Prescription medicine
Terlipressin Brand names: Terlivaz
Terlipressin (Terlivaz) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the terlipressin FDA label on DailyMed (effective June 19, 2026, Mallinckrodt Hospital Products Inc.); the NDA 22231 record on Drugs@FDA; every terlipressin label on DailyMed.
Highlights of the record
FDA label of June 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS OR FATAL RESPIRATORY FAILURE.
TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk [see References (15) ]. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% [see Dosage and Administration (2.1), Contraindications (4), and Warnings and Precautions (5.1) ]. WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with ACLF Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO 2 ) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO 2 <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO 2 decreases below 90% ( 2.1 , 4 , 5.1 ).
Used for
From the label: indications and usageTERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
Forms and strengths
- 0.85 mg/5ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- September 14, 2022 Terlivaz, Mallinckrodt Ireland; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- Last listed patent
- April 5, 2037 Terlivaz injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2024 0 Class I among all firms' recalls; latest February 6, 2024
- FAERS reports
- 313 through July 30, 2026
What is terlipressin used for?
From the label: indications and usageTERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit. TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. ( 1 ) Limitation of Use Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.
FDA pharmacologic class: Vasopressin Receptor Agonist.
Source: FDA drug label (Terlivaz), Mallinckrodt Hospital Products Inc., effective June 19, 2026 (SPL set 3a35b86c-f451-4fac-8499-43019e4da354), via openFDA; the full label on DailyMed
Is there a generic for terlipressin (Terlivaz)?
No generic terlipressin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Terlivaz injection, the last expiring on April 5, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has terlipressin been recalled?
The FDA's Enforcement Report lists 1 recall naming terlipressin since 2024: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 6, 2024 | Class II | Mallinckrodt Hospital Products Inc. | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for terlipressin?
The FDA Adverse Event Reporting System holds 313 reports that list terlipressin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 93 are coded as a death and 139 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Terlipressin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other