Brand name · Vutrisiran
Amvuttra: adverse event reports filed with FDA
2,469 reports list it as a suspect or interacting product, 2019–2026. Class: Small interfering RNA.
- 2,469
- reports as suspect product
- 0% of all reports · about 345 a year
- 1,249
- reports, 12 months to June 2026
- 581 in the 12 months before
- 84.4%
- marked serious by the reporter
- 75.2% across the class
- 25.6%
- record death among outcomes, as reported
- 631 reports · not verified by FDA
Between May 2019 and June 2026, 2,469 adverse event reports received by FDA list the brand name Amvuttra (vutrisiran) as a suspect or interacting product. Reports that mention it only as a concomitant medication (54) are left out of every figure here.
In the 12 months to June 2026, 1,249 reports listed it, up 115% from 581 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 345 reports a year and 0% of the 20,646,523 reports in the database, and 47.5% of the reports for the small interfering RNA class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are death (20.2%), hospitalisation (12.6%) and intentional dose omission (8.1%). A report can list several reactions, so shares add to more than 100%; 408 different terms appear across these reports. Death is recorded in 20.2% of these reports, a larger share than in the median small interfering RNA drug (14.9%).
84.4% of the reports are marked serious by the reporter (75.2% across the class); 25.6% record death among the outcomes and 40.3% record hospitalisation, as reported. 60.7% of the reports came from consumers, and the largest patient age group is 75 and over (14.4%). 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 Amvuttra reports recording the termmedian drug in small interfering rna
- Deaththe patient died; cause not stated by this term20.2%499
- Hospitalisationadmission to hospital12.6%310
- Intentional dose omission8.1%200
- Product dose omission issuea dose was missed5.3%131
- Falla fall4.6%114
- Fatiguetiredness3.5%87
- Therapy interrupted3.4%84
- Dyspnoeashortness of breath3.2%78
- Cardiac failureheart failure3.1%77
- Gait disturbancedifficulty walking3%74
- Pain in extremitypain in an arm or leg2.7%66
- Astheniaweakness or lack of energy2.6%64
- Arthralgiajoint pain2.6%63
- Atrial fibrillationan irregular heart rhythm2.5%61
- Painpain, site not specified2.3%56
- Pneumonialung infection2.3%56
- Unevaluable eventthe event could not be assessed2.1%53
- Ill-defined disordera condition that was not clearly described2.1%51
- Malaisegeneral feeling of being unwell2.1%51
- Cerebrovascular accidentstroke1.9%48
- Neuropathy peripheralnerve damage in hands or feet1.9%48
- Dizzinesslight-headedness or unsteadiness1.9%46
- Peripheral swellingswelling of the arms or legs1.9%46
- Cardiac disorder1.7%42
- Condition aggravatedthe condition being treated got worse1.6%40
- Diarrhoealoose or frequent stools1.6%40
- Drug ineffectivethe medicine did not work as expected1.6%39
- Hypoaesthesianumbness1.6%39
- Balance disorderproblems with balance1.4%35
- General physical health deteriorationgeneral decline in health1.4%35
Top 30 of 408 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 small interfering rna 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 5,193 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. 79.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hereditary neuropathic amyloidosis | 1,330 | 53.9% |
| Acquired attr amyloidosis | 368 | 14.9% |
| Cardiac amyloidosis | 209 | 8.5% |
| Amyloidosis | 32 | 1.3% |
| Familial amyloidosis | 5 | 0.2% |
| Hereditary attr amyloid cardiomyopathy | 4 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,469 reports.
In context
| Measure | Amvuttra | Small interfering RNA | All reports |
|---|---|---|---|
| Reports as suspect product | 2,469 | 5,193 | 20,646,523 |
| Share of that pool | — | 47.5% | 0% |
| Reports, latest 12 months | 1,249 | — | 1,332,454 |
| Marked serious | 84.4% | 75.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 256 | 200 | 91 |
| Hospitalisation recorded, per 1,000 reports | 403 | 391 | 213 |
| Consumer-filed share | 60.7% | 50.3% | 45.8% |
| Top term, share of reports | Death 20.2% | median 14.9% | 4.1% |
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 small interfering rna class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Onpattro | brand | 2,724 | 110 | 66.8% |
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 Amvuttra reports
How many adverse event reports has FDA received for Amvuttra?
2,469 reports list Amvuttra as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,249 of them arrived in the latest 12 months. Another 54 list it only as a concomitant medication.
What reactions are recorded in Amvuttra reports?
death (20.2%), hospitalisation (12.6%), intentional dose omission (8.1%), product dose omission issue (5.3%) and fall (4.6%). 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 Amvuttra was responsible.
How serious are the reports?
84.4% are marked serious by the reporter. Among the outcomes recorded, 25.6% of reports include death and 40.3% 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?
consumer or non-health professional (60.7%), other health professional (19.9%) and physician (18.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Amvuttra rising?
1,249 reports in the 12 months to June 2026, up 115% from 581 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 Amvuttra 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 Amvuttra?
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 Amvuttra as a suspect or interacting product; reports listing it only as a concomitant medication (54) 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.