Drug side effects
aliskiren Side Effects
The reactions most often reported to the FDA for aliskiren (also sold as Tekturna), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 2,229
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2007 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of aliskiren come from 2,229 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 2,229 reports to the FDA Adverse Event Reporting System (FAERS) for aliskiren (Tekturna): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
2,229
Reports Mentioning Death
558
25.0% of reports — not proof the medicine caused the death
Hospitalizations
1,137
51.0% of reports
Top Indication
Hypertension
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 558 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 201 |
| HAEMORRHAGIC STROKE | 200 |
| TACHYCARDIA | 200 |
| CARDIO-RESPIRATORY ARREST | 194 |
| FALL | 193 |
| SEPSIS | 193 |
| ALTERED STATE OF CONSCIOUSNESS | 186 |
| DIARRHOEA | 186 |
| OCULAR DISCOMFORT | 185 |
| PRURITUS | 184 |
| AMAUROSIS FUGAX | 183 |
| HAEMATEMESIS | 183 |
| ASTHENIA | 182 |
| CHILLS | 182 |
| COUGH | 182 |
| DECREASED APPETITE | 182 |
| EYE PAIN | 181 |
| HEAD DISCOMFORT | 181 |
| SOMNOLENCE | 181 |
| ARTHRALGIA | 180 |
Reactions in Hospitalization Reports
Top reactions in 1,137 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ASTHENIA | 177 |
| CEREBROVASCULAR ACCIDENT | 171 |
| NAUSEA | 167 |
| FALL | 163 |
| CONFUSIONAL STATE | 150 |
| DYSARTHRIA | 149 |
| ANXIETY | 144 |
| APHASIA | 143 |
| HEMIPARESIS | 143 |
| SENSORY LOSS | 143 |
| MUSCULAR WEAKNESS | 142 |
| COORDINATION ABNORMAL | 140 |
| AFFECT LABILITY | 139 |
| CAROTID ARTERY THROMBOSIS | 139 |
| HEMIPLEGIA | 138 |
| MOTOR DYSFUNCTION | 138 |
| MUSCLE SPASTICITY | 138 |
| NEUROLOGIC NEGLECT SYNDROME | 138 |
| PERSONALITY DISORDER | 138 |
| ADJUSTMENT DISORDER | 136 |
Nearby, Related Medications
What the FAERS Data Reveals About aliskiren Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,229 voluntary reports linked to aliskiren and its brand equivalents (Tekturna), spanning 2007 through 2025. Of those, 558 (25.0%) listed death as an outcome and 1,137 (51.0%) 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, 51% were female and 48% male; age distribution skews toward 45-64, with 434 reports in that bracket. The single most reported reaction is asthenia with 367 submissions, followed by fall and nausea.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to aliskiren's 2,229.
Read our methodology - how this data is sourced, computed, and verified.