Drug · FAERS side-effect profile with label screen
Clonidine Hydrochloride side effects: what 5,501 FDA adverse event reports show
Drug class
Centrally acting alpha 2 -adrenergic agonist
FDA label, Indications wording
Who reports
5,501 reports · 68% serious · 872 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Clonidine hydrochloride extended-release tablets is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. ( 1 ) Cl.
FDA label, Indications and Usage
What it is
Clonidine hydrochloride extended-release is a centrally acting alpha 2 -adrenergic agonist available as 0.1 mg extended-release tablets for oral administration. Each 0.1 mg tablet is equivalent to 0.087 mg of the free base.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 1Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 35
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 563 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 216 | 87.9 77.0–100.3ROR 91.4 · χ² 18,054 / p <1e-300 | 85.3 EB05 76.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 77.3 · ♀ 98% (drug 67%) · 97% clinician | no trial data cached |
| Prescribed overdose | 350 | 70.1 63.3–77.6ROR 74.8 · χ² 23,353 / p <1e-300 | 68.6 EB05 62.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 99.6 · ♀ 99% (drug 67%) · 93% clinician | no trial data cached |
| Immunodeficiency | 257 | 67.6 59.9–76.2ROR 70.8 · χ² 16,504 / p <1e-300 | 66.1 EB05 59.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 61.4 · ♀ 100% (drug 67%) | no trial data cached |
| Helicobacter infection | 175 | 66.5 57.4–77.0ROR 68.6 · χ² 11,027 / p <1e-300 | 64.9 EB05 57.2 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 58.7 · ♀ 100% (drug 67%) · 97% clinician | no trial data cached |
| Joint dislocation | 179 | 65.8 56.9–76.1ROR 68.0 · χ² 11,169 / p <1e-300 | 64.3 EB05 56.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 62.0 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Wound infection | 170 | 60.5 52.1–70.2ROR 62.4 · χ² 9,730 / p <1e-300 | 59.1 EB05 52.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · ♀ 99% (drug 67%) · 95% clinician | no trial data cached |
| Coeliac disease | 142 | 55.8 47.4–65.8ROR 57.3 · χ² 7,487 / p <1e-300 | 54.7 EB05 47.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 57.5 · ♀ 98% (drug 67%) | no trial data cached |
| Bursitis | 170 | 54.4 46.8–63.1ROR 56.1 · χ² 8,732 / p <1e-300 | 53.3 EB05 46.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 53.7 · ♀ 99% (drug 67%) | no trial data cached |
| Joint range of motion decreased | 175 | 50.5 43.6–58.5ROR 52.1 · χ² 8,331 / p <1e-300 | 49.6 EB05 43.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 53.4 · ♀ 98% (drug 67%) · 97% clinician | no trial data cached |
| Folliculitis | 135 | 50.4 42.6–59.6ROR 51.6 · χ² 6,402 / p <1e-300 | 49.4 EB05 42.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 49.7 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Autoimmune disorder | 120 | 48.3 40.4–57.7ROR 49.4 · χ² 5,444 / p <1e-300 | 47.4 EB05 40.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 43.4 · ♀ 96% (drug 67%) · 95% clinician | no trial data cached |
| Pemphigus | 149 | 46.2 39.4–54.1ROR 47.4 · χ² 6,461 / p <1e-300 | 45.4 EB05 39.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 38.9 · ♀ 100% (drug 67%) · 97% clinician | no trial data cached |
| Laryngitis | 124 | 44.0 36.9–52.4ROR 44.9 · χ² 5,106 / p <1e-300 | 43.2 EB05 37.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=124 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Hand deformity | 146 | 42.9 36.6–50.4ROR 44.1 · χ² 5,875 / p <1e-300 | 42.2 EB05 36.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 39.3 · ♀ 100% (drug 67%) · 99% clinician | no trial data cached |
| Foot deformity | 122 | 42.3 35.4–50.5ROR 43.2 · χ² 4,825 / p <1e-300 | 41.6 EB05 35.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 41.4 · ♀ 100% (drug 67%) · 97% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 114 | 39.5 32.9–47.4ROR 40.3 · χ² 4,199 / p <1e-300 | 38.9 EB05 33.2 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 37.8 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Pericarditis | 157 | 36.2 31.0–42.2ROR 37.2 · χ² 5,290 / p <1e-300 | 35.7 EB05 31.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 · ♀ 98% (drug 67%) · 96% clinician | no trial data cached |
| Hip arthroplasty | 138 | 34.9 29.6–41.2ROR 35.8 · χ² 4,471 / p <1e-300 | 34.4 EB05 29.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 30.1 · ♀ 100% (drug 67%) · 95% clinician | no trial data cached |
| Irritable bowel syndrome | 182 | 32.7 28.3–37.7ROR 33.8 · χ² 5,517 / p <1e-300 | 32.3 EB05 28.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 34.6 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Prescribed underdose | 165 | 31.7 27.3–36.9ROR 32.7 · χ² 4,845 / p <1e-300 | 31.4 EB05 27.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 45.5 · ♀ 100% (drug 67%) · 95% clinician | no trial data cached |
| Hepatic cirrhosis | 146 | 30.0 25.5–35.2ROR 30.7 · χ² 4,029 / p <1e-300 | 29.6 EB05 25.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 · ♀ 98% (drug 67%) · 98% clinician | no trial data cached |
| Fibromyalgia | 185 | 29.2 25.3–33.7ROR 30.2 · χ² 4,978 / p <1e-300 | 28.9 EB05 25.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 32.4 · ♀ 100% (drug 67%) · 94% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 341 | 28.3 25.5–31.4ROR 30.1 · χ² 8,913 / p <1e-300 | 28.1 EB05 25.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 39.8 · ♀ 96% (drug 67%) | no trial data cached |
| Sciatica | 114 | 27.5 23.0–33.1ROR 28.1 · χ² 2,871 / p <1e-300 | 27.2 EB05 23.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 31.0 · ♀ 98% (drug 67%) · 90% clinician | no trial data cached |
| Joint stiffness | 187 | 27.3 23.7–31.5ROR 28.2 · χ² 4,685 / p <1e-300 | 27.1 EB05 24.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 · ♀ 97% (drug 67%) · 95% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 153 | 26.2 22.4–30.7ROR 26.9 · χ² 3,664 / p <1e-300 | 26.0 EB05 22.7 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.7 · ♀ 98% (drug 67%) · 95% clinician | no trial data cached |
| Lower limb fracture | 123 | 24.7 20.7–29.4ROR 25.2 · χ² 2,754 / p <1e-300 | 24.4 EB05 21.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · ♀ 98% (drug 67%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 425 | 24.6 22.5–27.0ROR 26.6 · χ² 9,583 / p <1e-300 | 24.5 EB05 22.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · ♀ 98% (drug 67%) | no trial data cached |
| Pulmonary fibrosis | 122 | 24.4 20.5–29.1ROR 25.0 · χ² 2,704 / p <1e-300 | 24.2 EB05 20.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 · ♀ 97% (drug 67%) · 94% clinician | no trial data cached |
| Synovitis | 113 | 24.0 20.0–28.8ROR 24.5 · χ² 2,451 / p <1e-300 | 23.7 EB05 20.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · ♀ 100% (drug 67%) · 100% clinician | no trial data cached |
| Hepatic enzyme increased | 418 | 23.5 21.5–25.8ROR 25.4 · χ² 8,975 / p <1e-300 | 23.4 EB05 21.6 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 28.6 · ♀ 98% (drug 67%) · 92% clinician | no trial data cached |
| Wound | 169 | 23.3 20.0–27.0ROR 24.0 · χ² 3,562 / p <1e-300 | 23.1 EB05 20.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 99% (drug 67%) · 95% clinician | no trial data cached |
| Impaired healing | 197 | 23.0 20.0–26.3ROR 23.8 · χ² 4,098 / p <1e-300 | 22.8 EB05 20.2 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 23.0 · ♀ 96% (drug 67%) · 95% clinician | no trial data cached |
| Knee arthroplasty | 125 | 22.9 19.3–27.3ROR 23.5 · χ² 2,589 / p <1e-300 | 22.7 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · ♀ 100% (drug 67%) · 92% clinician | no trial data cached |
| Contraindicated product administered | 175 | 22.2 19.2–25.7ROR 22.9 · χ² 3,506 / p <1e-300 | 22.0 EB05 19.4 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 22.7 · ♀ 98% (drug 67%) | no trial data cached |
| Liver function test increased | 123 | 22.1 18.5–26.3ROR 22.6 · χ² 2,441 / p <1e-300 | 21.9 EB05 18.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Type 2 diabetes mellitus | 194 | 22.0 19.1–25.2ROR 22.7 · χ² 3,848 / p <1e-300 | 21.8 EB05 19.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 · ♀ 98% (drug 67%) · 95% clinician | no trial data cached |
| Ear infection | 148 | 21.3 18.2–25.0ROR 21.9 · χ² 2,835 / p <1e-300 | 21.2 EB05 18.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 · ♀ 96% (drug 67%) | no trial data cached |
| Liver injury | 126 | 19.9 16.8–23.7ROR 20.4 · χ² 2,237 / p <1e-300 | 19.8 EB05 17.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 · ♀ 100% (drug 67%) · 94% clinician | no trial data cached |
| Decreased immune responsiveness | 50 | 19.6 14.8–25.8ROR 19.7 · χ² 858 / p 6e-189 | 19.3 EB05 15.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 · ♀ 100% (drug 67%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypertension (high blood pressure) | 733 | 13.2 12.3–14.1ROR 15.1 · χ² 8,307 / p <1e-300 | 13.1 EB05 12.4 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 | no trial data cached |
| Headache | 686 | 4.2 3.9–4.5ROR 4.6 · χ² 1,701 / p <1e-300 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · ♀ 91% (drug 67%) | no trial data cached |
| Off label use (used outside approved label) | 644 | 2.8 2.6–3.0ROR 3.1 · χ² 790 / p 4e-174 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Pain | 608 | 3.8 3.5–4.1ROR 4.1 · χ² 1,267 / p 9e-278 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 89% (drug 67%) | no trial data cached |
| Fatigue (tiredness) | 605 | 3.0 2.8–3.2ROR 3.2 · χ² 816 / p 1e-179 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Hypersensitivity (allergic reaction) | 508 | 10.5 9.6–11.4ROR 11.4 · χ² 4,361 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.0 · ♀ 97% (drug 67%) | no trial data cached |
| Nausea | 450 | 2.2 2.0–2.4ROR 2.3 · χ² 294 / p 3e-66 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 425 | 24.6 22.5–27.0ROR 26.6 · χ² 9,583 / p <1e-300 | 24.5 EB05 22.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · ♀ 98% (drug 67%) | no trial data cached |
| Hepatic enzyme increased | 418 | 23.5 21.5–25.8ROR 25.4 · χ² 8,975 / p <1e-300 | 23.4 EB05 21.6 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 28.6 · ♀ 98% (drug 67%) · 92% clinician | no trial data cached |
| Joint swelling | 403 | 12.8 11.6–14.0ROR 13.7 · χ² 4,371 / p <1e-300 | 12.7 EB05 11.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · ♀ 98% (drug 67%) | no trial data cached |
| Rash | 390 | 3.4 3.1–3.8ROR 3.6 · χ² 681 / p 2e-150 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 88% (drug 67%) | no trial data cached |
| Dyspnoea (shortness of breath) | 380 | 2.6 2.3–2.8ROR 2.7 · χ² 369 / p 2e-82 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Diarrhoea (diarrhea) | 352 | 2.1 1.9–2.3ROR 2.2 · χ² 203 / p 2e-46 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Pyrexia (fever) | 351 | 3.9 3.5–4.3ROR 4.1 · χ² 753 / p 4e-166 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 89% (drug 67%) | no trial data cached |
| Prescribed overdose | 350 | 70.1 63.3–77.6ROR 74.8 · χ² 23,353 / p <1e-300 | 68.6 EB05 62.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 99.6 · ♀ 99% (drug 67%) · 93% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hypercholesterolaemia — n=216, PRR 87.9
- Prescribed overdose — n=350, PRR 70.1
- Immunodeficiency — n=257, PRR 67.6
- Helicobacter infection — n=175, PRR 66.5
- Joint dislocation — n=179, PRR 65.8
- Wound infection — n=170, PRR 60.5
- Coeliac disease — n=142, PRR 55.8
- Bursitis — n=170, PRR 54.4
- Joint range of motion decreased — n=175, PRR 50.5
- Folliculitis — n=135, PRR 50.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Clonidine ↔ Rebound hypertension / withdrawal syndrome.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Clonidine?
In FDA FAERS, the most frequently co-reported reaction terms for Clonidine are hypertension, headache, pain, fatigue, hypersensitivity, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Clonidine have an FDA boxed warning?
No. The FDA label retrieved for Clonidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clonidine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 99485427-a120-4fc7-bb61-25857d1900ec, effective 20251205; matched on
openfda.generic_name.exact:"CLONIDINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 603 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.