Quick answers
- What is Telmisartan and amlodipine used for?
- The FDA-approved label (Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., November 14, 2018) says: “Telmisartan 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Telmisartan and amlodipine?
- The “Adverse Reactions” section of the FDA label (Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., November 14, 2018) begins: “• In the placebo-controlled factorial design study, the most common reasons for discontinuation of therapy with telmisartan and amlodipine tablets were peripheral edema, dizziness, and hypotension, each leading to discontinuation of ≤ 0.5% of telmisartan and amlodipine tablet-treated patients.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Telmisartan and amlodipine?
- The “Drug Interactions” section of the FDA label (Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., November 14, 2018) begins: “• 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 simvastatin. (7) • Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes. (7.2) 7.1 Drug Interactions with Telmisartan and Amlodipine Tablets The pharmacokinetics of amlodipine and telmisartan are not altered when the drugs are co-administered.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Telmisartan and amlodipine have a boxed warning?
- Yes. The FDA label for Telmisartan and Amlodipine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Telmisartan and amlodipine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Telmisartan and amlodipine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 1, 2019 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Telmisartan and amlodipine?
- 4 companies list prescription products of Telmisartan and amlodipine in the FDA NDC Directory, including Alembic Pharmaceuticals Inc., Mylan Pharmaceuticals Inc. and Alembic Pharmaceuticals Limited.
What Telmisartan and amlodipine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Telmisartan 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. …
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc.; it covers 4 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Telmisartan and amlodipine boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue telmisartan and amlodipine tablets 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 warning.
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- When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible (5.1, 8.1)
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1, 8.1)
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. Read the full label on DailyMed →
Telmisartan and amlodipine side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
- In the placebo-controlled factorial design study, the most common reasons for discontinuation of therapy with telmisartan and amlodipine tablets were peripheral edema, dizziness, and hypotension, each leading to discontinuation of ≤ 0.5% of telmisartan and amlodipine tablet-treated patients.
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Adverse reactions that occurred at a ≥ 2% higher incidence on telmisartan and amlodipine tablets than placebo were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), and back pain (2.2% vs 0%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Telmisartan and Amlodipine Tablets The concomitant use of telmisartan and amlodipine has been evaluated for safety in more than 3700 patients with hypertension; approximately 1900 of these patients were exposed for at least 6 months and over 160 of these patients were exposed for at least 1 year. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. In the placebo-controlled factorial design study, the population treated with a telmisartan and amlodipine combination had a mean age of 53 years and included approximately 50% males, 79% were Caucasian, 17% Blacks, and 4% Asians. Patients received doses ranging from 20/2.5 mg to 80/10 mg orally, once daily. The frequency of adverse reactions was not related to gender, age, or race. The adverse reactions that occurred in the placebo-controlled factorial design trial in ≥ 2% of patients treated with telmisartan and amlodipine tablets and at a higher incidence in telmisartan and amlodipine tablet-treated patients (n = 789) than placebo-treated patients (n = 46) were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), and back pain (2.2% vs 0%). Edema (other than peripheral edema), hypotension, and syncope were reported in < 2% of patients treated with telmisartan and amlodipine tablets. In the placebo-controlled factorial design trial, discontinuation due to adverse events occurred in 2.2% of all treatment cells of patients in the telmisartan/amlodipine-treated patients and in 4.3% in the placebo-treated group. The most common reasons for discontinuation of therapy with telmisartan and amlodipine tablets were peripheral edema, dizziness, and hypotension (each ≤ 0.5%). Peripheral edema is a known, dose-dependent adverse reaction of amlodipine, but not of telmisartan. In the factorial design study, the incidence of peripheral edema during the 8-week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy.
Table from the label
| Telmisartan | ||||
|---|---|---|---|---|
| Placebo | 40 mg | 80 mg | ||
| Amlodipine | Placebo | 0% | 0.8% | 0.7% |
| 5 mg | 0.7% | 1.4% | 2.1% | |
| 10 mg | 17.8% | 6.2% | 11.3% |
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. This is part of the section. Read the full label on DailyMed →
Telmisartan and amlodipine drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
- 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 simvastatin. (7)
- Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes. (7.2) 7.1 Drug Interactions with Telmisartan and Amlodipine Tablets The pharmacokinetics of amlodipine and telmisartan are not altered when the drugs are co-administered.
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No drug interaction studies have been conducted with telmisartan and amlodipine tablets and other drugs, although studies have been conducted with the individual amlodipine and telmisartan components of telmisartan and amlodipine tablets, as described below: 7.2 Drug Interactions with Telmisartan Aliskiren Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes. Avoid use of aliskiren with telmisartan and amlodipine tablets in patients with renal impairment (GFR < 60 mL/min). Digoxin When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan for the purpose of keeping the digoxin level within the therapeutic range. Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan. Therefore, monitor serum lithium levels during concomitant use. Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving telmisartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors. 7.3 Drug Interactions with Amlodipine In clinical trials, amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs. Simvastatin Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus and dose adjustment when appropriate is recommended.
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. This is part of the section. Read the full label on DailyMed →
Telmisartan and amlodipine dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
- Substitute telmisartan and amlodipine tablets for its individually titrated components for patients on amlodipine and telmisartan. Telmisartan and amlodipine tablets may also be given with increased amounts of amlodipine, telmisartan, or both, as needed.
Read more of this section
(2.2, 2.3)
- Use telmisartan and amlodipine tablets to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone. (2.3)
- Dosage may be increased after at least 2 weeks to a maximum dose of 80/ 10 mg once daily, usually by increasing one component at a time but both components can be raised to achieve more rapid control. (2.1, 2.2)
- Majority of antihypertensive effect is attained within 2 weeks. (2.1)
- Initiate with 40/5 mg or 80/5 mg once daily. (2.4)
- Switch patients who experience dose-limiting adverse reactions on amlodipine to telmisartan and amlodipine tablets containing a lower dose of that component. (2.3) 2.1 General Considerations Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is effective in doses of 2.5 to 10 mg. Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of telmisartan and amlodipine tablets is 80/10 mg once daily. The adverse reactions of telmisartan are uncommon and independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter [see Adverse Reactions (6.1)]. Telmisartan and amlodipine tablets may be taken with or without food. 2.2 Replacement Therapy Patients receiving amlodipine and telmisartan from separate tablets may instead receive telmisartan and amlodipine tablets containing the same component doses once daily. When substituting for individual components, increase the dose of telmisartan and amlodipine tablets if blood pressure control has not been satisfactory. 2.3 Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Antihypertensive Monotherapy Telmisartan and amlodipine tablets may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone.
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. This is part of the section. Read the full label on DailyMed →
Telmisartan and amlodipine in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Telmisartan and amlodipine tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations).
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Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data). In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose (see Data). When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major malformations and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking telmisartan and amlodipine tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue telmisartan and amlodipine tablets, unless it is considered lifesaving for the mother.
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. This is part of the section. Read the full label on DailyMed →
When Telmisartan and amlodipine should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Telmisartan and amlodipine tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, or any other component of this product [see Adverse Reactions (6.2)]. Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes [see Drug Interactions (7.2)].
- Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine or any other component of this product.
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(4)
- Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes. (4)
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. Read the full label on DailyMed →
Telmisartan and amlodipine overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Telmisartan Limited data are available with regard to overdosage in humans. The most likely manifestations of overdosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.
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Amlodipine Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
— FDA label: Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 14 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| amlodipine besylate 10 mg · telmisartan 40 mg tablet | Generic | $2.84 per tablet |
| amlodipine besylate 10 mg · telmisartan 80 mg tablet | Generic | $2.91 per tablet |
| amlodipine besylate 5 mg · telmisartan 40 mg tablet | Generic | $3.25 per tablet |
| amlodipine besylate 5 mg · telmisartan 80 mg tablet | Generic | $2.83 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Alembic Pharmaceuticals Inc.4 products
- Mylan Pharmaceuticals Inc.4 products
- Alembic Pharmaceuticals Limited4 products
- Lupin Pharmaceuticals, Inc.2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA201586Lupin · January 8, 2014
- ANDA202516Mylan · August 26, 2014
- ANDA205234Alembic · November 17, 2016
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 1, 2019 · Class III · Terminated · D-1121-2019
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06 — Lupin Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 876514, 876519, 876524, 876529 |
|---|---|
| SPL set ID of the quoted label | ca60a4d5-ace7-4889-94ee-e2265fd63811 |
| FDA labels (SPL) | 2 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | AMLODIPINE / TELMISARTAN |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Alembic Pharmaceuticals Inc.Maker or distributor
- Mylan Pharmaceuticals Inc.Maker or distributor
- Alembic Pharmaceuticals LimitedMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Telmisartan and Amlodipine, Mylan Pharmaceuticals Inc., effective November 14, 2018; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →