What the label lists and what reports show
Trandolapril side effects
Trandolapril's FDA label lists its adverse reactions in its own words. FAERS holds 2,026 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 (142 reports).
- Generic listed
- Boxed warning
Check it at the source: the trandolapril FDA label on DailyMed (effective October 31, 2025, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe safety experience in U.S. placebo-controlled trials included 1069 hypertensive patients, of whom 832 received trandolapril tablets. Nearly 200 hypertensive patients received trandolapril tablets for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on trandolapril tablets. Adverse events considered at least possibly related to treatment occurring in 1% of trandolapril tablets-treated patients and more common on trandolapril tablets than placebo, pooled for all doses, are shown below, together with the frequency of discontinuation of treatment because of these events. …
Percentage of Patients with Adverse Events Greater Than Placebo
| Adverse Event | Placebo - Controlled ( TRACE ) Mortality Study Trandolapril N = 876 | Placebo N = 873 |
|---|---|---|
| Cough | 35 | 22 |
| Dizziness | 23 | 17 |
| Hypotension | 11 | 6.8 |
| Elevated serum uric acid | 15 | 13 |
| Elevated BUN | 9.0 | 7.6 |
| PICA or CABG | 7.3 | 6.1 |
| Dyspepsia | 6.4 | 6.0 |
| Syncope | 5.9 | 3.3 |
| Hyperkalemia | 5.3 | 2.8 |
| Bradycardia | 4.7 | 4.4 |
| Hypocalcemia | 4.7 | 3.9 |
| Myalgia | 4.7 | 3.1 |
| Elevated creatinine | 4.7 | 2.4 |
| Gastritis | 4.2 | 3.6 |
| Cardiogenic shock | 3.8 | < 2 |
| Intermittent claudication | 3.8 | < 2 |
| Stroke | 3.3 | 3.2 |
| Asthenia | 3.3 | 2.6 |
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.
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective October 31, 2025 (SPL set 8143a6cf-dadc-4ef7-a8db-d16d7150ad34), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,026 reports list trandolapril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 195 are coded as a death and 1,008 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, 11 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?
- Trandolapril: 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