Generic name
Aliskiren hemifumarate: adverse event reports filed with FDA
244 reports list it as a suspect or interacting product, 2013–2026. Class: Renin inhibitor.
- 244
- reports as suspect product
- 0% of all reports · about 19 a year
- 54
- reports, 12 months to June 2026
- 86 in the 12 months before
- 99.2%
- marked serious by the reporter
- 74.7% across the class
- 17.6%
- record death among outcomes, as reported
- 43 reports · not verified by FDA
244 adverse event reports received by FDA list aliskiren hemifumarate, a generic name as a suspect or interacting product, from September 2013 to June 2026. A further 39 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 54 reports listed it, down 37% from 86 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 19 reports a year and 0% of the 20,646,523 reports in the database, and 5.9% of the reports for the renin inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are fall (85.7%), nausea (85.7%) and fatigue (77.9%). A report can list several reactions, so shares add to more than 100%; 110 different terms appear across these reports. Fall is recorded in 85.7% of these reports, a larger share than in the median renin inhibitor drug (10.2%).
99.2% of the reports are marked serious by the reporter (74.7% across the class); 17.6% record death among the outcomes and 77.5% record hospitalisation, as reported. 79.5% of the reports came from other health professionals, and the largest patient age group is 65 to 74 (45.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Aliskiren hemifumarate reports recording the termmedian drug in renin inhibitor
- Falla fall85.7%209
- Nauseafeeling sick85.7%209
- Fatiguetiredness77.9%190
- Malaisegeneral feeling of being unwell68.9%168
- Motor dysfunction68.9%168
- Muscle spasticity68.9%168
- Neurologic neglect syndrome68.9%168
- Personality disorder68.9%168
- Sensory loss68.9%168
- Hemiparesis68.4%167
- Hemiplegia68.4%167
- Muscular weaknessmuscle weakness68.4%167
- Pyrexiafever68.4%167
- Vomitingbeing sick68.4%167
- Dysphagiadifficulty swallowing68%166
- Eating disorder68%166
- Headachehead pain68%166
- Affect lability67.6%165
- Anxietyanxiety67.6%165
- Aphasiadifficulty with language67.6%165
- Carotid artery thrombosis67.6%165
- Cerebrovascular accidentstroke67.6%165
- Confusional stateconfusion67.6%165
- Coordination abnormal67.6%165
- Dysarthria67.6%165
- Adjustment disorder65.6%160
- Blood pressure increaseda raised blood pressure reading63.9%156
- Coughcough63.9%156
- Influenzaflu61.5%150
- Influenza like illnessflu-like symptoms61.5%150
Top 30 of 110 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the renin inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 4,115 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 1.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Off label use | 63 | 25.8% |
| Microalbuminuria | 50 | 20.5% |
| Hypertension | 38 | 15.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 244 reports.
In context
| Measure | Aliskiren hemifumarate | Renin inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 244 | 4,115 | 20,646,523 |
| Share of that pool | — | 5.9% | 0% |
| Reports, latest 12 months | 54 | — | 1,332,454 |
| Marked serious | 99.2% | 74.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 176 | 141 | 91 |
| Hospitalisation recorded, per 1,000 reports | 775 | 308 | 213 |
| Consumer-filed share | 8.6% | 28.9% | 45.8% |
| Top term, share of reports | Fall 85.7% | median 10.2% | 1.6% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the renin inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Tekturna | brand | 2,257 | 18 | 56.1% |
| Aliskiren | generic | 1,858 | 53 | 97.4% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Aliskiren hemifumarate reports
How many adverse event reports has FDA received for Aliskiren hemifumarate?
244 reports list Aliskiren hemifumarate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 54 of them arrived in the latest 12 months. Another 39 list it only as a concomitant medication.
What reactions are recorded in Aliskiren hemifumarate reports?
fall (85.7%), nausea (85.7%), fatigue (77.9%), malaise (68.9%) and motor dysfunction (68.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Aliskiren hemifumarate was responsible.
How serious are the reports?
99.2% are marked serious by the reporter. Among the outcomes recorded, 17.6% of reports include death and 77.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (79.5%), physician (11.9%) and consumer or non-health professional (8.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Aliskiren hemifumarate rising?
54 reports in the 12 months to June 2026, down 37% from 86 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Aliskiren hemifumarate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Aliskiren hemifumarate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Aliskiren hemifumarate as a suspect or interacting product; reports listing it only as a concomitant medication (39) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.