Trandolapril
Trandolapril is an ACE inhibitor (a blood pressure–lowering medicine) used to treat high blood pressure and, after a heart attack, to reduce the risk of death and hospitalization in patients with heart failure or reduced heart pumping function.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Trandolapril (Mavik) is an ACE inhibitor, a medicine that relaxes blood vessels, used for high blood pressure and, after a heart attack with weakened pumping, to cut the risk of death and heart failure hospitalization; on the market since the mid-1990s and available as a generic, it is a less familiar relative of lisinopril. Most people tolerate it well, though a dry, nagging cough and early dizziness are what people notice, and blood tests check potassium and kidney function. The boxed warning is about pregnancy, since it can injure or kill an unborn baby; stop it as soon as possible and call your prescriber if you become pregnant.
Clinical pearls
- Call 911 for swelling of the lips, tongue or throat; with ACE inhibitors this can appear even after long, trouble-free use.
- Skip potassium salt substitutes and potassium supplements unless your prescriber approves, since trandolapril already pushes potassium up.
- Switching to or from Entresto requires a 36-hour gap without trandolapril, because overlap raises the risk of dangerous swelling.
- Tell your allergist or dialysis team you take it, since bee venom allergy shots and high-flux dialysis have triggered serious reactions.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Trandolapril can cause serious harm or death to an unborn baby. If you become pregnant while taking trandolapril, stop it as soon as possible and contact your doctor right away. This risk is greatest during the second and third trimesters of pregnancy, when the drug can damage the baby's kidneys, cause very low amniotic fluid (oligohydramnios), and lead to skull defects, kidney failure, low blood pressure, or death in the newborn. Use reliable contraception while taking this medicine, and tell your doctor immediately if you think you might be pregnant.
Patient information guide A plain-language walkthrough of Trandolapril, written from its FDA label.
What Trandolapril is used for
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Trandolapril tablets are an ACE inhibitor approved for two main uses:
- High blood pressure (hypertension): Trandolapril tablets can be used alone or combined with other antihypertensive medicines such as hydrochlorothiazide to bring blood pressure under control.
- Heart failure or left-ventricular dysfunction after a heart attack: Trandolapril tablets are approved for stable patients who, within the first few days after a heart attack, show reduced pumping function of the left ventricle (the heart's main pumping chamber) or have symptoms of heart failure. In Caucasian patients, this has been shown to lower the risk of cardiovascular death and reduce heart failure–related hospital stays.
How Trandolapril works
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Trandolapril is a prodrug — after you swallow it, your liver converts it into the active form, trandolaprilat. Trandolaprilat blocks an enzyme called ACE (angiotensin-converting enzyme), which normally produces angiotensin II, a chemical that tightens blood vessels and signals the body to retain sodium and water. By blocking this step, trandolapril widens blood vessels, lowers blood pressure, and reduces the workload on the heart. It also lowers levels of aldosterone (a hormone that causes the body to hold onto salt and fluid) and allows a mild increase in potassium.
Trandolapril lowers blood pressure effectively in patients of all races studied, including those whose high blood pressure is not primarily driven by the renin-angiotensin system.
Trandolapril dosage
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Trandolapril tablets are taken by mouth once daily, with or without food. Food slows the rate of absorption slightly but does not change how much of the active medicine ultimately reaches your system. Your prescriber will start you at a low dose and adjust it over at least one-week intervals until your blood pressure or heart condition is well controlled. If once-daily dosing at a higher level isn't enough for blood pressure, your doctor may switch you to twice-daily dosing.
- Take it at the same time each day to keep levels steady.
- Do not stop taking it suddenly without talking to your doctor.
- If you have significant kidney disease or liver cirrhosis, your dose will likely be lower — your prescriber will guide you.
Dosing details from the FDA-approved label
From the Trandolapril prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Hypertension, patients not receiving a diuretic
- Initial dosage 1 mg once daily in non-black patients and 2 mg in black patients
- Adjust according to blood pressure response, generally at intervals of at least 1 week
- Most patients have required 2 to 4 mg once daily
- Patients inadequately treated with once-daily dosing at 4 mg may be treated with twice-daily dosing
- If blood pressure is not controlled with
- Maximum: There is little clinical experience with doses above 8 mg
- Hypertension, patients currently treated with a diuretic
- If possible, discontinue the diuretic two to three days prior to beginning trandolapril tablets, then resume diuretic if blood pressure is not controlled
- If the diuretic cannot be discontinued, initial dose of 0.5 mg with careful medical supervision for several hours until blood pressure has stabilized, then titrate to optimal response
- Symptomatic hypotension occasionally can occur following the initial dose in patients on a diuretic
- Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction
- Starting dose 1 mg once daily
- Following the initial dose, titrate (as tolerated) toward a target dose of 4 mg once daily
- If 4 mg is not tolerated, continue with the greatest tolerated dose
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Hypertension The recommended initial dosage of trandolapril tablets for patients not receiving a diuretic is 1 mg once daily in non-black patients and 2 mg in black patients. Dosage should be adjusted according to the blood pressure response. Generally, dosage adjustments should be made at intervals of at least 1 week. Most patients have required dosages of 2 to 4 mg once daily. There is little clinical experience with doses above 8 mg. Patients inadequately treated with once-daily dosing at 4 mg may be treated with twice-daily dosing. If blood pressure is not adequately controlled with trandolapril tablets monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of trandolapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with trandolapril tablets. (See WARNINGS . ) Then, if blood pressure is not controlled with trandolapril tablets alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 0.5 mg trandolapril tablets should be used with careful medical supervision for several hours until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response. (See WARNINGS , PRECAUTIONS and Drug Interactions . ) Concomitant administration of trandolapril tablets with potassium supplements, potassium salt substitutes, or potassium sparing diuretics can lead to increases of serum potassium. (See PRECAUTIONS . ) Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction The recommended starting dose is 1 mg, once daily. Following the initial dose, all patients should be titrated (as tolerated) toward a target dose of 4 mg, once daily. If a 4 mg dose is not tolerated, patients can continue therapy with the greatest tolerated dose. Dosage Adjustment in Renal Impairment or Hepatic Cirrhosis For patients with a creatinine clearance <30 mL/min. or with hepatic cirrhosis, the recommended starting dose, based on clinical and pharmacokinetic data, is 0.5 mg daily. Patients should subsequently have their dosage titrated (as described above) to the optimal response.
Read the full Dosage and Administration section on DailyMed →
Trandolapril side effects
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Most people tolerate trandolapril well, but some side effects do occur:
Common side effects
- Cough (dry, persistent)
- Dizziness
- Headache
- Fatigue
- Diarrhea
- Low blood pressure (hypotension)
- Elevated potassium levels (hyperkalemia)
- Elevated creatinine or BUN (signs of kidney stress)
- Dry, persistent cough — the most common reason people switch ACE inhibitors
- Dizziness — especially when standing up quickly
When to get medical help
- Call 911 immediately if you develop swelling of the face, lips, tongue, throat, or difficulty breathing — this is angioedema and can be life-threatening
- Call your doctor right away if you feel faint, lightheaded, or have a sudden drop in blood pressure, especially when starting the medicine or after a dose increase
- Tell your doctor immediately if you develop yellowing of the skin or eyes (jaundice) — this may signal a rare but serious liver problem
- Seek care if you have severe abdominal pain with or without nausea — intestinal angioedema (swelling inside the gut) is a rare but serious possibility
- Contact your doctor if you notice signs of high potassium: muscle weakness, irregular heartbeat, or numbness
- Tell your doctor if you develop signs of low white blood cell count (fever, frequent infections), especially if you have kidney disease or a collagen-vascular condition
- Stop trandolapril and contact your doctor immediately if you become pregnant
Trandolapril warnings and precautions
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- Fetal harm (boxed warning): Trandolapril can cause serious injury or death to an unborn baby. Stop it immediately if you become pregnant and contact your doctor right away.
- Angioedema: Swelling of the face, tongue, throat, or intestines can occur and may be life-threatening. Black patients have a higher risk. Risk is also higher if you take mTOR inhibitors or neprilysin inhibitors alongside trandolapril.
- Low blood pressure: Most likely in people who are dehydrated, on diuretics, or who have heart failure. Particularly important to watch in the first weeks of therapy and after dose changes.
- Kidney function changes: Trandolapril can raise creatinine and BUN levels, especially in people with existing kidney disease, renal artery narrowing, or those on diuretics. Monitoring is recommended.
- High potassium (hyperkalemia): Can occur, especially if you also take potassium supplements, salt substitutes, or potassium-sparing diuretics.
- Liver injury: Rarely, ACE inhibitors have caused serious liver problems including jaundice and liver failure. Stop trandolapril and seek medical care if you develop jaundice.
- Low white blood cell count: Rare, but more likely in people with kidney disease or autoimmune conditions. Periodic blood monitoring may be advised.
Trandolapril interactions
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Trandolapril can interact with several medicines and supplements — always give your doctor and pharmacist a full list of everything you take:
- Other RAS-blocking drugs (ARBs like losartan, or aliskiren): Combining these with trandolapril raises the risk of dangerously low blood pressure, high potassium, and kidney failure. Avoid combination use; aliskiren must not be used with trandolapril in people with diabetes.
- Sacubitril/valsartan (Entresto — a neprilysin inhibitor): Do not take trandolapril within 36 hours of switching to or from this medicine due to a significantly increased risk of angioedema. Trandolapril is contraindicated in combination with neprilysin inhibitors.
- Potassium supplements, potassium salt substitutes, or potassium-sparing diuretics (e.g., spironolactone): Can cause potassium to rise to dangerous levels when combined with trandolapril.
- Diuretics (water pills): Can increase the risk of a sudden drop in blood pressure when starting trandolapril. Your doctor may pause the diuretic first or use a lower starting dose.
- mTOR inhibitors (e.g., everolimus, sirolimus, temsirolimus): Increase the risk of angioedema when taken with trandolapril.
- Cimetidine: Can increase trandolapril levels in the blood, though this does not appear to affect ACE inhibition significantly.
Interactions listed in the FDA-approved label
From the Trandolapril prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Digoxin (oral, 0.25 mg): Trandolapril did not affect the plasma concentration (pre-dose and 2 hours post-dose) of oral digoxin.
- Cimetidine: Coadministration led to an increase of about 44% in Cmax for trandolapril, but no difference in the pharmacokinetics of trandolaprilat or in ACE inhibition.
- Furosemide: Coadministration led to an increase of about 25% in the renal clearance of trandolaprilat, but no effect on the pharmacokinetics of furosemide or trandolaprilat or on ACE inhibition.
- Dual blockade of the RAS (angiotensin receptor blockers, ACE inhibitors, aliskiren): Associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy; most patients do not obtain additional benefit. In general, avoid combined use of RAS inhibitors; closely monitor blood pressure, renal function and electrolytes.
- Aliskiren: Dual RAS blockade with aliskiren carries increased risks of hypotension, hyperkalemia, and renal function changes. Do not co-administer with trandolapril tablets in patients with diabetes; avoid use in patients with renal impairment.
- Potassium supplements, potassium salt substitutes, or potassium sparing diuretics: Concomitant administration can lead to increases of serum potassium.
Read the label’s full interactions text
Drug Interactions Trandolapril did not affect the plasma concentration (pre-dose and 2 hours post-dose) of oral digoxin (0.25 mg). Coadministration of trandolapril and cimetidine led to an increase of about 44% in C max for trandolapril, but no difference in the pharmacokinetics of trandolaprilat or in ACE inhibition. Coadministration of trandolapril and furosemide led to an increase of about 25% in the renal clearance of trandolaprilat, but no effect was seen on the pharmacokinetics of furosemide or trandolaprilat or on ACE inhibition.
Drug Interactions Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on trandolapril tablets and other agents that affect the RAS. Do not co-administer aliskiren with trandolapril tablets in patients with diabetes. Avoid use of aliskiren with trandolapril tablets in patients with renal impairment (GFR <60 mL/min). Concomitant Diuretic Therapy As with other ACE inhibitors, patients on diuretics, especially those on recently instituted diuretic therapy, may experience an excessive reduction of blood pressure after initiation of therapy with trandolapril tablets. The possibility of exacerbation of hypotensive effects with trandolapril tablets may be minimized by either discontinuing the diuretic or cautiously increasing salt intake prior to initiation of treatment with trandolapril tablets. If it is not possible to discontinue the diuretic, the starting dose of trandolapril should be reduced.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Trandolapril
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- History of angioedema: Do not take trandolapril if you have ever had angioedema from an ACE inhibitor, or if you have hereditary or unexplained (idiopathic) angioedema — it is contraindicated.
- Pregnancy: Trandolapril must not be used during pregnancy. Use reliable contraception and stop it immediately if you become pregnant.
- Kidney disease: Dose adjustment is needed if your kidney function is significantly reduced; trandolapril and its active metabolite build up to higher levels in this situation.
- Liver disease/cirrhosis: Trandolapril levels can be much higher in people with liver cirrhosis; close monitoring and possible dose adjustment are needed.
- Diabetes with aliskiren use: Do not combine trandolapril with aliskiren if you have diabetes.
- Dialysis patients: Serious allergic-type (anaphylactoid) reactions have been reported in people dialyzed with high-flux membranes while on ACE inhibitors.
- Allergy desensitization: Life-threatening reactions have occurred in people receiving venom desensitization (e.g., bee sting allergy shots) while on ACE inhibitors.
- Autoimmune or collagen-vascular diseases (e.g., lupus, scleroderma) with kidney disease: Higher risk of very low white blood cell count; periodic monitoring of blood counts may be recommended.
- Older adults: Higher trandolapril blood levels have been observed in elderly patients, though ACE-inhibitory activity appears similar to younger patients.
- Children: Trandolapril pharmacokinetics have not been evaluated in pediatric patients.
Trandolapril overdose
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If too much trandolapril is taken, the most likely effects are a severe drop in blood pressure, high potassium levels, and kidney problems. There is no specific antidote readily available, but a saline (salt water) IV infusion is a reasonable first step to counter the blood pressure drop. The active metabolite trandolaprilat can be removed by hemodialysis. If you suspect an overdose, call Poison Control or go to an emergency room right away.
What Trandolapril does in the body
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By blocking ACE, trandolapril reduces the production of angiotensin II — the chemical that tightens blood vessels and stimulates aldosterone release. This leads to widened blood vessels (lower vascular resistance), reduced sodium and water retention, and a modest increase in blood potassium. Clinical trials showed a mean increase in potassium of about 0.1 mEq/L with trandolapril alone. These combined effects lower blood pressure and, after a heart attack, reduce the stress placed on the heart.
How your body processes Trandolapril
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After you swallow trandolapril, it is absorbed and converted — primarily in the liver — into its active form, trandolaprilat, which is about eight times more potent as an ACE inhibitor. Peak levels of the active form are reached within 4 to 10 hours after a dose. The effective half-life (the time it takes the body to clear half of the active drug at steady state) is about 22.5 hours, which supports once-daily dosing. About one-third of the drug and its breakdown products leave the body in urine, and about two-thirds in the stool. In people with significant kidney impairment or liver cirrhosis, drug levels can be considerably higher, which is why dose adjustments are needed in those groups.
How to store Trandolapril
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Dispense in well-closed container with safety closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Trandolapril
149 supplements and herbal products have documented interactions with Trandolapril in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 119
- Minor · 24
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Trandolapril has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Trandolapril: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Trandolapril — the kind of thing our pharmacy team would talk through with you at the counter.
What is trandolapril actually used for?
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Will I get that annoying cough everyone talks about with ACE inhibitors?
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Is it safe to take if I'm pregnant or trying to get pregnant?
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What side effects should actually make me call the doctor or go to the ER?
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Are there any medicines or supplements I should avoid while on trandolapril?
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Does it matter if I take trandolapril with food or at a specific time of day?
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Is Trandolapril available over the counter?
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When was Trandolapril first available?
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Who makes Trandolapril?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Trandolapril on HelloPharmacist
Trandolapril forms and strengths (how it comes)
Trandolapril is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Trandolapril inactive ingredients by manufacturer.
Tablet
How this form is used
- Trandolapril tablets are used to treat high blood pressure (hypertension), alone or with other blood pressure medicines
- Trandolapril tablets are used after a heart attack in stable patients with left-ventricular dysfunction or heart failure symptoms to reduce the risk of cardiovascular death and hospitalization
- Trandolapril tablets are taken by mouth once daily; your doctor may adjust to twice daily if needed for blood pressure control
- Trandolapril tablets can be taken with or without food — food slows absorption slightly but does not affect overall effectiveness
- If you are on a diuretic (water pill), your doctor may pause it a few days before you start Trandolapril tablets to reduce the risk of a sudden drop in blood pressure
- Trandolapril tablets require dose adjustment in patients with significant kidney impairment or liver cirrhosis — follow your prescriber's specific instructions
Trandolapril on the U.S. market: products, makers and brands
How Trandolapril appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
5 companies list 14 Trandolapril product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1996. Brand names on the directory include Mavik; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Trandolapril is used (Medicaid data)
A general measure of how commonly Trandolapril is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Trandolapril is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Trandolapril prescribed? Of the 1,601 medications we measure, Trandolapril ranks #1,498 by Medicaid prescriptions — more than 6% of them.
Utilization by Trandolapril product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
trandolapril 4 MG Oral Tablet Most dispensed
Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199352
trandolapril 1 MG Oral Tablet
Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199353
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Trandolapril, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 18 listed Trandolapril NDCs with Medicaid activity.
Compare Trandolapril products
A representative set of FDA-listed product records for Trandolapril — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 1 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 4 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 2 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 4 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 1 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 4 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 4 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Trandolapril NDCs →
Trandolapril side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Trandolapril — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Trandolapril in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Trandolapril FDA approval history
How Trandolapril went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Trandolapril recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Trandolapril recalls since July 2021.
✅No Trandolapril recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 38454 2 dose forms · 7 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 374176No current FDA listingClinical drug / strength (SCD) 0.5 MGRxCUI 1996221 MGRxCUI 1998162 MGRxCUI 1998174 MGRxCUI 411434 -
Dose form (SCDF) Oral Tablet RxCUI 374177In current FDA listings
Look up RxCUI 38454 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Trandolapril supply and shortage status
Whether Trandolapril is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Trandolapril brand names
Trandolapril is sold under one brand name in the FDA directory — Mavik. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Trandolapril: manufacturers and labelers
5 companies list Trandolapril products with the FDA. By number of product records, the largest are Aurobindo Pharma Limited, Epic Pharma, LLC, Lupin Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Trandolapril drug class (RxNorm)
Trandolapril belongs to the Angiotensin Converting Enzyme Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Trandolapril page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Rising Health, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →