LLC, effective February 29, 2020 (SPL set 053b9158-2a5b-48b9-bf47-5fa78a35ec33), via openFDA; the full label on DailyMed
What does the patient leaflet for reslizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about CINQAIR?CINQAIR can cause serious side effects, including: Serious allergic reactions (anaphylaxis). Serious allergic reactions can happen right after you receive your CINQAIR infusion. These reactions can cause death. Allergic reactions sometimes do not happen right away. Your healthcare provider will watch you during and after you receive your CINQAIR infusion for any signs of a reaction. Tell your healthcare provider right away if you have any of the following symptoms that may be associated with an allergic reaction: • breathing problems • flushing • itching • symptoms of low blood pressure (fainting, dizziness, light headedness, confusion, fast heart beat) • paleness • skin rash (hives) • swelling of your face, lips, mouth, or tongue • nausea or abdominal discomfort
Source: FDA drug label (CINQAIR), Teva Respiratory, LLC, effective February 29, 2020 (SPL set 053b9158-2a5b-48b9-bf47-5fa78a35ec33), via openFDA; the full label on DailyMed
Is there a generic for reslizumab (Cinqair)?
No generic reslizumab is approved (Drugs@FDA, October 8, 2026).
- 2016 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for reslizumab?
The FDA Adverse Event Reporting System holds 683 reports that list reslizumab among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as reslizumab?
1 other medicine is given the same way (intravenous) and in the same FDA class as reslizumab or labeled mainly for the same use (asthma), the same class first. Asthma lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Aminophylline | Asthma | 5 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other interleukin-5 antagonists
- the pharmacologic class, with prices and generics
- Reslizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other