Doxycycline hyclate: adverse event reports filed with FDA

6,807

reports as suspect product

0% of all reports · about 305 a year

620

reports, 12 months to June 2026

894 in the 12 months before

60.8%

marked serious by the reporter

80.6% across the class

21.9%

record death among outcomes, as reported

1,488 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 Doxycycline hyclate reports recording the termmedian drug in tetracycline-class drug

1. Drug hypersensitivityan allergic-type reaction to a medicine30.4%2,072
2. Off label useused for a purpose or in a way not on the label13.7%930
3. Drug ineffectivethe medicine did not work as expected13.1%894
4. Nauseafeeling sick13%886
5. Vomitingbeing sick12.9%880
6. Rashskin rash12.5%854
7. Fatiguetiredness11.4%775
8. Condition aggravatedthe condition being treated got worse10.8%733
9. Headachehead pain10.6%723
10. Painpain, site not specified10.3%700
11. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease10.2%692
12. Hypersensitivityan allergic-type reaction10.2%691
13. Hypertensionhigh blood pressure10%680
14. Pruritusitching9.9%677
15. Hypoaesthesianumbness9.7%662
16. Infectionan infection, type not specified9.7%659
17. Dyspnoeashortness of breath9.6%656
18. Urticariahives9.5%646
19. Diarrhoealoose or frequent stools9.4%640
20. Hepatic enzyme increasedraised liver enzymes9.1%622
21. Dizzinesslight-headedness or unsteadiness9.1%621
22. Abdominal discomfortstomach discomfort9%616
23. Infusion related reactiona reaction during or soon after an infusion9%612
24. Joint swellinga swollen joint9%610
25. Arthralgiajoint pain8.9%604
26. Impaired healingslow healing8.8%600
27. Drug intolerancethe medicine was not tolerated8.4%574
28. Helicobacter infection8.4%571
29. Wheezingwheezing8.4%571
30. Alopeciahair loss8.3%568

Top 30 of 926 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. 58.7% 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 6,807 reports.

Drugs most often listed in the same reports

Other products listed in reports where Doxycycline hyclate 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 Doxycycline hyclate as a suspect or interacting product; reports listing it only as a concomitant medication (10,570) 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.