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clonidine Side Effects

Also known as: Catapres

Analysis of 49,370 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

49,370

Death-Related

5,854

11.9% of reports

Hospitalizations

17,724

35.9% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
3,866
PAIN
3,038
FATIGUE
2,925
NAUSEA
2,920
OFF LABEL USE
2,852
HEADACHE
2,798
HYPERTENSION
2,595
DYSPNOEA
2,296
DIARRHOEA
2,201
CHRONIC KIDNEY DISEASE
2,113
VOMITING
2,031
RENAL FAILURE
1,916
DIZZINESS
1,876
ACUTE KIDNEY INJURY
1,818
BLOOD PRESSURE INCREASED
1,691
ANXIETY
1,598
HYPOTENSION
1,542
DEATH
1,507
ASTHENIA
1,438
BACK PAIN
1,379

Who Reports Side Effects

Gender Distribution

Female 26,812 (59%)
Male 18,487 (41%)
Unknown 122

Age Distribution

0-17 4,180 (13%)
18-44 5,652 (17%)
45-64 11,917 (37%)
65-74 6,124 (19%)
75+ 4,748 (15%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 5,854 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 1,501
COMPLETED SUICIDE 1,277
TOXICITY TO VARIOUS AGENTS 497
CARDIAC ARREST 414
RENAL FAILURE 392
CARDIO-RESPIRATORY ARREST 356
PAIN 337
CHRONIC KIDNEY DISEASE 330
ACUTE KIDNEY INJURY 308
HYPERTENSION 307
OFF LABEL USE 283
END STAGE RENAL DISEASE 259
PNEUMONIA 258
DYSPNOEA 255
FATIGUE 249
DRUG INEFFECTIVE 224
NAUSEA 221
PYREXIA 221
OVERDOSE 217
HEADACHE 205

Reactions in Hospitalization Reports

Top reactions in 17,724 reports where hospitalization was an outcome.

Reaction Reports
HYPERTENSION 1,258
DYSPNOEA 1,187
NAUSEA 1,143
VOMITING 1,092
DRUG INEFFECTIVE 994
PAIN 986
HYPOTENSION 985
FATIGUE 964
PNEUMONIA 937
OFF LABEL USE 892
DIARRHOEA 885
RENAL FAILURE 845
FALL 829
ACUTE KIDNEY INJURY 826
HEADACHE 799
ASTHENIA 749
DIZZINESS 741
PYREXIA 692
CARDIAC FAILURE CONGESTIVE 671
TOXICITY TO VARIOUS AGENTS 669

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What the FAERS Data Reveals About clonidine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 49,370 voluntary reports linked to clonidine and its brand equivalents (Catapres), spanning 2004 through 2025. Of those, 5,854 (11.9%) listed death as an outcome and 17,724 (35.9%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 59% were female and 41% male; age distribution skews toward 45-64, with 11,917 reports in that bracket. The single most reported reaction is drug ineffective with 3,866 submissions, followed by pain and fatigue.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.