Prescription medicine
Trandolapril and verapamil First approved as Tarka
Trandolapril and verapamil (Tarka) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the trandolapril and verapamil FDA label on DailyMed (effective January 29, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 20591 record on Drugs@FDA; every trandolapril and verapamil label on DailyMed.
Highlights of the record
FDA label of January 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
FETAL TOXICITY •.
When pregnancy is detected, discontinue trandolapril and verapamil hydrochloride extended-release tablets as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS: Fetal Toxicity ).
Used for
From the label: indications and usageTrandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension.
Forms and strengths
- 1 mg / 240 mg
- 2 mg / 240 mg
- 2 mg / 180 mg
- 4 mg / 240 mg
Film-coated extended-release tablet.
On the market
- Earliest approval on file
- October 22, 1996 Tarka, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first May 5, 2010; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 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)
- 1 since 2023 0 Class I among all firms' recalls; latest August 14, 2023
- FAERS reports
- 55 through July 30, 2026
What is trandolapril and verapamil used for?
From the label: indications and usageTrandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see WARNINGS - Neutropenia/Agranulocytosis ).
Conditions named in the indications of trandolapril and verapamil's FDA labels, with every medicine labeled for each:
From other trandolapril and verapamil labelsHigh blood pressure: INDICATIONS AND USAGE Trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor and Calcium Channel Blocker.
Source: FDA drug label (Trandolapril and Verapamil Hydrochloride), Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026 (SPL set 39bad727-af4c-4d20-933b-7f287e88099a), via openFDA; the full label on DailyMed
Is there a generic for trandolapril and verapamil (Tarka)?
The FDA approved the first generic trandolapril and verapamil on May 5, 2010. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists trandolapril and verapamil from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has trandolapril and verapamil been recalled?
The FDA's Enforcement Report lists 1 recall naming trandolapril and verapamil since 2023: 0 Class I (the most serious), 0 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 14, 2023 | Class III | Glenmark Pharmaceuticals Inc., USA | Subpotent: Out of Specification for Assay Test at the 3-month time point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the trandolapril and verapamil label say about other medicines?
The trandolapril and verapamil label names 45 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not co-administer aliskiren with trandolapril and verapamil hydrochloride extended-release tablets in patients with diabetes (see PRECAUTIONS - Drug Interactions ). |
| Almotriptan | drug interactions | Tranquilizers/Anti-Depressants Due to metabolism via the CYP enzyme system, there have been reports that verapamil may increase the concentrations of buspirone, midazolam, almotriptan and imipramine. |
| Amiloride | drug interactions | Use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes concomitantly with ACE inhibitors can increase the risk of hyperkalemia. |
| Atorvastatin | drug interactions | Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs. |
| Buspirone | drug interactions | Tranquilizers/Anti-Depressants Due to metabolism via the CYP enzyme system, there have been reports that verapamil may increase the concentrations of buspirone, midazolam, almotriptan and imipramine. |
| Captopril | warnings | Neutropenia/Agranulocytosis Trandolapril Component Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression rarely in patients with uncomplicated hypertension, but more frequently in patients with renal impairment, especially if they also have a collagen-vascular disease … |
| Carbamazepine | drug interactions | Carbamazepine Verapamil may increase carbamazepine concentrations during combined therapy. |
| Cimetidine | drug interactions | No clinically significant pharmacokinetic interaction has been found between trandolapril (or its metabolites) and cimetidine. |
| Clarithromycin | drug interactions | Clarithromycin Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent clarithromycin. |
| Colchicine | drug interactions | When verapamil and colchicine are administered together, the potential inhibition of P-gp and/or CYP3A by verapamil may lead to increased exposure to colchicine (see PRECAUTIONS - Drug Interactions ). |
| Dabigatran | drug interactions | Dabigatran Verapamil, a P-gp inhibitor, increases exposure to dabigatran (a thrombin inhibitor) when administered concomitantly; however, no dose adjustment of dabigatran is required when administered with verapamil. |
| Digoxin | drug interactions | Digitalis Clinical use of verapamil in digitalized patients has shown the combination to be well tolerated if digoxin doses are properly adjusted. |
| Disopyramide | drug interactions | Therefore, disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration. |
| Doxorubicin | drug interactions | Concentrations of doxorubicin may be increased by the administration of verapamil. |
Every other medicine the trandolapril and verapamil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings | … obstruction, emergency therapy, including but not limited to subcutaneous epinephrine solution 1:1,000 (0.3 to 0.5 mL) should be promptly administered (see PRECAUTIONS and ADVERSE REACTIONS ). |
| Erythromycin | drug interactions | Clinically significant interactions have been reported with inhibitors of CYP3A4 (e.g. erythromycin, ritonavir) causing elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g. … |
| Everolimus | drug interactions | Mammalian Target of Rapamycin (mTOR) Inhibitors Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see WARNINGS - … |
| Flecainide | drug interactions | Flecainide A study of healthy volunteers showed that the concomitant administration of flecainide and verapamil may have additive effects on myocardial contractility, AV conduction, and … |
| Flibanserin | contraindications | Patients taking flibanserin (see PRECAUTIONS - Drug Interactions ). |
| Furosemide | drug interactions | No clinically significant pharmacokinetic interaction has been found between trandolapril (or its metabolites) and furosemide. |
| Glyburide | drug interactions | There have been reports that verapamil may elevate the concentrations of the oral anti-diabetic glyburide. |
| Imipramine | drug interactions | Tranquilizers/Anti-Depressants Due to metabolism via the CYP enzyme system, there have been reports that verapamil may increase the concentrations of buspirone, midazolam, almotriptan and imipramine. |
| Ivabradine | drug interactions | Ivabradine Concurrent use of verapamil increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid co-administration of verapamil and ivabradine. |
| Lithium | drug interactions | Lithium Verapamil Component Increased sensitivity to the effects of lithium (neurotoxicity) has been reported during concomitant verapamil-lithium therapy with either no change or an increase in … |
| Lovastatin | drug interactions | Limit the daily dose of lovastatin to 40 mg. |
| Metoprolol | drug interactions | Drug interaction studies have indicated that the maximum concentrations of metoprolol and propanolol are increased after the administration of verapamil. |
| Midazolam | drug interactions | Tranquilizers/Anti-Depressants Due to metabolism via the CYP enzyme system, there have been reports that verapamil may increase the concentrations of buspirone, midazolam, almotriptan and imipramine. |
| Nifedipine | drug interactions | Other (Trandolapril Component) No clinically significant pharmacokinetic interaction has been found between trandolapril (or its metabolites) and nifedipine. |
| Phenobarbital | drug interactions | Barbiturates Phenobarbital therapy may increase verapamil clearance. |
| Prazosin | drug interactions | There are reports that verapamil may result in higher concentrations of the alpha-agonists prazosin and terazosin. |
| Propranolol | warnings | … hypertrophic cardiomyopathy (most of them refractory or intolerant to propranolol) who received therapy with verapamil at doses up to 720 mg/day, a variety of serious adverse effects were seen. |
| Quinidine | drug interactions | Quinidine In a small number of patients with hypertrophic cardiomyopathy (IHSS), concomitant use of verapamil and quinidine resulted in significant hypotension. |
| Rifampin | drug interactions | … elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g. rifampin) have caused a lowering of plasma levels of verapamil. |
| Ritonavir | drug interactions | Clinically significant interactions have been reported with inhibitors of CYP3A4 (e.g. erythromycin, ritonavir) causing elevation of plasma levels of verapamil while inducers of CYP3A4 (e.g. … |
| Sacubitril and valsartan | contraindications | Do not administer trandolapril and verapamil hydrochloride extended-release tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS ). |
| Simvastatin | drug interactions | Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. |
| Sirolimus | drug interactions | Immunosuppressive Agents Verapamil therapy may increase serum levels of cyclosporin, sirolimus and tacrolimus. |
| Spironolactone | drug interactions | Use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes concomitantly with ACE inhibitors can increase the risk … |
| Tacrolimus | drug interactions | Immunosuppressive Agents Verapamil therapy may increase serum levels of cyclosporin, sirolimus and tacrolimus. |
| Temsirolimus | drug interactions | Mammalian Target of Rapamycin (mTOR) Inhibitors Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see WARNINGS - … |
| Terazosin | drug interactions | There are reports that verapamil may result in higher concentrations of the alpha-agonists prazosin and terazosin. |
| Theophylline | drug interactions | Theophylline Verapamil therapy may inhibit the clearance and increase the plasma levels of theophylline. |
| Timolol | drug interactions | Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil. |
| Triamterene | drug interactions | Use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes concomitantly with ACE inhibitors can increase the risk … |
| Warfarin | drug interactions | The anticoagulant effect of warfarin was not significantly changed by trandolapril. |
Source: FDA drug label (Trandolapril and Verapamil Hydrochloride), Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026 (SPL set 39bad727-af4c-4d20-933b-7f287e88099a), via openFDA; the full label on DailyMed
What do FAERS reports show for trandolapril and verapamil?
The FDA Adverse Event Reporting System holds 55 reports that list trandolapril and verapamil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 21 are coded as a death and 25 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 else is labeled for the same conditions as trandolapril and verapamil?
70 other medicines are given the same way (oral) and in the same FDA class as trandolapril and verapamil or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Lisinopril | High blood pressure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Amlodipine | High blood pressure | 42 labelers | $0.0102 per tablet 5 mg tablet | No current entry |
| Enalapril | High blood pressure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
| Hydrochlorothiazide and lisinopril | High blood pressure | 27 labelers | $0.0293 per tablet 10-12.5 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Benazepril | High blood pressure | 21 labelers | $0.0789 per tablet 20 mg tablet | No current entry |
| Amlodipine and atorvastatin | High blood pressure | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
Every medicine labeled for the same conditions as trandolapril and verapamil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trandolapril and verapamil
- 70 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Trandolapril and verapamil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other