Drugs › Echinocandin antifungal
Brand name · Micafungin sodium
Mycamine: adverse event reports filed with FDA
1,406 reports list it as a suspect or interacting product, 2005–2026. Class: Echinocandin antifungal. Also reported as Mycamine Injection.
- 1,406
- reports as suspect product
- 0% of all reports · about 68 a year
- 15
- reports, 12 months to June 2026
- 23 in the 12 months before
- 58.9%
- marked serious by the reporter
- 87.9% across the class
- 23.3%
- record death among outcomes, as reported
- 327 reports · not verified by FDA
1,406 adverse event reports received by FDA list the brand name Mycamine (micafungin sodium) as a suspect or interacting product, from October 2005 to April 2026. A further 684 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 15 reports listed it, down 35% from 23 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 68 reports a year and 0% of the 20,646,523 reports in the database, and 19.1% of the reports for the echinocandin antifungal class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are off label use (34.4%), death (9.7%) and product use issue (6.6%). A report can list several reactions, so shares add to more than 100%; 195 different terms appear across these reports. Off label use is recorded in 34.4% of these reports, a larger share than in the median echinocandin antifungal drug (10.6%).
58.9% of the reports are marked serious by the reporter (87.9% across the class); 23.3% record death among the outcomes and 20.7% record hospitalisation, as reported. 48.7% of the reports came from consumers, and the largest patient age group is 45 to 64 (20.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Mycamine reports recording the termmedian drug in echinocandin antifungal
- Off label useused for a purpose or in a way not on the label34.4%483
- Deaththe patient died; cause not stated by this term9.7%137
- Product use issuea problem in how the product was used6.6%93
- Fungal infectiona fungal infection5.8%81
- Product use in unapproved indicationused for a purpose not on the label5.8%81
- Bacterial infectiona bacterial infection5.3%74
- Cellulitisa skin infection5.2%73
- Clostridium difficile colitisa bowel infection with C. difficile5.2%73
- Lymphoid tissue hypoplasia5.2%73
- Drug ineffectivethe medicine did not work as expected5.1%72
- Lymphopenia5%71
- Thymus hypoplasia5%71
- Disseminated aspergillosis4.8%68
- Cytomegalovirus viraemia4.7%66
- Renal failurekidney failure2.6%37
- Anaemialow red blood cells2.3%33
- Astheniaweakness or lack of energy1.8%26
- Herpes simplex oesophagitis1.8%25
- Glomerular filtration rate decreasedreduced kidney filtering1.7%24
- Infectionan infection, type not specified1.7%24
- Dysphagiadifficulty swallowing1.6%23
- Multi-organ failure1.6%22
- Sepsisa severe body-wide response to infection1.3%18
- Toxic epidermal necrolysisa severe skin reaction with peeling1.3%18
- Candida infectionthrush, a yeast infection1.1%16
- Hepatic failureliver failure1%14
- Pyrexiafever1%14
- Aspartate aminotransferase increasedraised liver enzyme (AST)0.9%13
Top 30 of 195 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the echinocandin antifungal class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 7,377 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 53.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Candida infection | 99 | 7% |
| Fungal infection | 89 | 6.3% |
| Sepsis | 77 | 5.5% |
| Acute lymphocytic leukaemia | 54 | 3.8% |
| Systemic candida | 33 | 2.3% |
| Infection | 31 | 2.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,406 reports.
In context
| Measure | Mycamine | Echinocandin antifungal | All reports |
|---|---|---|---|
| Reports as suspect product | 1,406 | 7,377 | 20,646,523 |
| Share of that pool | — | 19.1% | 0% |
| Reports, latest 12 months | 15 | — | 1,332,454 |
| Marked serious | 58.9% | 87.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 233 | 367 | 91 |
| Hospitalisation recorded, per 1,000 reports | 207 | 369 | 213 |
| Consumer-filed share | 48.7% | 18.1% | 45.8% |
| Top term, share of reports | Off label use 34.4% | median 10.6% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the echinocandin antifungal class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Cancidas | brand | 2,296 | 18 | 90.9% |
| Micafungin | generic | 1,970 | 156 | 97.2% |
| Caspofungin acetate | generic | 1,011 | 94 | 95.3% |
| Anidulafungin | generic | 694 | 77 | 99.6% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Mycamine reports
How many adverse event reports has FDA received for Mycamine?
1,406 reports list Mycamine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 15 of them arrived in the latest 12 months. Another 684 list it only as a concomitant medication.
What reactions are recorded in Mycamine reports?
off label use (34.4%), death (9.7%), product use issue (6.6%), fungal infection (5.8%) and product use in unapproved indication (5.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Mycamine was responsible.
How serious are the reports?
58.9% are marked serious by the reporter. Among the outcomes recorded, 23.3% of reports include death and 20.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (48.7%), other health professional (20.7%) and physician (18.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Mycamine rising?
15 reports in the 12 months to June 2026, down 35% from 23 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Mycamine was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Mycamine?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Mycamine as a suspect or interacting product; reports listing it only as a concomitant medication (684) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.