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What the label lists and what reports show

Caspofungin side effects

Caspofungin's FDA label: “Most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased.” FAERS holds 4,684 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 pneumonia (203 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the caspofungin FDA label on DailyMed (effective October 11, 2024, Merck Sharp & Dohme LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased.

Table 2: Adverse Reactions Among Patients with Persistent Fever and Neutropenia Incidence 7.5% or greater for at Least One Treatment Group

Adverse ReactionsCANCIDAS 70 mg on Day 1, then 50 mg once daily for the remainder of treatment; daily dose…AmBisome 3 mg/kg/day; daily dose was increased to 5 mg/kg for 74 patients. N=547 (percent)
All Systems, Any Adverse Reaction9597
Investigations5863
Alanine Aminotransferase Increased1820
Blood Alkaline Phosphatase Increased1523
Blood Potassium Decreased1523
Aspartate Aminotransferase Increased1417
Blood Bilirubin Increased1014
Blood Magnesium Decreased79
Blood Glucose Increased69
Bilirubin Conjugated Increased59
Blood Urea Increased48
Blood Creatinine Increased311
General Disorders and Administration Site Conditions5763
Pyrexia2729
Chills2331
Edema Peripheral1112
Mucosal Inflammation68
Gastrointestinal Disorders5055
Diarrhea2016
Nausea1120
Abdominal Pain911
Vomiting917
Respiratory, Thoracic and Mediastinal Disorders4749
Dyspnea910
Skin and Subcutaneous Tissue Disorders4237

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, continued

The following serious adverse reactions are discussed in detail in another section of the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hepatic Effects [see Warnings and Precautions (5.2) ] Elevated Liver Enzymes During Concomitant Use With Cyclosporine [see Warnings and Precautions (5.3) ] Adults: Most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased. ( 6.1 ) Pediatric Patients: Most common adverse reactions (incidence ≥10%) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 CANCIDAS 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, Merck Sharp & Dohme LLC, effective October 11, 2024 (SPL set 3bad23a6-09a6-4194-9182-093ed61bc71c), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,684 reports list caspofungin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,668 are coded as a death and 2,028 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, 8 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

  • Drug Ineffective (a use or a product term, not a reaction)669
  • Off Label Use (a use or a product term, not a reaction)246
  • Death (an outcome recorded in the report)226
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)209
  • Pneumonia (named in the label)203
  • Pyrexia (named in the label)197
  • Sepsis (named in the label)192
  • Septic Shock192
  • Febrile Neutropenia (named in the label)168
  • Multiple Organ Dysfunction Syndrome145
  • Respiratory Failure (named in the label)131
  • Renal Failure (named in the label)124
  • Drug Interaction (a use or a product term, not a reaction)123
  • Fungal Infection (a use or a product term, not a reaction)123
  • Thrombocytopenia (named in the label)117
  • Drug Reaction With Eosinophilia And Systemic Symptoms115
  • Acute Kidney Injury114
  • Cholestasis110
  • Hypokalaemia (named in the label)110
  • Systemic Mycosis109
  • Drug Resistance108
  • Multi-Organ Failure107
  • Bronchopulmonary Aspergillosis106
  • Pancytopenia104
  • Platelet Count Decreased98

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Caspofungin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions