85/100 · Critical
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
Telmisartan Adverse Events: High Serious Reaction Rate
72,751 FDA adverse event reports analyzed
Last updated: 2026-05-12
TELMISARTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of 72,751 FDA adverse event reports, TELMISARTAN has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TELMISARTAN include NAUSEA, FATIGUE, DRUG INEFFECTIVE, DIARRHOEA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TELMISARTAN.
Telmisartan has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 72,751 adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
The most commonly reported adverse events include Nausea, Fatigue, Drug Ineffective. Of classified reports, 82.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea, fatigue, and dizziness are the most common adverse events reported.
Serious reactions, such as pneumonia, acute kidney injury, and sepsis, are frequent. Drug interactions and off-label use are reported, warranting caution.
Patients taking Telmisartan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Telmisartan can interact with other drugs, and its use in unapproved indications is noted. Close monitoring is advised. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Telmisartan received a safety concern score of 85/100 (high concern). This is based on a 82.9% serious event ratio across 33,605 classified reports. The score accounts for 72,751 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 17,157, Male: 13,711, Unknown: 45. The most frequently reported age groups are age 65 (825 reports), age 75 (792 reports), age 68 (737 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 33,605 classified reports for TELMISARTAN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Telmisartan can interact with other drugs, and its use in unapproved indications is noted. Close monitoring is advised.
If you are taking Telmisartan, here are important things to know. The most commonly reported side effects include nausea, fatigue, drug ineffective, diarrhoea, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of serious adverse events, especially respiratory and cardiovascular issues. Be cautious when using telmisartan in unapproved indications. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions.
The FDA has received approximately 72,751 adverse event reports associated with Telmisartan. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Telmisartan include Nausea, Fatigue, Drug Ineffective, Diarrhoea, Dyspnoea. By volume, the top reported reactions are: Nausea (2,058 reports), Fatigue (2,001 reports), Drug Ineffective (1,884 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Telmisartan.
Out of 33,605 classified reports, 27,867 (82.9%) were classified as serious and 5,738 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Telmisartan break down by patient sex as follows: Female: 17,157, Male: 13,711, Unknown: 45. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Telmisartan adverse events are: age 65: 825 reports, age 75: 792 reports, age 68: 737 reports, age 69: 732 reports, age 73: 719 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Telmisartan adverse event reports is Boehringer Ingelheim Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Telmisartan include: Headache, Dizziness, Fall, Blood Pressure Increased, Hypertension. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Telmisartan to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Telmisartan has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Nausea, fatigue, and dizziness are the most common adverse events reported.
Key safety signals identified in Telmisartan's adverse event data include: High frequency of serious reactions (82.9%). Multiple cardiovascular and renal adverse events reported. Significant number of reports involving respiratory issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Telmisartan can interact with other drugs, and its use in unapproved indications is noted. Close monitoring is advised. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Telmisartan.
Monitor patients for signs of serious adverse events, especially respiratory and cardiovascular issues. Be cautious when using telmisartan in unapproved indications.
Telmisartan has 72,751 adverse event reports on file with the FDA. Serious reactions, such as pneumonia, acute kidney injury, and sepsis, are frequent. The volume of reports for Telmisartan reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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