Doxycycline: adverse event reports filed with FDA

19,652

reports as suspect product

0.1% of all reports · about 874 a year

2,103

reports, 12 months to June 2026

2,749 in the 12 months before

85.6%

marked serious by the reporter

80.6% across the class

10.6%

record death among outcomes, as reported

2,084 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 reports recording the termmedian drug in tetracycline-class drug

1. Drug ineffectivethe medicine did not work as expected12.9%2,543
2. Off label useused for a purpose or in a way not on the label9.6%1,892
3. Vomitingbeing sick7.7%1,517
4. Rashskin rash7.7%1,513
5. Nauseafeeling sick7.7%1,511
6. Condition aggravatedthe condition being treated got worse6.4%1,257
7. Headachehead pain6.1%1,198
8. Drug hypersensitivityan allergic-type reaction to a medicine6%1,185
9. Fatiguetiredness5.9%1,162
10. Malaisegeneral feeling of being unwell5.9%1,157
11. Dyspnoeashortness of breath5.8%1,134
12. Diarrhoealoose or frequent stools5.5%1,077
13. Pruritusitching5.3%1,038
14. Pyrexiafever4.9%954
15. Infectionan infection, type not specified4.8%953
16. Treatment failurethe treatment did not work4.7%929
17. Painpain, site not specified4.7%921
18. Arthralgiajoint pain4.6%898
19. Hypersensitivityan allergic-type reaction4.5%880
20. Abdominal discomfortstomach discomfort4.4%860
21. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease4.2%816
22. Product use in unapproved indicationused for a purpose not on the label4.1%809
23. Dizzinesslight-headedness or unsteadiness4.1%801
24. Hypertensionhigh blood pressure4%784
25. Wheezingwheezing3.9%757
26. Drug intolerancethe medicine was not tolerated3.8%754
27. Hypoaesthesianumbness3.8%754
28. Abdominal pain upperupper stomach pain3.8%747
29. Joint swellinga swollen joint3.7%719
30. Urticariahives3.6%700

Top 30 of 2,209 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. 39.5% 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 19,652 reports.

Drugs most often listed in the same reports

Other products listed in reports where Doxycycline 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 as a suspect or interacting product; reports listing it only as a concomitant medication (31,699) 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.