Minocycline hydrochloride: adverse event reports filed with FDA

2,688

reports as suspect product

0% of all reports · about 119 a year

419

reports, 12 months to June 2026

479 in the 12 months before

94.6%

marked serious by the reporter

80.6% across the class

44.9%

record death among outcomes, as reported

1,207 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 hydrochloride reports recording the termmedian drug in tetracycline-class drug

1. Drug ineffectivethe medicine did not work as expected40.6%1,092
2. Off label useused for a purpose or in a way not on the label37%994
3. Drug intolerancethe medicine was not tolerated32.1%863
4. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease30%807
5. Painpain, site not specified27.6%741
6. Joint swellinga swollen joint23.7%638
7. Arthralgiajoint pain23.5%632
8. Drug hypersensitivityan allergic-type reaction to a medicine23.4%629
9. Contraindicated product administered23.3%627
10. Rashskin rash22.6%607
11. Nauseafeeling sick22%591
12. Systemic lupus erythematosuslupus, an autoimmune disease21.6%581
13. General physical health deteriorationgeneral decline in health21.3%573
14. C-reactive protein increased21.2%569
15. Wound21.1%568
16. Pericarditisinflammation of the sac around the heart20.9%561
17. Product use in unapproved indicationused for a purpose not on the label20.7%556
18. Condition aggravatedthe condition being treated got worse20.6%553
19. Pemphigus20.4%549
20. Abdominal discomfortstomach discomfort20.2%543
21. Infusion related reactiona reaction during or soon after an infusion20.2%542
22. Synovitis20.1%541
23. Fatiguetiredness19.9%534
24. Intentional product use issuedeliberate use not as intended19.8%533
25. Maternal exposure during pregnancythe mother took the medicine during pregnancy19.8%531
26. Pneumonialung infection19%511
27. Treatment failurethe treatment did not work18.8%506
28. Hepatic enzyme increasedraised liver enzymes18.6%500
29. Headachehead pain18.4%495
30. Osteoarthritis18.2%489

Top 30 of 621 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. 18.6% 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 2,688 reports.

Drugs most often listed in the same reports

Other products listed in reports where Minocycline hydrochloride 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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,630) 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.