Plain-language summary, compiled from the cited regulatory records
Telmisartan is an angiotensin II receptor blocker (ARB) [1]. It is approved for treating hypertension, which is high blood pressure [1]. By lowering blood pressure, telmisartan helps to reduce the risk of cardiovascular events, such as strokes and heart attacks [1]. Telmisartan is also indicated for cardiovascular risk reduction in individuals who cannot take ACE inhibitors [1].
In the past 12 months, there have been 1668 adverse event reports associated with telmisartan [2]. Common adverse events reported include fatigue, nausea, headache, asthenia, and falls [N].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 22, 2026[1]
Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in adults with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or ii) type 2 diabetes mellitus with documented target organ damage
How to take
CACanada· Health Canada
67 products
Uses
CAOfficial regulatory label· revised November 21, 2025[2]
RIVA-TELMISARTAN/AMLODIPINE (telmisartan/amlodipine besylate) is indicated for: • treatment of mild to moderate essential hypertension for whom combination therapy with telmisartan and amlodipine is appropriate. RIVA-TELMISARTAN/AMLODIPINE is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION).
1 Pediatrics • Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of telmisartan/amlodipine besylate in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics • Geriatrics (> 65 years of age): No dose adjustment is necessary for geriatric patients. It should be recognized, however, that greater sensitivity in some older individuals cannot be ruled out.
EUEuropean Union· EMA
12 products
Uses
EUOfficial regulatory label· revised May 6, 2026[3]
Treatment of essential hypertension. 5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
How to take
EU
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised August 20, 2025[4]
1 INDICATIONS AND USAGE Telmisartan and hydrochlorothiazide tablets are 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 classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Drug interactions
Known interactions involving Telmisartan. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 451. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02559854 · revised November 21, 2025
[3]European Medicines Agency · EMEA/H/C/002549 · revised May 6, 2026
[4]FDA DailyMed · 0c1bd0f4-034e-48… · revised August 20, 2025 [PDF]
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology Treatment of essential hypertension The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily.
Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan. 1). Cardiovascular prevention The recommended dose is 80 mg once daily.
It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity. When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.
Special populations Renal impairment:
Limited experience is available in patients with severe renal impairment or haemodialysis. 4). No posology adjustment is required for patients with mild to moderate renal impairment. 3). 4). Elderly No dose adjustment is necessary for elderly patients.
Paediatric population The safety and efficacy of Telmisartan in children and adolescents aged below 18 years have not been established. 2 but no recommendation on a posology can be made. Method of administration Telmisartan tablets are for once-daily oral administration and should be taken with liquid, with or without food.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]
Summary of the safety profile Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000) and acute renal failure. 9 %) in controlled trials in patients treated for hypertension.
The incidence of adverse reactions was not dose related and showed no correlation with gender, age or race of the patients. The safety profile of telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.
The adverse reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports. The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long- term studies including 21,642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Tabulated summary of adverse reactions Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. g. sciatica), muscle spasms, myalgia Rare: Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms) Renal and urinary disorders Uncommon: Renal impairment including acute renal failure General disorders and administration site conditions Uncommon: Chest pain, asthenia (weakness) Rare: Influenza-like illness Investigations Uncommon: Blood creatinine increased Rare: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased 1,2,3,4: for further descriptions, please see sub-section ”Description of selected adverse reactions”.
4). 1 Sepsis In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo. 1). 2 Hypotension This adverse reaction was reported as common in patients with controlled blood pressure who were treated with telmisartan for the reduction of cardiovascular morbidity on top of standard care.
3 Hepatic function abnormal / liver disorder Most cases of hepatic function abnormal / liver disorder from post- marketing experience occurred in Japanese patients. Japanese patients are more likely to experience these adverse reactions.
4 Interstitial lung disease Cases of interstitial lung disease have been reported from post-marketing experience in temporal association with the intake of telmisartan. However, a causal relationship has not been established. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]
Pregnancy Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
6). 3) since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. Telmisartan should be used only with caution in patients with mild to moderate hepatic impairment.
Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin- angiotensin-aldosterone system.
Renal impairment and kidney transplantation When Telmisartan is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Telmisartan in patients with recent kidney transplantation.
Intravascular hypovolaemia Symptomatic hypotension, especially after the first dose of Telmisartan, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Such conditions should be corrected before the administration of Telmisartan. Volume and/or sodium depletion should be corrected prior to administration of Telmisartan. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
g. 8). Primary aldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin- angiotensin system. Therefore, the use of telmisartan is not recommended.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 22, 2026[1]
1).
This is not medical advice. Consult a qualified healthcare professional.
How to take
CAOfficial regulatory label· revised November 21, 2025[2]
). 1 Pediatrics • Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of telmisartan/amlodipine besylate in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics • Geriatrics (> 65 years of age): No dose adjustment is necessary for geriatric patients. It should be recognized, however, that greater sensitivity in some older individuals cannot be ruled out. 73m2) is contraindicated (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Dual Blockade of the Renin- Angiotensin System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin- Angiotensin System (RAS) with ACEIs, ARBs or aliskiren-containing drugs).
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised November 21, 2025[2]
1 Adverse Reaction Overview Summary of the safety profile The safety and tolerability of telmisartan/amlodipine besylate has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
No additional adverse reactions were identified in clinical trials with the combination telmisartan plus amlodipine compared to the adverse reactions of the monocomponents. Peripheral oedema, a recognized dose dependent adverse reaction of the monocomponent amlodipine, was generally observed at a lower incidence in patients who received the telmisartan/amlodipine combination than in those who received amlodipine alone.
Adverse reactions previously reported with one of the monocomponents (telmisartan or amlodipine) may be potential adverse reactions with telmisartan/amlodipine besylate as well, even if not observed in clinical trials or during the post-marketing period.
Therefore, in addition to the reported adverse reactions during the telmisartan/amlodipine besylate development program all adverse reactions reported in patients who received telmisartan or amlodipine monotherapy, have been listed for telmisartan/amlodipine besylate.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. g. hypotension, orthostatic hypotension, syncope) were rare throughout the double-blind treatment period of a randomized, double- dummy, placebo- controlled 4 x 4 factorial design trial, including the initial 2 weeks of first-line combination therapy.
There were no serious cases. Almost all of the events were of mild or moderate intensity, and the majority of patients continued treatment and recovered without requiring therapy. In a single, randomized double-blind placebo controlled, 8-week factorial design comparing free dose combination telmisartan/amlodipine to monotherapy (telmisartan or amlodipine) and placebo, adverse events (AEs) occurred with similar frequency across the treatment groups, with the highest frequency in the telmisartan 80mg/amlodipine 5 mg (T80/A5) group but the incidence of all AEs, in all groups was within 4% of the placebo group.
Three serious adverse events occurred in the T80/A5 group, none of which were felt to be drug related. The three serious adverse events occurred in 3 different patients and included multiple fractures, deep venous thrombosis, and chest pain (see Table 2).
Table 2:
Summary of adverse events by overall treatment groups in the factorial study. T40/A5 T40/A10 T80/A5 T80/A10 T40 T80 A5 A10 Placebo n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%) Incidence over entire study: No. 0) 1 Marked laboratory abnormalities or AEs leading to intervention, other than those considered serious 2 A patient may be counted in more than one seriousness criterion T = Telmisartan 40 or 80 mg; A = amlodipine 5 or 10 mg.
8%). Patient frequencies of some common AEs were higher in some combination groups than in the respective component monotherapy groups, but no consistent patterns were apparent (see Table 3). e. peripheral edema, headache and fatigue), all drug-related AEs were reported by <1% of patients in any treatment group.
Additional data on long term safety was based on an open-label, limited study, of 6 month up to 8 months duration and no new safety signals were noted.
Table 3:
Adverse events with reported incidence ≥2% […]
CAOfficial regulatory label· Warnings and precautions· revised November 21, 2025[2]
, Cardiovascular, Dual Blockade of the Renin- Angiotensin System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin- Angiotensin System (RAS) with ACEIs, ARBs or aliskiren-containing drugs). • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • Patients with a hypersensitivity to dihydropyridine derivatives. • Patients with a known hypersensitivity (anaphylaxis) or angioedema to ARBs (see 7 WARNINGS AND PRECAUTIONS, General).
1 Pregnant Women) o When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus. When pregnancy is detected, RIVA- TELMISARTAN/AMLODIPINE should be discontinued as soon as possible.
2 Breast-feeding). • Patients with biliary obstructive disorders. • Patients with severe hepatic impairment. Product Monograph RIVA-TELMISARTAN/AMLODIPINE (telmisartan/amlodipine) Page 6 of 54 • Patients with shock including cardiogenic shock.
• Severe hypotension (less than 90 mmHg systolic). g. high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myocardial infarction. • Patients with rare hereditary conditions that may be incompatible with an excipient of the product.
• Patients with the rare hereditary condition of fructose intolerance (HFI) o Mannitol: Mannitol is a source of fructose. 72 mg of mannitol in each tablet respectively. o Meglumine: Meglumine is a source of fructose. 80 mg of meglumine in each tablet respectively.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus. 1 Special Populations). 1 Dosing Considerations Patients should be titrated on individual drugs.
If the fixed dose combination represents the dose and dosing frequency determined by this titration, the use of RIVA-TELMISARTAN/AMLODIPINE may be more convenient in the management of patients. If during maintenance therapy dosage adjustment is necessary, it is advisable to use the individual drugs.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised November 21, 2025[2]
73m2) is contraindicated (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Dual Blockade of the Renin- Angiotensin System (RAS) and Renal, and 9 DRUG INTERACTIONS, Dual Blockade of the Renin- Angiotensin System (RAS) with ACEIs, ARBs or aliskiren-containing drugs).
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
• Patients with a hypersensitivity to dihydropyridine derivatives. • Patients with a known hypersensitivity (anaphylaxis) or angioedema to ARBs (see 7 WARNINGS AND PRECAUTIONS, General). 1 Pregnant Women) o When used in pregnancy, angiotensin receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus.
When pregnancy is detected, RIVA- TELMISARTAN/AMLODIPINE should be discontinued as soon as possible. 2 Breast-feeding). • Patients with biliary obstructive disorders. • Patients with severe hepatic impairment. Product Monograph RIVA-TELMISARTAN/AMLODIPINE (telmisartan/amlodipine) Page 6 of 54 • Patients with shock including cardiogenic shock.
• Severe hypotension (less than 90 mmHg systolic). g. high grade aortic stenosis). • Haemodynamically unstable heart failure after acute myocardial infarction. • Patients with rare hereditary conditions that may be incompatible with an excipient of the product.
• Patients with the rare hereditary condition of fructose intolerance (HFI) o Mannitol: Mannitol is a source of fructose. 72 mg of mannitol in each tablet respectively. o Meglumine: Meglumine is a source of fructose. 80 mg of meglumine in each tablet respectively.
This is not medical advice. Consult a qualified healthcare professional.
Posology The fixed dose combination should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. 5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 40 mg. 5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by telmisartan 80 mg.
Elderly 3 No dose adjustment is necessary for elderly patients. Renal impairment Experience in patients with mild to moderate renal impairment is modest but has not suggested adverse renal effects and dose adjustment is not considered necessary.
4). 3). Telmisartan is not removed from blood by haemofiltration and is not dialysable. Hepatic impairment In patients with mild to moderate hepatic impairment Tolucombi should be administered with caution. For telmisartan, the posology should not exceed telmisartan 40 mg once daily.
3). 4). Paediatric population The safety and efficacy of Tolucombi has not been established in patients aged below 18 years. Use of Tolucombi is not recommended in children and adolescents. Method of administration Tolucombi tablets are for once-daily oral administration and should be swallowed whole with liquid.
Tolucombi can be taken with or without food. Precautions to be taken before handling or administering the medicinal product Tolucombi should be kept in the sealed blister due to the hygroscopic property of the tablets. 6).
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised May 6, 2026[3]
Summary of the safety profile The most commonly reported adverse reaction is dizziness. Serious angioedema may occur rarely (≥ 1/10 000 to < 1/1 000). The overall incidence of adverse reactions reported with telmisartan/hydrochlorothiazide was comparable to those reported with telmisartan alone in randomised controlled trials involving 1 471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients. 05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with telmisartan/hydrochlorothiazide. Adverse reactions previously reported with one of the individual components may be potential adverse reactions with Tolucombi, even if not observed in clinical trials with this product.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Tabulated list of adverse reactions (MedDRA) from placebo-controlled studies and from post-marketing experience 11 MedDRA System Organ Class Adverse Reactions Frequency Telmisartan/ hydrochlorot hiazide Telmisartana Hydrochlorothiazide Infections and infestations Sepsis including fatal outcome rare2 Bronchitis rare Pharyngitis rare Sinusitis rare Upper respiratory tract infection uncommon Urinary tract infection uncommon Cystitis uncommon Neoplasms benign, malignant and unspecified (incl.
4) very rare Gastrointestinal disorders Diarrhoea uncommon uncommon common Dry mouth uncommon rare Flatulence uncommon uncommon Abdominal pain rare uncommon Constipation rare rare Dyspepsia rare uncommon Vomiting rare uncommon common Gastritis rare Abdominal discomfort rare rare Nausea common Pancreatitis very rare Hepatobiliary disorders Abnormal hepatic function/liver disorder rare2 rare2 Jaundice rare 13 Cholestasis rare Skin and subcutaneous tissue disorders Angioedema (including fatal outcome) rare rare Erythema rare rare Pruritus rare uncommon Rash rare uncommon common Hyperhidrosis rare uncommon Urticaria rare rare common Eczema rare Drug eruption rare Toxic skin eruption rare Lupus-like syndrome very rare Photosensitivity reaction rare Toxic epidermal necrolysis very rare Erythema multiforme not known Muscoloskeletal, connective tissue and bone disorders Back pain uncommon uncommon Muscle spasms (cramps in leg) uncommon uncommon not known Myalgia uncommon uncommon Arthralgia rare rare Pain in extremity (leg pain) rare rare Tendon pain (tendonitis-like symptoms) rare Systemic lupus erythematosus rare1 very rare Renal and urinary disorders Renal impairment uncommon not known Acute renal failure uncommon uncommon Glucosuria rare Reproductive system and breast disorders Erectile dysfunction uncommon common General disorders and administration site conditions Chest pain uncommon uncommon Influenza-like illness rare rare Pain rare Asthenia (weakness) uncommon not known Pyrexia not known Investigations Blood uric acid increased uncommon rare Blood creatinine increased rare uncommon Blood creatine phosphokinase increased rare rare 14 Hepatic enzyme increased rare rare Haemoglobin decreased rare 1 Based on post-marketing experience 2 See subsections below for additional information a Adverse reactions occurred with similar frequency in placebo and telmisartan treated patients.
9%) in placebo controlled trials. The adverse reactions listed above have been accumulated from all clinical trials […]
EUOfficial regulatory label· Warnings and precautions· revised May 6, 2026[3]
Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy. Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
6). 3) since telmisartan is mostly eliminated in the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. In addition, telmisartan/hydrochlorothiazide should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
There is no clinical experience with telmisartan/hydrochlorothiazide in patients with hepatic impairment. Renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
3). There is no experience regarding the administration of telmisartan/hydrochlorothiazide in patients with recent kidney transplantation. Experience with telmisartan/hydrochlorothiazide is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function. Telmisartan is not removed from blood by haemofiltration and is not dialysable. Volume and/or sodium depleted patients Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Such conditions, especially volume and/or sodium depletion, should be corrected before the administration of Tolucombi. Isolated cases of hyponatraemia accompanied by neurological symptoms (nausea, progressive disorientation, apathy) have been observed with the use of hydrochlorothiazide.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised May 6, 2026[3]
1. - Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). 6). - Cholestasis and biliary obstructive disorders. - Severe hepatic impairment. - Severe renal impairment (creatinine clearance < 30 mL/min), anuria.
- Refractory hypokalaemia, hypercalcaemia. 1).
This is not medical advice. Consult a qualified healthcare professional.
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.
Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. 1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.
Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic 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. (1) Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy (1)
How to take
USOfficial regulatory label· revised August 20, 2025[4]
5 mg orally once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. 5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Patients titrated to the individual components (telmisartan and hydrochlorothiazide) may instead receive the corresponding dose of telmisartan and hydrochlorothiazide tablets.
Telmisartan and hydrochlorothiazide tablets may be administered with other antihypertensive drugs. 5 mg combination. 3)]. 3 Important Administration Instructions Telmisartan and hydrochlorothiazide tablets should not be removed from blisters until immediately before administration.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,668 reports total. [5]
Fatigue 174
Nausea 146
Headache 145
Asthenia 131
Fall 131
Off Label Use 128
Vomiting 122
Pneumonia 121
Blood Pressure Increased 120
Pain 117
Diarrhoea 113
Malaise 112
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised August 20, 2025[4]
gov/medwatch. 1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction 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 hydrochlorothiazide has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.
Adverse reactions occurring at an incidence of ≥2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies (14)]. 25 to 25 mg), and combinations thereof Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis.
Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients. 4%, respectively, of patients with essential hypertension treated with telmisartan and hydrochlorothiazide tablets in controlled trials.
3)] . 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of telmisartan and hydrochlorothiazide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders:
Eosinophilia Cardiac Disorders: Tachycardia Ear and Labyrinth Disorders: Vertigo General Disorders and Administration Site Conditions: Asthenia, edema Hepato-biliary: Abnormal hepatic function/liver disorder Immune System Disorders: Anaphylactic reaction Investigations: Increased CPK Metabolism and Nutrition Disorders: Hypoglycemia (in diabetic patients), hyponatremia Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis Nervous System Disorders: Headache, syncope Renal and Urinary Disorders: Renal failure, renal impairment including acute renal failure Reproductive System and Breast Disorders: Erectile dysfunction Respiratory, Thoracic and Mediastinal Disorders: Coughing Skin and Subcutaneous Tissue Disorders: Angioedema (with fatal outcome), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria) Vascular Disorder: Orthostatic hypotension Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.
In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.
USOfficial regulatory label· Warnings and precautions· revised August 20, 2025[4]
1) Correct volume or salt depletion before initiating therapy. 1 Fetal Toxicity Telmisartan 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.
Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible.
Hydrochlorothiazide Thiazides cross the placental barrier and appear in cord blood. 1)]. , those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with telmisartan and hydrochlorothiazide.
Correct volume or salt depletion prior to administration of telmisartan and hydrochlorothiazide. 3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics.
, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing oliguria, progressive azotemia, or acute renal failure on telmisartan and hydrochlorothiazide.
Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on telmisartan and hydrochlorothiazide. 4)] . Hydrochlorothiazide can cause hypokalemia and hyponatremia.
Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.
4 mEq/L, and no patient experienced hyperkalemia. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Because telmisartan decreases uric acid, telmisartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricemia.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised August 20, 2025[4]
5)]. In patients with anuria. 4)]. Hypersensitivity to telmisartan or any component (4) Anuria (4) Co-Administration with aliskiren in patients with diabetes (4)
This is not medical advice. Consult a qualified healthcare professional.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Diabetic patients treated with insulin or antidiabetics In these patients hypoglycaemia may occur under telmisartan treatment.
Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated. Hyperkalaemia The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events, hyperkalaemia may be fatal.
Before considering the concomitant use of medicinal products that affect the renin-angiotensin-aldosterone system, the benefit risk ratio should be evaluated. The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin- angiotensin-aldosterone system and/or potassium supplements.
Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
g. g. acute limb ischemia, rhabdomyolysis, extend trauma). 5). Ethnic differences As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
Intestinal angioedema Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists (see […]
2 Recommended Dose and Dosage Adjustment • RIVA-TELMISARTAN/AMLODIPINE should be taken once daily. • If during maintenance therapy dosage adjustment is necessary, it is advisable to use the individual drugs. g. to enhance convenience.
Special populations Renal impairment No dosage adjustment is required for patients with renal impairment, including those on haemodialysis. Product Monograph RIVA-TELMISARTAN/AMLODIPINE (telmisartan/amlodipine) Page 7 of 54 Hepatic impairment In patients with mild to moderate hepatic impairment RIVA-TELMISARTAN/AMLODIPINE should be administered with caution.
For telmisartan the dosage should not exceed 40 mg once daily as hepatic impairment increases bioavailability (see Special Populations and Conditions - Hepatic insufficiency). Amlodipine dosage requirement have not been established in patients with impaired hepatic function.
When amlodipine is used in these patients, it should be initiated at the lower end of the dosing range and the dosage should be carefully and gradually adjusted depending on the patient’s tolerance and response. Geriatrics (> 65 years of age) No dose adjustment is necessary for elderly patients.
It should be recognized, however, that greater sensitivity in some older individuals cannot be ruled out. If required, increase in the dose should be done gradually and with caution (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Pediatric population (<18 years of age) RIVA-TELMISARTAN/AMLODIPINE is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy. Drug discontinuation If laryngeal stridor or angioedema of the face, extremities, lips, tongue, or glottis occurs, RIVA- TELMISARTAN/AMLODIPINE should be discontinued immediately, the patient treated appropriately in accordance with accepted medical care, and carefully observed until the swelling disappears.
When pregnancy is detected, RIVA-TELMISARTAN/AMLODIPINE should be discontinued as soon as possible. 4 Administration Tablet for oral administration RIVA-TELMISARTAN/AMLODIPINE should be taken consistently with or without food. RIVA- TELMISARTAN/AMLODIPINE tablets are for once-daily oral administration and should be swallowed whole with liquid.
5 Missed Dose If a dose is missed during the day, the next dose should be continued at the usual time. Do not double dose. 5 OVERDOSAGE Symptoms Telmisartan/amlodipine tablets: Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects.
Telmisartan:
Limited data are available with regard to telmisartan overdosage in humans. The most prominent manifestations of overdosage were hypotension and/or tachycardia; bradycardia also occurred. Product Monograph RIVA-TELMISARTAN/AMLODIPINE (telmisartan/amlodipine) Page 8 of 54 It is not known if telmisartan can be removed from the body by hemodialysis.
Amlodipine:
Overdose with amlodipine may result in excessive peripheral vasodilatation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and […]
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
g. 8). Primary aldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of telmisartan/hydrochlorothiazide is not recommended.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral 5 stenosis, or obstructive hypertrophic cardiomyopathy. Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance, whereas hypoglycaemia may occur in diabetic patients under insulin or antidiabetic therapy and telmisartan treatment.
Therefore, in these patients blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated. Latent diabetes mellitus may become manifest during thiazide therapy. 5 mg dose contained in the medicinal product, minimal or no effects were reported.
Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy. Electrolyte imbalance As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and hypochloraemic alkalosis). 8). - Hypokalaemia Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic-induced hypokalaemia.
The risk of hypokalaemia is greater in […]
5 Hypersensitivity Reaction Hydrochlorothiazide Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history [see Contraindications (4)].
6 Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. 7 Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
8 Postsympathectomy Patients The antihypertensive effects of hydrochlorothiazide may be enhanced in the postsympathectomy patient.