Prescription medicine
Amlodipine and telmisartan First approved as Twynsta
Amlodipine and telmisartan (Twynsta) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $2.88 per unit (Telmisartan-amlodipine 40-10) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and telmisartan FDA label on DailyMed (effective January 30, 2023, Alembic Pharmaceuticals Limited); the NDA 22401 record on Drugs@FDA; every amlodipine and telmisartan label on DailyMed.
Highlights of the record
FDA label of January 30, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible [see Warnings and Precautions (5.1)]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue t elmisartan and amlodipine tablets as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus
Used for
From the label: indications and usageTelmisartan and amlodipine tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to lower blood pressure.
Forms and strengths
- 40 mg / 5 mg
- 40 mg / 10 mg
- 80 mg / 10 mg
- 80 mg / 5 mg
Tablet.
On the market
- Earliest approval on file
- October 16, 2009 Twynsta, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first January 8, 2014; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.88 per unit Telmisartan-amlodipine 40-10
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2019 0 Class I among all firms' recalls; latest April 3, 2019
- FAERS reports
- 98 through July 30, 2026
What is amlodipine and telmisartan used for?
From the label: indications and usageTelmisartan and amlodipine tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers and dihydropyridine calcium channel blockers. There are no controlled trials demonstrating risk reduction with telmisartan and amlodipine tablets. […]
Conditions named in the indications of amlodipine and telmisartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker, Calcium Channel Blocker and Dihydropyridine Calcium Channel Blocker.
Source: FDA drug label (Telmisartan and Amlodipine), Alembic Pharmaceuticals Limited, effective January 30, 2023 (SPL set 15b438b4-4874-43f4-a50a-4e6f3e5530ac), via openFDA; the full label on DailyMed
What does the patient leaflet for amlodipine and telmisartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about telmisartan and amlodipine tablets?Telmisartan and amlodipine tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking telmisartan and amlodipine tablets, tell your doctor right away.
From the patient leaflet: How should I store telmisartan and amlodipine tablets?Store telmisartan and amlodipine tablets at room temperature 20 ° to 25 ° C (68 ° to 77 ° F). • Do not remove telmisartan and amlodipine tablets from bottles until right before you take them. • Keep telmisartan and amlodipine tablets out of the light and away from moisture. Keep telmisartan and amlodipine tablets and all medicines out of the reach of children.
Source: FDA drug label (Telmisartan and Amlodipine), Mylan Pharmaceuticals Inc., effective November 14, 2018 (SPL set ca60a4d5-ace7-4889-94ee-e2265fd63811), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and telmisartan (Twynsta)?
The FDA approved the first generic amlodipine and telmisartan on January 8, 2014. 4 generic applications are approved; 1 of them 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 amlodipine and telmisartan from 3 labelers 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.
- 2009 earliest approval on file
- 2014 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amlodipine and telmisartan (Twynsta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.88 per unit (Telmisartan-amlodipine 40-10), up 16% from $2.49 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Telmisartan-amlodipine 80-5 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Telmisartan-amlodipine 40-10 | Generic | $2.88 per unit | n/a | +16% |
| Telmisartan-amlodipine 40-5 mg | Generic | $3.19 per unit | n/a | +14% |
| Telmisartan-amlodipine 80-10 | Generic | $2.94 per unit | n/a | -10% |
| Telmisartan-amlodipine 80-5 mg | Generic | $2.87 per unit | n/a | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amlodipine and telmisartan been recalled?
The FDA's Enforcement Report lists 2 recalls naming amlodipine and telmisartan since 2019: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 3, 2019 | Class III | AVKARE Inc. | Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) |
| April 1, 2019 | Class III | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications; 18 month long term stability study. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amlodipine and telmisartan label say about other medicines?
The amlodipine and telmisartan label names 26 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 |
|---|---|---|
| Acetaminophen | drug interactions | Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. |
| Aliskiren | contraindications | Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes [see Drug Interactions (7.2)]. |
| Atorvastatin | drug interactions | Amlodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin. |
| Carbamazepine | drug interactions | CYP3A4 Inducers No information is available on the quantitative effects of CYP3A4 inducers ( e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone, rifampicin, St. John’s Wort) on amlodipine. |
| Cimetidine | drug interactions | The following have no clinically relevant effects on the pharmacokinetics of amlodipine: cimetidine, grapefruit juice, magnesium and aluminum hydroxide antacid, sildenafil. |
| Cyclosporine | drug interactions | Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. |
| Digoxin | drug interactions | When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. |
| Diltiazem | drug interactions | CYP3A4 Inhibitors Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. |
| Erythromycin | drug interactions | Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure. |
| Fosphenytoin | drug interactions | CYP3A4 Inducers No information is available on the quantitative effects of CYP3A4 inducers ( e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone, rifampicin, St. John’s Wort) on amlodipine. |
| Glyburide | drug interactions | Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. |
| Hydrochlorothiazide | drug interactions | Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. |
| Ibuprofen | drug interactions | Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. |
| Itraconazole | drug interactions | However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent. |
Every other medicine the amlodipine and telmisartan label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent. |
| Lithium | drug interactions | Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan. |
| Nitroglycerin | drug interactions | … angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs. |
| Phenobarbital | drug interactions | CYP3A4 Inducers No information is available on the quantitative effects of CYP3A4 inducers ( e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone, rifampicin, St. … |
| Phenytoin | drug interactions | CYP3A4 Inducers No information is available on the quantitative effects of CYP3A4 inducers ( e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone, rifampicin, St. … |
| Primidone | drug interactions | … inducers ( e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone, rifampicin, St. John’s Wort) on amlodipine. |
| Ramipril | drug interactions | Ramipril and Ramiprilat: Co-administration of telmisartan 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state C max and AUC of ramipril 2.3- and 2.1-fold … |
| Ritonavir | drug interactions | However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent. |
| Sildenafil | drug interactions | The following have no clinically relevant effects on the pharmacokinetics of amlodipine: cimetidine, grapefruit juice, magnesium and aluminum hydroxide antacid, sildenafil. |
| Simvastatin | drug interactions | DRUG INTERACTIONS NSAIDS: Increased risk of renal impairment and loss of antihypertensive effect (7) If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of … |
| Tacrolimus | drug interactions | Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. |
| Warfarin | drug interactions | Co-administration of telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. |
Source: FDA drug label (Telmisartan and Amlodipine), Alembic Pharmaceuticals Limited, effective January 30, 2023 (SPL set 15b438b4-4874-43f4-a50a-4e6f3e5530ac), via openFDA; the full label on DailyMed
What do FAERS reports show for amlodipine and telmisartan?
The FDA Adverse Event Reporting System holds 98 reports that list amlodipine and telmisartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 48 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 amlodipine and telmisartan?
62 other medicines are given the same way (oral) and in the same FDA class as amlodipine and telmisartan 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 |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Nifedipine | High blood pressure | 32 labelers | $0.130 per tablet 30 mg tablet | No current entry |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and losartan | High blood pressure | 29 labelers | $0.0762 per tablet 100-12.5 mg tablet | No current entry |
| Hydrochlorothiazide and valsartan | High blood pressure | 18 labelers | $0.101 per tablet 160-12.5 mg tablet | No current entry |
| Verapamil | High blood pressure | 24 labelers | $0.191 per tablet 180 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as amlodipine and telmisartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amlodipine and telmisartan
- 62 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Amlodipine and telmisartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other