Drug Safety Information for ANCOBON (Flucytosine)

Safety-related Labeling Changes for ANCOBON (FLUCYTOSINE) Rx Drug: FDA Link

Adverse Drug Reactions for ANCOBON* (Flucytosine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ANCOBON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective32
2Pyrexia24
3Immune reconstitution syndrome24
4Headache24
5Renal impairment23
6Hypokalaemia20
7Cardio-respiratory arrest19
8Renal failure acute18
9Cryptococcosis15
10Blood creatinine increased15
11Meningitis cryptococcal14
12Nausea13
13Anaemia13
14Multi-organ failure11
15Diarrhoea11
16Hypotension10
17Shock10
18Pleural effusion10
19Chest pain10
20Respiratory failure10

* This side effect also appears in "Top 10 Side Effects of ANCOBON " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ANCOBON
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Meningitis cryptococcal145
2Product used for unknown indication107
3Cryptococcosis88
4Disseminated cryptococcosis40
5Fungal infection32
6Drug level28
7Renal impairment28
8Meningitis20
9Candidiasis*18
10Bronchopulmonary aspergillosis13

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ANCOBON

Total Reports Filed with FDA: 1369


Number of FDA Adverse Event Reports by Patient Age for ANCOBON

Total Reports Filed with FDA: 1369*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Flucytosine (Flucytosine, Ancotil, Ancobon)

Charts are based on 1369 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ANCOBON Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.