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telmisartan Side Effects

Also known as: Micardis

Analysis of 33,611 adverse event reports submitted to the FDA from 2001 to 2025.

Total Reports

33,611

Death-Related

3,166

9.4% of reports

Hospitalizations

14,967

44.5% of reports

Top Indication

Hypertension

Most Reported Adverse Reactions

NAUSEA
2,059
FATIGUE
2,001
DRUG INEFFECTIVE
1,884
DIARRHOEA
1,794
DYSPNOEA
1,785
HEADACHE
1,715
DIZZINESS
1,682
FALL
1,594
BLOOD PRESSURE INCREASED
1,510
HYPERTENSION
1,460
ARTHRALGIA
1,428
MALAISE
1,424
ASTHENIA
1,408
OFF LABEL USE
1,396
VOMITING
1,353
PAIN
1,310
COUGH
1,234
PNEUMONIA
1,185
PYREXIA
1,180
PRURITUS
1,050

Who Reports Side Effects

Gender Distribution

Female 17,155 (56%)
Male 13,709 (44%)
Unknown 45

Age Distribution

0-17 293 (1%)
18-44 1,118 (5%)
45-64 7,409 (31%)
65-74 6,954 (29%)
75+ 7,961 (34%)

Reporting Trend by Year

2001 2025

Reactions in Death Reports

Top reactions reported in 3,166 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 660
SEPSIS 360
DIARRHOEA 340
DYSPNOEA 326
FALL 315
CARDIO-RESPIRATORY ARREST 312
DECREASED APPETITE 283
HAEMORRHAGIC STROKE 276
DIZZINESS 275
FATIGUE 268
ASTHENIA 267
HEADACHE 266
ALTERED STATE OF CONSCIOUSNESS 263
ASCITES 258
TACHYCARDIA 258
NAUSEA 255
ARTHRALGIA 254
PYREXIA 251
HAEMATEMESIS 249
PNEUMONIA 249

Reactions in Hospitalization Reports

Top reactions in 14,967 reports where hospitalization was an outcome.

Reaction Reports
FALL 1,015
PNEUMONIA 906
NAUSEA 892
DYSPNOEA 784
FATIGUE 777
VOMITING 774
PYREXIA 743
DIARRHOEA 700
MALAISE 684
ACUTE KIDNEY INJURY 678
ASTHENIA 663
PAIN 651
HYPOTENSION 641
HYPERTENSION 634
HEADACHE 609
OFF LABEL USE 587
BLOOD PRESSURE INCREASED 571
DRUG INEFFECTIVE 560
ANAEMIA 533
DIZZINESS 505

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What the FAERS Data Reveals About telmisartan Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 33,611 voluntary reports linked to telmisartan and its brand equivalents (Micardis), spanning 2001 through 2025. Of those, 3,166 (9.4%) listed death as an outcome and 14,967 (44.5%) involved hospitalization. The most common indication reported alongside adverse events was Hypertension.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 56% were female and 44% male; age distribution skews toward 75+, with 7,961 reports in that bracket. The single most reported reaction is nausea with 2,059 submissions, followed by fatigue and drug ineffective.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.