What the label lists and what reports show
Mirvetuximab soravtansine side effects
Mirvetuximab soravtansine's FDA label: “The most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy …” FAERS holds 1,651 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 neuropathy peripheral (114 reports).
- No generic listed
- Boxed warning
Check it at the source: the mirvetuximab soravtansine FDA label on DailyMed (effective July 14, 2025); 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 ELAHERE?ELAHERE can cause serious side effects, including: See “What is the most important information I should know about ELAHERE?” Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain. Peripheral neuropathy. Nerve problems called peripheral neuropathy are common with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness. […]
Source: FDA drug label, ImmunoGen, Inc., effective July 14, 2025 (SPL set 00c424b5-6ccd-48ab-9e88-1986451120e2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.
Table 6: Adverse Reactions (≥10%) in Patients with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Received ELAHERE in Study 0417
| Adverse Reaction | All Grades N=106 (%) | Grade 3-4 N=106 (%) |
|---|---|---|
| Blurred Vision ※ | 50 | 7 |
| Keratopathy | 37 | 9 |
| Dry eye | 27 | 2 |
| Cataract | 18 | 3 |
| Photophobia | 17 | 0 |
| Eye pain | 10 | 0 |
| Fatigue | 49 | 3 |
| Nausea | 40 | 0 |
| Abdominal pain | 36 | 7 |
| Diarrhea | 31 | 3 |
| Constipation | 30 | 1 |
| Vomiting | 19 | 0 |
| Abdominal distension | 11 | 0 |
| Peripheral neuropathy | 33 | 2 |
| Decreased appetite | 18 | 1 |
| Arthralgia | 17 | 0 |
| Myalgia | 10 | 0 |
| Dyspnea^ | 12 | 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 elsewhere in the labeling: Ocular Disorders [see Warnings and Precautions ( 5.1 )]. Pneumonitis [see Warnings and Precautions ( 5.2 )]. Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )]. The most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 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. …
Source: FDA drug label, ImmunoGen, Inc., effective July 14, 2025 (SPL set 00c424b5-6ccd-48ab-9e88-1986451120e2), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,651 reports list mirvetuximab soravtansine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 196 are coded as a death and 265 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 22 reactions below, 18 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?
- Mirvetuximab soravtansine: 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