Clindamycin: adverse event reports filed with FDA

12,779

reports as suspect product

0.1% of all reports · about 568 a year

648

reports, 12 months to June 2026

940 in the 12 months before

73.7%

marked serious by the reporter

68.3% across the class

6.7%

record death among outcomes, as reported

851 reports · not verified by FDA

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 Clindamycin reports recording the termmedian drug in lincosamide antibacterial

1. Drug hypersensitivityan allergic-type reaction to a medicine16.7%2,136
2. Drug ineffectivethe medicine did not work as expected12.1%1,549
3. Diarrhoealoose or frequent stools8.3%1,064
4. Rashskin rash7.5%958
5. Nauseafeeling sick5.3%673
6. Off label useused for a purpose or in a way not on the label4.6%586
7. Pruritusitching4.3%546
8. Dyspnoeashortness of breath4.1%521
9. Pyrexiafever4.1%521
10. Condition aggravatedthe condition being treated got worse3.9%495
11. Urticariahives3.3%417
12. Painpain, site not specified3.1%398
13. Vomitingbeing sick3%382
14. Erythemaskin redness2.8%360
15. Clostridium difficile infection2.8%359
16. Acute kidney injurysudden loss of kidney function2.8%357
17. Product use in unapproved indicationused for a purpose not on the label2.6%330
18. Hypersensitivityan allergic-type reaction2.6%326
19. Malaisegeneral feeling of being unwell2.6%326
20. Rash maculo-papulara rash of flat and raised spots2.5%323
21. Fatiguetiredness2.5%319
22. Abdominal pain upperupper stomach pain2.4%306
23. Arthralgiajoint pain2.4%306
24. Headachehead pain2.4%301
25. Abdominal discomfortstomach discomfort2.3%289
26. Acute generalised exanthematous pustulosis2.2%285
27. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.2%276
28. Coughcough2.2%275
29. Hypertensionhigh blood pressure1.9%238
30. Drug interactionan interaction between medicines1.7%223

Top 30 of 1,816 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 lincosamide antibacterial 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 20,239 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 50% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 12,779 reports.

Drugs most often listed in the same reports

Other products listed in reports where Clindamycin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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 lincosamide antibacterial class

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.

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 Clindamycin as a suspect or interacting product; reports listing it only as a concomitant medication (15,426) 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.