What the label lists and what reports show
Micafungin side effects
Micafungin's FDA label: “Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache.” FAERS holds 6,383 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 pyrexia (470 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the micafungin FDA label on DailyMed (effective November 8, 2025, Sagent Pharmaceuticals); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache.
Table 6. Selected Adverse Reactions in Pediatric Patients with Candidemia and Other Candida Infections (C/IC), and in Hematopoietic Stem-Cell Recipients During Prophylaxis of Candida Infections
| Reaction | Micafungin n = 56 n (%) | Amphotericin B liposome n = 56 n (%) | Micafungin n = 43 n (%) | Fluconazole n = 48 n (%) |
|---|---|---|---|---|
| Gastrointestinal disorders | 22 (40) | 18 (32) | 43 (100) | 45 (94) |
| Vomiting | 10 (18) | 8 (14) | 28 (65) | 32 (67) |
| Diarrhea | 4 (7) | 5 (9) | 22 (51) | 31 (65) |
| Nausea | 4 (7) | 4 (7) | 30 (70) | 25 (52) |
| Abdominal pain | 2 (4) | 2 (4) | 15 (35) | 12 (25) |
| Abdominal distension | 1 (2) | 1 (2) | 8 (19) | 6 (13) |
| General disorders and administration site conditions | 14 (25) | 14 (25) | 41 (95) | 46 (96) |
| Pyrexia | 5 (9) | 9 (16) | 26 (61) | 31 (65) |
| Infusion-related reaction | 0 | 3 (5) | 7 (16) | 4 (8) |
| Skin and subcutaneous tissue disorders | 11 (20) | 8 (14) | 33 (77) | 38 (79) |
| Pruritus | 0 | 1 (2) | 14 (33) | 15 (31) |
| Rash | 1 (2) | 1 (2) | 13 (30) | 13 (27) |
| Urticaria | 0 | 1 (2) | 8 (19) | 4 (8) |
| Respiratory, thoracic and mediastinal disorders | 9 (16) | 13 (23) | 30 (70) | 33 (69) |
| Epistaxis | 0 | 0 | 4 (9) | 8 (17) |
| Blood and lymphatic system disorders | 17 (30) | 13 (23) | 40 (93) | 44 (92) |
| Thrombocytopenia | 5 (9) | 3 (5) | 31 (72) | 37 (77) |
| Neutropenia | 3 (5) | 4 (7) | 33 (77) | 34 (71) |
| Anemia | 10 (18) | 6 (11) | 22 (51) | 24 (50) |
| Febrile neutropenia | 0 | 0 | 7 (16) | 7 (15) |
| Investigations | 12 (21) | 8 (14) | 24 (56) | 25 (52) |
| Alanine aminotransferase increased | 0 | 0 | 7 (16) | 1 (2) |
| Urine output decreased | 0 | 0 | 10 (23) | 8 (17) |
| Cardiac disorders | 7 (13) | 3 (5) | 10 (23) | 17 (35) |
| Tachycardia | 2 (4) | 1 (2) | 7 (16) | 12 (25) |
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 clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hematological Effects [see Warnings and Precautions ( 5.2 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Renal Effects [see Warnings and Precautions ( 5.4 )] Infusion and Injection Site Reactions [see Warnings and Precautions ( 5.5 )] Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache. ( 6.1 ) In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: sepsis, acidosis, anemia, oxygen saturation decreased and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 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 clinical trials of micafungin cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Sagent Pharmaceuticals, effective November 8, 2025 (SPL set 33e579c1-b315-44cb-a690-e2dd2cdf44ee), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,383 reports list micafungin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,365 are coded as a death and 3,096 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 17 reactions below, 11 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?
- Micafungin: 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