What the label lists and what reports show
Terlipressin side effects
Terlipressin's FDA label: “The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.” FAERS holds 313 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 ascites (22 reports).
- 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 FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Table 1: Adverse Reactions Reported by ≥4 % of TERLIVAZ-Treated Patients
| Reaction | TERLIVAZ (N=200) | Placebo (N=99) |
|---|---|---|
| Abdominal pain | 39 (19.5) | 6 (6.1) |
| Nausea | 32 (16.0) | 10 (10.1) |
| Respiratory failure | 31 (15.5) | 7 (7.1) |
| Diarrhea | 26 (13.0) | 7 (7.1) |
| Dyspnea | 25 (12.5) | 5 (5.1) |
| Fluid overload | 17 (8.5) | 3 (3.0) |
| Pleural effusion | 11 (5.5) | 0 (0.0) |
| Sepsis | 11 (5.5) | 1 (1.0) |
| Bradycardia | 10 (5.0) | 0 (0.0) |
| Ischemia-related events Ischemia-related events include skin discoloration, cyanosis,… | 9 (4.5) | 0 (0.0) |
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 adverse reactions are discussed elsewhere in the labeling: Serious or Fatal Respiratory Failure [see Warnings and Precautions (5.1) ] Ischemic Events [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 1-800-844-2830 and www.Mallinckrodt.com 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, the adverse reaction rates observed in the clinical trials of TERLIVAZ cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TERLIVAZ was evaluated in the CONFIRM trial [see Clinical Studies (14) ]. The average daily dose of TERLIVAZ was 3.1 mg (range 0.8 to 5.8 mg), with a mean duration of exposure to TERLIVAZ of 6.2 days (range 1 to 15 days). Treatment discontinuation due to adverse events occurred in 12.0% (24/200) of patients receiving TERLIVAZ and 5.1% (5/99) of patients receiving placebo. The most common adverse reactions that led to TERLIVAZ discontinuation were respiratory failure, abdominal pain, and intestinal ischemia/obstruction. …
Source: FDA drug label, Mallinckrodt Hospital Products Inc., effective June 19, 2026 (SPL set 3a35b86c-f451-4fac-8499-43019e4da354), via openFDA; the full label on DailyMed
What do FAERS reports show?
313 reports list terlipressin among the medicines taken, 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. Of the 20 reactions below, 4 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.
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?
- Terlipressin: 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