Prescription medicine
Telmisartan First approved as Micardis
Telmisartan (Micardis) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.106 per telmisartan 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the telmisartan FDA label on DailyMed (effective May 29, 2026, Alembic Pharmaceuticals Limited); the NDA 20850 record on Drugs@FDA; every telmisartan label on DailyMed.
Highlights of the record
FDA label of May 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warnings. When pregnancy is detected, discontinue telmisartan as soon as possible (5.1, 8.1) Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus
Used for
From the label: indications and usageTelmisartanis an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension to lower blood pressure.
Forms and strengths
- 20 mg
- 40 mg
- 80 mg
Tablet.
On the market
- Earliest approval on file
- November 10, 1998 Micardis, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first January 8, 2014; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 28 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.106 per tablet Telmisartan 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2016 1 Class I among all firms' recalls; latest February 9, 2024
- FAERS reports
- 17,745 through July 30, 2026
What is telmisartan used for?
From the label: indications and usageTelmisartanis an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions(1.1) 1.1 Hypertension Telmisartan is indicated for the treatment of hypertension, 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 the class to which this drug principally belongs. […]
Conditions named in the indications of telmisartan's FDA labels, with every medicine labeled for each:
From other telmisartan labelsHeart attack and coronary artery disease: Telmisartan tablets are indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to …
FDA pharmacologic class: Angiotensin 2 Receptor Blocker.
Source: FDA drug label (Telmisartan), Alembic Pharmaceuticals Limited, effective May 29, 2026 (SPL set 4be6575f-ea8d-4cd8-a49d-3d1c93f2621a), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 tablets?Telmisartan 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, tell your doctor right away.
From the patient leaflet: How should I store telmisartan tablets?Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). • Do not remove telmisartan tablets from bottles until right before you take them. • Bottle of 30’s count comes in a child-resistant package. Keep telmisartan tablets and all medicines out of the reach of children.
Source: FDA drug label (Telmisartan), Alembic Pharmaceuticals Limited, effective May 29, 2026 (SPL set 4be6575f-ea8d-4cd8-a49d-3d1c93f2621a), via openFDA; the full label on DailyMed
Is there a generic for telmisartan (Micardis)?
The FDA approved the first generic telmisartan on January 8, 2014. 18 generic applications are approved; 15 of them carry 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 telmisartan from 28 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.
- 1998 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 telmisartan (Micardis)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.106 per Telmisartan 20 mg tablet, down 4% from $0.111 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 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Telmisartan 20 mg tablet | Generic | $0.106 per tablet | $3.17 | -4% |
| Telmisartan 40 mg tablet | Generic | $0.150 per tablet | $4.51 | -17% |
| Telmisartan 80 mg tablet | Generic | $0.163 per tablet | $4.90 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has telmisartan been recalled?
The FDA's Enforcement Report lists 3 recalls naming telmisartan since 2016: 1 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 9, 2024 | Class II | Micro Labs Limited | Failed Stability Specifications: Out of specification for blend uniformity. |
| March 17, 2021 | Class I | Alembic Pharmaceuticals Limited | Labeling: Label-mixup |
| February 25, 2016 | Class III | Torrent Pharmaceuticals Limited | Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the telmisartan label say about other medicines?
The telmisartan label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name telmisartan. 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 telmisartan in patients with diabetes [see Drug Interactions (7)]. |
| 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. |
| 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. |
| Ramipril | warnings and precautions | Patients receiving the combination of telmisartan and ramipril did not obtain any additional benefit compared to monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acute renal failure) compared with groups receiving telmisartan alone or ramipril alone. |
Other labels that name telmisartan
Source: FDA drug label (Telmisartan), Alembic Pharmaceuticals Limited, effective May 29, 2026 (SPL set 4be6575f-ea8d-4cd8-a49d-3d1c93f2621a), via openFDA; the full label on DailyMed
What do FAERS reports show for telmisartan?
The FDA Adverse Event Reporting System holds 17,745 reports that list telmisartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,706 are coded as a death and 8,092 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.
Reports received each year
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 telmisartan?
69 other medicines are given the same way (oral) and in the same FDA class as 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Irbesartan | High blood pressure | 23 labelers | $0.107 per tablet 150 mg tablet | No current entry |
| Hydrochlorothiazide and olmesartan | High blood pressure | 17 labelers | $0.165 per tablet 20-12.5 mg tablet | No current entry |
| Amlodipine and olmesartan | High blood pressure | 14 labelers | $0.248 per unit 10-20 mg | No current entry |
Every medicine labeled for the same conditions as telmisartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does telmisartan compare with medicines for the same use?
27 side-by-side pages set telmisartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to telmisartan
- 69 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Telmisartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other