OpenClaim

Tofersen Side Effects

The most commonly reported side effects of tofersen include headache, amyotrophic lateral sclerosis, and procedural pain, based on 410 FDA adverse event reports from 2021 to 2025.

Tofersen side effects

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

1
Headache10.5%43
2
Amyotrophic Lateral Sclerosis10.5%43
3
Procedural Pain10.5%43
4
Post Lumbar Puncture Syndrome8.3%34
5
Death7.6%31
6
Back Pain4.9%20
7
Fatigue4.6%19
8
Csf Protein Increased4.6%19
9
Fall4.1%17
10
Pain In Extremity3.9%16
11
Dyspnoea3.7%15
12
Respiratory Failure3.4%14
13
Pain3.4%14
14
Muscular Weakness3.4%14
15
Asthenia2.9%12

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

Report severity

50.0%Serious205 reports
26.3%Hospitalizations108 reports
17.8%Fatal73 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tofersen drug interactions

Other drugs that appear in adverse event reports alongside tofersen. 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
Isavuconazonium-sulfate0.2%1
2
Acetaminophen0.2%1
3
Ceftazidime0.2%1
4
Tramadol-hydrochloride0.2%1
5
Vancomycin0.2%1
6
Dalfampridine0.2%1
7
Riluzole0.2%1
8
Sodium-phenylbutyrate0.2%1
9
Taurursodiol0.2%1
10
Vilazodone-hydrochloride0.2%1
11
Tirzepatide0.2%1
12
Vibegron0.2%1

Taken alongside

1
Riluzole16.1%66
2
Edaravone3.2%13
3
Cyanocobalamin2.2%9
4
Gabapentin2.2%9
5
Aspirin2.0%8
6
Duloxetine-hydrochloride2.0%8
7
Pregabalin2.0%8
8
Acetaminophen2.0%8
9
Sodium-phenylbutyrate1.7%7
10
Baclofen1.7%7
11
Metformin1.7%7
12
Vitamin-e1.7%7
13
Amitriptyline-hydrochloride1.5%6
14
Alprazolam1.5%6
15
Taurursodiol1.5%6

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 tofersen side effects

42.9% of tofersen adverse event reports involve female patients and 47.6% involve male patients. The largest age group is adult at 71%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.9%
Male47.6%
Unknown9.5%

Age group

< 20.4%
2–110.0%
12–170.0%
18–6471.5%
65+28.1%

What is tofersen used for

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

Amyotrophic Lateral SclerosisFamilial Amyotrophic Lateral SclerosisProduct Used For Unknown IndicationProduct Used For Unknown Indication

Tofersen brand names and reporting trend

Tofersen is sold under the brand name Qalsody.

Brand names

Qalsody135

Quarterly reports (20212025)

202120242025

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

Taking tofersen with another medication?

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