What the label lists and what reports show
Mesna side effects
Mesna's FDA label: “The most common adverse reactions (> 10%) when mesna is given with ifosfamide are nausea, vomiting, constipation, leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia, granulocytopenia, diarrhea, asthenia, abdominal pain, headache, alopecia, and …” FAERS holds 8,413 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 febrile neutropenia (1,288 reports).
- Generic listed
Check it at the source: the mesna FDA label on DailyMed (effective December 17, 2018, Baxter Healthcare Company); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (> 10%) when mesna is given with ifosfamide are nausea, vomiting, constipation, leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia, granulocytopenia, diarrhea, asthenia, abdominal pain, headache, alopecia, and somnolence.
Table 3: Adverse Reactions in ≥ 5% of Patients Receiving Mesna in combination with…
| Mesna Regimen | Intravenous-Intravenous-Intravenous Intravenous dosing of ifosfamide and mesna followed… | Intravenous-Oral-Oral |
|---|---|---|
| N exposed | 119 (100.0%) | 119 (100%) |
| Incidence of AEs | 101 (84.9%) | 106 (89.1%) |
| Nausea | 65 (54.6) | 64 (53.8) |
| Vomiting | 35 (29.4) | 45 (37.8) |
| Constipation | 28 (23.5) | 21 (17.6) |
| Leukopenia | 25 (21.0) | 21 (17.6) |
| Fatigue | 24 (20.2) | 24 (20.2) |
| Fever | 24 (20.2) | 18 (15.1) |
| Anorexia | 21 (17.6) | 19 (16.0) |
| Thrombocytopenia | 21 (17.6) | 16 (13.4) |
| Anemia | 20 (16.8) | 21 (17.6) |
| Granulocytopenia | 16 (13.4) | 15 (12.6) |
| Asthenia | 15 (12.6) | 21 (17.6) |
| Abdominal Pain | 14 (11.8) | 18 (15.1) |
| Alopecia | 12 (10.1) | 13 (10.9) |
| Dyspnea | 11 (9.2) | 11 (9.2) |
| Chest Pain | 10 (8.4) | 11 (9.2) |
| Hypokalemia | 10 (8.4) | 11 (9.2) |
| Diarrhea | 9 (7.6) | 17 (14.3) |
| Dizziness | 9 (7.6) | 5 (4.2) |
| Headache | 9 (7.6) | 13 (10.9) |
| Pain | 9 (7.6) | 10 (8.4) |
| Sweating Increased | 9 (7.6) | 2 (1.7) |
| Back Pain | 8 (6.7) | 6 (5.0) |
| Hematuria | 8 (6.7) | 7 (5.9) |
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 following are discussed in more detail in other sections of the labeling. • Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] • Dermatological Toxicity [ see Warnings and Precautions (5.2) ] • Benzyl Alcohol Toxicity [ see Warnings and Precautions (5.3) ] • Laboratory Test Interferences [ see Warnings and Precautions (5.4) ] • Use in Patients with a History of Adverse Reactions to Thiol Compounds [ see Warnings and Precautions (5.5) ] The most common adverse reactions (> 10%) when mesna is given with ifosfamide are nausea, vomiting, constipation, leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia, granulocytopenia, diarrhea, asthenia, abdominal pain, headache, alopecia, and somnolence. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472, 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, Baxter Healthcare Company, effective December 17, 2018 (SPL set a880160b-fa82-453a-a971-29ab897876a7), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,413 reports list mesna among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,754 are coded as a death and 3,955 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 19 reactions below, 7 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?
- Mesna: 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