What the label lists and what reports show
Sacituzumab govitecan side effects
Sacituzumab govitecan's FDA label: “The most common adverse reactions including laboratory abnormalities: TRODELVY as a single agent (incidence ≥ 25%) were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, nausea, diarrhea, decreased lymphocyte count, fatigue …” FAERS holds 4,518 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 diarrhoea (561 reports).
- No generic listed
- Boxed warning
Check it at the source: the sacituzumab govitecan FDA label on DailyMed (effective June 24, 2026); 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 TRODELVY?TRODELVY can cause serious side effects, including: See “ What is the most important information I should know about TRODELVY? ” Allergic and infusion-related reactions. TRODELVY can cause serious or life-threatening allergic and infusion-related reactions. These reactions are more common within 24 hours of receiving TRODELVY. Tell your healthcare provider right away if you get any of the following symptoms of an allergic or infusion-related reaction during or at any time after your TRODELVY infusion: swelling of your face, lips, tongue, or throat hives skin rash, itching, or flushing of your skin fever difficulty breathing or wheezing lightheadedness, dizziness, feeling faint or passing out chills or shaking chills (rigors) chest pain Nausea and vomiting. Nausea and vomiting can be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting. […]
Source: FDA drug label, Gilead Sciences, Inc., effective June 24, 2026 (SPL set 57a597d2-03f0-472e-b148-016d7169169d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions including laboratory abnormalities: TRODELVY as a single agent (incidence ≥ 25%) were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, nausea, diarrhea, decreased lymphocyte count, fatigue, alopecia, increased glucose, constipation, vomiting, decreased albumin, increased alkaline phosphatase, decreased appetite, abdominal pain, decreased creatinine clearance, decreased magnesium, and decreased potassium.
Table 9: Adverse Reactions in ≥ 10% of Patients with Metastatic TNBC in IMMU-132-01
| Reaction | Adverse Reaction All Grades (%) | TRODELVY (n=108) Grade 3-4 (%) |
|---|---|---|
| Any adverse reaction | 100 | 71 |
| Gastrointestinal disorders | 95 | 21 |
| Nausea | 69 | 6 |
| Diarrhea | 63 | 9 |
| Vomiting | 49 | 6 |
| Constipation | 34 | 0.9 |
| Abdominal pain Includes other related terms | 26 | 0.9 |
| Mucositis | 14 | 0.9 |
| General disorders and administration site conditions | 77 | 9 |
| Fatigue | 57 | 8 |
| Edema | 19 | 0 |
| Pyrexia | 14 | 0 |
| Metabolism and nutrition disorders | 68 | 22 |
| Decreased appetite | 30 | 0.9 |
| Dehydration | 13 | 5 |
| Skin and subcutaneous tissue disorders | 63 | 3.7 |
| Alopecia | 38 | 0 |
| Rash | 31 | 2.8 |
| Pruritus | 17 | 0 |
| Dry Skin | 15 | 0 |
| Nervous system disorders | 56 | 3.7 |
| Headache | 23 | 0.9 |
| Dizziness | 22 | 0 |
| Neuropathy | 24 | 0 |
| Dysgeusia | 11 | 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, continuedThe following adverse reactions are discussed in greater detail in other sections of the label: Neutropenia [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Nausea and Vomiting [see Warnings and Precautions (5.4) ] The most common adverse reactions including laboratory abnormalities: TRODELVY as a single agent (incidence ≥ 25%) were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, nausea, diarrhea, decreased lymphocyte count, fatigue, alopecia, increased glucose, constipation, vomiting, decreased albumin, increased alkaline phosphatase, decreased appetite, abdominal pain, decreased creatinine clearance, decreased magnesium, and decreased potassium. ( 6.1 ) TRODELVY in combination with pembrolizumab (incidence ≥25%) were decreased neutrophil count, decreased hemoglobin, decreased leukocyte count, diarrhea, nausea, decreased lymphocyte count, fatigue, alopecia, increased alkaline phosphatase, increased glucose, increased alanine aminotransferase, constipation, increased aspartate aminotransferase, rash, decreased potassium, increased lactate dehydrogenase, vomiting, abdominal pain, headache, increased eosinophils, and decreased albumin.
Source: FDA drug label, Gilead Sciences, Inc., effective June 24, 2026 (SPL set 57a597d2-03f0-472e-b148-016d7169169d), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,518 reports list sacituzumab govitecan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 929 are coded as a death and 1,231 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 2022 (1,248, against a median of 112 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 15 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?
- Sacituzumab govitecan: 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