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Aliskiren Side Effects

The most commonly reported side effects of aliskiren include nausea, fall, and asthenia, based on 6,789 FDA adverse event reports from 2007 to 2025.

Aliskiren side effects

Percentages show how often each reaction appears relative to total reports for aliskiren.

1
Nausea7.9%536
2
Fall7.9%535
3
Asthenia7.2%486
4
Fatigue6.9%471
5
Headache6.8%462
6
Malaise6.4%433
7
Blood Pressure Increased6.3%426
8
Cough6.2%424
9
Vomiting6.0%408
10
Pyrexia5.4%370
11
Dyspnoea5.4%366
12
Cerebrovascular Accident5.2%350
13
Dizziness4.9%331
14
Diarrhoea4.8%323
15
Anxiety4.4%299

These are voluntary reports and do not establish that aliskiren caused these reactions.

Report severity

71.4%Serious4,847 reports
31.2%Hospitalizations2,117 reports
11.3%Fatal769 reports

Seriousness is determined by the reporter, not by OpenClaim.

Aliskiren drug interactions

Other drugs that appear in adverse event reports alongside aliskiren. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Hydrochlorothiazide14.1%957
2
Aspirin10.8%734
3
Amlodipine9.4%637
4
Valsartan9.3%633
5
Atorvastatin-calcium8.5%579
6
Bisoprolol-fumarate7.5%508
7
Simvastatin7.0%478
8
Omeprazole6.9%466
9
Acetaminophen6.8%460
10
Metformin6.2%422
11
Ezetimibe5.7%389
12
Adalimumab5.3%362
13
Enoxaparin-sodium5.0%342
14
Sitagliptin4.9%335
15
Tramadol-hydrochloride4.9%335

Taken alongside

1
Aspirin17.0%1,151
2
Amlodipine15.1%1,023
3
Hydrochlorothiazide12.6%855
4
Furosemide11.8%804
5
Levothyroxine-sodium10.5%712
6
Metformin10.0%677
7
Acetaminophen9.6%651
8
Insulin8.5%578
9
Metoprolol7.8%529
10
Valsartan7.6%516
11
Simvastatin7.5%512
12
Ergocalciferol7.5%507
13
Atorvastatin-calcium7.0%473
14
Carvedilol6.5%441
15
Rosuvastatin6.5%440

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports aliskiren side effects

52.2% of aliskiren adverse event reports involve female patients and 34.4% involve male patients. The largest age group is elderly at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female52.2%
Male34.4%
Unknown13.3%

Age group

< 22.3%
2–110.3%
12–17<0.1%
18–6437.1%
65+60.2%

What is aliskiren used for

Conditions and purposes for which patients were taking aliskiren when the adverse event was reported.

Acute Myocardial InfarctionAlbuminuriaAlport's SyndromeAlport^s SyndromeAtrial FibrillationAtrioventricular BlockBlood Cholesterol IncreasedBlood PressureBlood Pressure AbnormalBlood Pressure HighBlood Pressure Inadequately ControlledBlood Pressure IncreasedBlood Pressure ManagementBlood Pressure MeasurementBlood Pressure Abnormal

Showing 15 of 79 indications

Aliskiren brand names and reporting trend

Aliskiren is sold under the brand name Tekamlo.

Brand names

Tekamlo3,879

Quarterly reports (20072025)

20072010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking aliskiren with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.