Minocycline: adverse event reports filed with FDA

5,801

reports as suspect product

0% of all reports · about 264 a year

434

reports, 12 months to June 2026

838 in the 12 months before

85.5%

marked serious by the reporter

80.6% across the class

19.6%

record death among outcomes, as reported

1,139 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 Minocycline reports recording the termmedian drug in tetracycline-class drug

1. Drug ineffectivethe medicine did not work as expected24%1,393
2. Off label useused for a purpose or in a way not on the label18.5%1,071
3. Drug intolerancethe medicine was not tolerated13.6%790
4. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease13.3%769
5. Drug hypersensitivityan allergic-type reaction to a medicine12.4%720
6. Arthralgiajoint pain12%694
7. Nauseafeeling sick11.9%688
8. Painpain, site not specified11.5%670
9. Joint swellinga swollen joint11.2%652
10. Rashskin rash10%580
11. General physical health deteriorationgeneral decline in health9.8%570
12. Maternal exposure during pregnancythe mother took the medicine during pregnancy9.6%555
13. Condition aggravatedthe condition being treated got worse9.5%551
14. C-reactive protein increased9.3%542
15. Treatment failurethe treatment did not work9.3%540
16. Fatiguetiredness9.2%532
17. Headachehead pain9.2%531
18. Hypertensionhigh blood pressure9.1%525
19. Systemic lupus erythematosuslupus, an autoimmune disease8.8%512
20. Contraindicated product administered8.8%508
21. Pneumonialung infection8.8%508
22. Hepatic enzyme increasedraised liver enzymes8.7%507
23. Infusion related reactiona reaction during or soon after an infusion8.7%504
24. Osteoarthritis8.7%504
25. Synovitis8.6%499
26. Abdominal discomfortstomach discomfort8.5%494
27. Product use in unapproved indicationused for a purpose not on the label8.5%494
28. Pemphigus8.3%484
29. Glossodynia8.3%480
30. Dizzinesslight-headedness or unsteadiness8.2%477

Top 30 of 1,029 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 6 drugs in the tetracycline-class drug 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 36,316 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. 46.8% 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 5,801 reports.

Drugs most often listed in the same reports

Other products listed in reports where Minocycline 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 tetracycline-class drug 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 Minocycline as a suspect or interacting product; reports listing it only as a concomitant medication (5,717) 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.