Pharmacologic class (EPC) · 2 drug pages

Survival of motor neuron 2 splicing modifier: adverse event reports filed with FDA

3,965 reports list a drug in this class as a suspect or interacting product, 2020–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,965
reports across the class: 0% of all reports; 444
reports, 12 months to June 2026: 1,288 in the 12 months before; 44.6%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Survival of motor neuron 2 splicing modifier is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 3,965 adverse event reports received by FDA, 0% of the database, from September 2020 to June 2026.

444 reports arrived in the 12 months to June 2026, down 66% from 1,288 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 44.6% of the class's reports are marked serious, 10.4% record death among the outcomes and 20.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are no adverse event (8.7%), diarrhoea (7.4%) and asthenia (5.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
EvrysdiRisdiplam	brand	3,403	367	39.8%	No adverse event
Risdiplam	generic	562	77	73.7%	Death

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

No adverse eventno adverse event was reported8.7%344
Diarrhoealoose or frequent stools7.4%292
Astheniaweakness or lack of energy5.5%220
Pneumonialung infection5.3%211
Deaththe patient died; cause not stated by this term5%200
Pyrexiafever4.2%166
Fatiguetiredness3.8%150
Muscular weaknessmuscle weakness3.4%135
Vomitingbeing sick3.2%126
Drug ineffectivethe medicine did not work as expected3.1%124
Covid-19COVID-19 infection2.6%105
Headachehead pain2.6%102
Rashskin rash2.5%101
Product dose omission issuea dose was missed2.4%94
Nauseafeeling sick2.3%92
Gastrointestinal disorder2.1%85
Weight increasedweight gain2.1%83
Off label useused for a purpose or in a way not on the label2.1%82
Constipationconstipation2%80
Nasopharyngitisa cold2%78
Weight decreasedweight loss1.9%75
Respiratory tract infectiona respiratory infection1.8%72
Urinary tract infectionbladder or urinary infection1.8%71
Dyspnoeashortness of breath1.7%68
Influenzaflu1.6%63

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.4%413

Life-threatening1.7%68

Hospitalisation (initial or prolonged)20.6%816

Disability2.2%88

Congenital anomaly0.2%9

Other serious17%674

Not serious55.4%2,197

Patient age

Under 27.4%293

2 to 1114.9%589

12 to 176.5%258

18 to 4420.3%803

45 to 647.4%295

65 to 741.5%59

75 and over0.5%18

Age not given41.6%1,650

Who reported

Physician28.3%1,122

Pharmacist3.6%144

Other health professional9%355

Lawyer0%0

Consumer or non-health professional59%2,338

Not given0.2%6

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Survival of motor neuron 2 splicing modifier reports

Which drugs are in the Survival of motor neuron 2 splicing modifier class on this site?

Evrysdi and Risdiplam. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

3,965 reports through June 2026, 444 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

no adverse event (8.7%), diarrhoea (7.4%), asthenia (5.5%), pneumonia (5.3%) and death (5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.