What the label lists and what reports show
Anidulafungin side effects
Anidulafungin's FDA label: “Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension.” FAERS holds 1,600 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 multiple organ dysfunction syndrome (173 reports).
- No generic listed
Check it at the source: the anidulafungin FDA label on DailyMed (effective August 19, 2025, Roerig); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension.
Table 2: Adverse Reactions Reported in ≥5% of Adult Patients Receiving ERAXIS or Fluconazole Therapy for Candidemia/other Candida Infections A patient who experienced multiple reactions within a Body System or preferred…
| Adverse Reaction | ERAXIS 100 mg N=131 N (%) | Fluconazole 400 mg N=125 N (%) |
|---|---|---|
| Subjects with a least one adverse reaction | 130 (99) | 122 (98) |
| Gastrointestinal disorders | 81 (62) | 72 (58) |
| Nausea | 32 (24) | 15 (12) |
| Diarrhea | 24 (18) | 23 (18) |
| Vomiting | 23 (18) | 12 (10) |
| Constipation | 11 (8) | 14 (11) |
| Abdominal pain | 8 (6) | 16 (13) |
| General disorders and administration site conditions | 70 (53) | 76 (61) |
| Pyrexia | 23 (18) | 23 (18) |
| Edema peripheral | 14 (11) | 16 (13) |
| Chest pain | 7 (5) | 6 (5) |
| Respiratory, thoracic, and mediastinal disorders | 67 (51) | 55 (44) |
| Dyspnea | 15 (12) | 4 (3) |
| Pleural effusion | 13 (10) | 11 (9) |
| Cough | 9 (7) | 7 (6) |
| Respiratory distress | 8 (6) | 2 (2) |
| Investigations | 66 (50) | 46 (37) |
| Blood alkaline phosphatase increased | 15 (12) | 14 (11) |
| White blood cell increased | 11 (8) | 3 (2) |
| Hepatic enzyme increased | 7 (5) | 14 (11) |
| Blood creatinine increased | 7 (5) | 1 (1) |
| Metabolism and nutrition disorders | 61 (47) | 61 (49) |
| Hypokalemia | 33 (25) | 24 (19) |
| Hypomagnesemia | 15 (12) | 14 (11) |
| Hypoglycemia | 9 (7) | 10 (8) |
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 most serious adverse reactions are described elsewhere in other labeling sections: • Hepatic Adverse Reactions [see Warnings and Precautions (5.1) ] • Anaphylactic and Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Adults • Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension. ( 6.1 ) • Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia. ( 6.1 ) Pediatric Patients (1 month and older) Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 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, NDA021632 (Vicuron Holdings), as published by Roerig, effective August 19, 2025 (SPL set a88d9010-55fb-4a02-baff-042cd27688ea), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,600 reports list anidulafungin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 688 are coded as a death and 770 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, 9 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?
- Anidulafungin: 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