MedDRA preferred term · a bowel infection with C. difficile

Clostridium difficile colitis: adverse event reports recording this term

10,478 reports to FDA record it, 2005–2026; 0.1% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

10,478
reports recording the term: 0.1% of all reports; 631
reports, 12 months to June 2026: 599 in the 12 months before; 97.8%
marked serious by the reporter: 57.4% across all reports; 19%
record death among outcomes, as reported: 9.1% across all reports

"Clostridium difficile colitis" (in plain words, a bowel infection with C. difficile) is a MedDRA preferred term recorded in 10,478 adverse event reports received by FDA, 0.1% of the database, from October 2005 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

631 reports recorded it in the 12 months to June 2026, close to the 599 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 97.8% are marked serious, 19% include death among the outcomes and 69.3% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Cyclophosphamide, Prednisone and Dexamethasone. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. 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

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Cyclophosphamide	Alkylating drug	774	0.5%
Prednisone	Corticosteroid	720	0.4%
Dexamethasone	Corticosteroid	600	0.5%
Etoposide	Topoisomerase inhibitor	582	0.9%
Methotrexate	Folate analog metabolic inhibitor	550	0.3%
Cytarabine	Nucleoside metabolic inhibitor	540	1.1%
Revlimid	Thalidomide analog	406	0.1%
Ciprofloxacin	Fluoroquinolone antibacterial	398	1%
Metronidazole	Nitroimidazole antimicrobial	372	1.5%
Tacrolimus	Calcineurin inhibitor immunosuppressant	372	0.4%
Mycophenolate mofetil	Antimetabolite immunosuppressant	336	0.4%
Methylprednisolone	Corticosteroid	326	0.7%
Rituximab	CD20-directed cytolytic antibody	319	0.2%
Filgrastim	Leukocyte growth factor	308	2.9%
Vancomycin	Glycopeptide antibacterial	297	1%
Vincristine	—	286	0.5%
Carboplatin	Platinum-based drug	269	0.3%
Vincristine sulfate	Vinca alkaloid	268	1%
Mercaptopurine	Nucleoside metabolic inhibitor	245	2.3%
Cyclosporine	Calcineurin inhibitor immunosuppressant	244	0.6%
Meropenem	Penem antibacterial	236	1.5%
Daunorubicin	—	230	2.7%
Humira	—	219	0%
Clindamycin	Lincosamide antibacterial	215	1.7%
Hydrocortisone	Corticosteroid	211	1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Corticosteroid	2,285	0.3%	0%
Nucleoside metabolic inhibitor	1,256	0.4%	0.1%
Alkylating drug	1,173	0.5%	0.1%
Cephalosporin antibacterial	773	1.4%	1.1%
Calcineurin inhibitor immunosuppressant	675	0.3%	0%
Fluoroquinolone antibacterial	659	0.7%	0.3%
Folate analog metabolic inhibitor	638	0.2%	0%
Topoisomerase inhibitor	621	0.7%	0.1%
Thalidomide analog	567	0.1%	0.1%
Penicillin-class antibacterial	515	0.8%	0.5%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 21.1%114

2 to 113.5%364

12 to 171.6%172

18 to 4411.2%1,174

45 to 6422.7%2,377

65 to 7417%1,778

75 and over19%1,987

Age not given24%2,512

Patient sex

Female49.8%5,218

Male38.9%4,080

Not given11.3%1,180

Grey bar: all 20,646,523 reports in the database. 53.6% of these reports give the United States as the country.

Questions about "Clostridium difficile colitis"

What does "Clostridium difficile colitis" mean in an adverse event report?

In plain language: a bowel infection with C. difficile. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record clostridium difficile colitis?

10,478 reports through June 2026 (0.1% of all reports), 631 of them in the latest 12 months.

Which drugs appear most often in these reports?

Cyclophosphamide (774), Prednisone (720), Dexamethasone (600), Etoposide (582) and Methotrexate (550). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

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."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.