Clonidine: adverse event reports filed with FDA

11,712

reports as suspect product

0.1% of all reports · about 521 a year

713

reports, 12 months to June 2026

759 in the 12 months before

79.2%

marked serious by the reporter

75.5% across the class

22.5%

record death among outcomes, as reported

2,635 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 Clonidine reports recording the termmedian drug in central alpha-2 adrenergic agonist

1. Drug ineffectivethe medicine did not work as expected14.3%1,671
2. Completed suicidedeath by suicide11%1,286
3. Off label useused for a purpose or in a way not on the label10.3%1,202
4. Painpain, site not specified8.3%976
5. Hypertensionhigh blood pressure8.1%954
6. Headachehead pain7.2%845
7. Toxicity to various agentspoisoning or toxic effect of one or more substances6.8%800
8. Fatiguetiredness6.7%780
9. Overdosea dose above the recommended amount6.6%775
10. Hypotensionlow blood pressure6.5%756
11. Hyperhidrosisexcessive sweating5.5%643
12. Hypersensitivityan allergic-type reaction5.1%599
13. Product use issuea problem in how the product was used5%580
14. Drug hypersensitivityan allergic-type reaction to a medicine4.6%536
15. Hepatic enzyme increasedraised liver enzymes4.4%520
16. Exposure during pregnancythe medicine was taken during pregnancy4.4%510
17. Immunodeficiency4.2%491
18. Food allergy4.2%489
19. Somnolencedrowsiness4.1%486
20. Intentional product misusedeliberate use not as intended4.1%485
21. Bradycardiaslow heart rate4.1%482
22. Constipationconstipation4.1%482
23. Blood pressure increaseda raised blood pressure reading4.1%476
24. Nauseafeeling sick4%467
25. Asthmaasthma3.9%452
26. Back painback pain3.9%451
27. Upper respiratory tract infectiona cold or similar infection3.9%451
28. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease3.8%450
29. Rash erythematousa red rash3.7%436
30. Pyrexiafever3.7%433

Top 30 of 1,431 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 13 drugs in the central alpha-2 adrenergic agonist 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 31,745 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. 69.6% 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 11,712 reports.

Drugs most often listed in the same reports

Other products listed in reports where Clonidine 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 central alpha-2 adrenergic agonist 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 Clonidine as a suspect or interacting product; reports listing it only as a concomitant medication (38,924) 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.