What the label lists and what reports show
Sparsentan side effects
Sparsentan's FDA label: “Most common adverse reactions in patients with IgAN (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury ( 6.1 ).” FAERS holds 5,866 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (837 reports).
- No generic listed
- Boxed warning
Check it at the source: the sparsentan FDA label on DailyMed (effective April 9, 2026, Travere Therapeutics, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FILSPARI?FILSPARI can cause serious side effects, including: • Liver Problems. See “ What is the most important information I should know about FILSPARI? ” • Serious birth defects. See “ What is the most important information I should know about FILSPARI? ” • Low blood pressure. Low blood pressure is common during treatment with FILSPARI and can also be serious. Tell your healthcare provider if you feel dizzy, light-headed, or faint. Stay hydrated during treatment with FILSPARI. • Worsening of kidney function. This is common during treatment with FILSPARI and can also be serious. Your healthcare provider will check your kidney function during treatment with FILSPARI. • Increased potassium in your blood. This is common during treatment with FILSPARI and can also be serious. Your healthcare provider will check your potassium blood level during treatment with FILSPARI. • Fluid retention. […]
Source: FDA drug label, Travere Therapeutics, Inc., effective April 9, 2026 (SPL set d7354af1-f304-f4d9-e053-2995a90ab219), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in patients with IgAN (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury ( 6.1 ).
Table 3: Adverse Reactions Reported in 2% or More of Subjects with IgAN Treated with FILSPARI (PROTECT)
| Reaction | FILSPARI (N = 202) n (%) | Irbesartan (N = 202) n (%) |
|---|---|---|
| Hyperkalemia 1 | 34 (17) | 27 (13) |
| Hypotension (including orthostatic hypotension) | 33 (16) | 13 (6) |
| Peripheral edema 1 | 33 (16) | 29 (14) |
| Dizziness 1 | 32 (16) | 14 (7) |
| Anemia | 16 (8) | 9 (4) |
| Acute kidney injury | 12 (6) | 5 (2) |
| Transaminase elevations 2 | 7 (3.5) | 8 (4.0) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedClinically significant adverse reactions that appear in other sections of the label include: • Hepatotoxicity [see Warnings and Precautions ( 5.1 )] • Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.3 )] • Hypotension [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury [see Warnings and Precautions ( 5.5 )] • Hyperkalemia [see Warnings and Precautions ( 5.6 )] • Fluid Retention [see Warnings and Precautions ( 5.7 )] Most common adverse reactions in patients with IgAN (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury ( 6.1 ). Most common adverse reactions in patients with FSGS (≥5%) are peripheral edema, hypotension (including orthostatic hypotension), hyperkalemia, dizziness, and anemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Travere Therapeutics at 1-877-659-5518 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. IgAN The safety of FILSPARI was evaluated in PROTECT ( NCT03762850 ), a randomized, double-blind, active-controlled clinical study in adults with IgAN. …
Source: FDA drug label, Travere Therapeutics, Inc., effective April 9, 2026 (SPL set d7354af1-f304-f4d9-e053-2995a90ab219), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,866 reports list sparsentan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 32 are coded as a death and 405 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,395, against a median of 2 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sparsentan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions