What the label lists and what reports show
Maribavir side effects
Maribavir's FDA label: “The most common adverse events (all grades, >10%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue.” FAERS holds 2,410 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 dysgeusia (265 reports).
- No generic listed
Check it at the source: the maribavir FDA label on DailyMed (effective January 27, 2026, Takeda Pharmaceuticals America, 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 LIVTENCITY?The most common side effects of LIVTENCITY include: changes in taste nausea diarrhea vomiting tiredness These are not all the possible side effects of LIVTENCITY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective January 27, 2026 (SPL set c94fc2c5-e840-4f18-b7d8-d5eacb26d3a0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse events (all grades, >10%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue.
Table 2: Adverse Events (All Grades) Reported in >10% of Subjects in the LIVTENCITY Group in Trial 303
| ADVERSE EVENT | LIVTENCITY N=234 (%) | IAT IAT (Investigator-Assigned Treatment) included monotherapy or dual therapy with… |
|---|---|---|
| Taste disturbance taste disturbance includes the following reported preferred terms:… | 46 | 4 |
| Nausea | 21 | 22 |
| Diarrhea | 19 | 21 |
| Vomiting | 14 | 16 |
| Fatigue | 12 | 9 |
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, continuedThe most common adverse events (all grades, >10%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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. The safety of LIVTENCITY was evaluated in one Phase 3 multicenter, randomized, open-label, active-control trial in which 352 adult transplant recipients were randomized, and treated with LIVTENCITY (N=234) or Investigator-Assigned Treatment (IAT) consisting of monotherapy or dual therapy with ganciclovir, valganciclovir, foscarnet, or cidofovir as dosed by the investigator (N=116) for up to 8-weeks following a diagnosis of CMV infection/disease refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, foscarnet or cidofovir. The mean treatment durations (SD) for LIVTENCITY and IAT were 48.6 (± 13.82) and 31.2 (± 16.91) days, respectively. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective January 27, 2026 (SPL set c94fc2c5-e840-4f18-b7d8-d5eacb26d3a0), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,410 reports list maribavir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 526 are coded as a death and 1,102 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. Of the 18 reactions below, 6 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?
- Maribavir: 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