Drug Safety Information for CLONIDINE (Clonidine)

FDA Safety-related Labeling Changes for KAPVAY (CLONIDINE HYDROCHLORIDE EXTENDED RELEASE) Rx Drug: Safety Information Link

Adverse Drug Reactions for CLONIDINE* (Clonidine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CLONIDINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea1235
2Drug ineffective1209
3Hypertension1156
4Pain1066
5Dyspnoea1061
6Blood pressure increased993
7Headache*959
8Vomiting904
9Dizziness*895
10Fatigue*851
11Asthenia827
12Hypotension781
13Anxiety*715
14Diarrhoea705
15Oedema peripheral603
16Chest pain584
17Fall584
18Insomnia*562
19Depression*554
20Cerebrovascular accident537

* This side effect also appears in "Top 10 Side Effects of CLONIDINE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CLONIDINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypertension*13809
2Product used for unknown indication9049
3Blood pressure*1628
4Blood pressure abnormal785
5Blood pressure increased652
6Pain*496
7Attention deficit/hyperactivity disorder*482
8Hot flush*411
9Insomnia*357
10Sleep disorder206

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CLONIDINE

Total Reports Filed with FDA: 104832


Number of FDA Adverse Event Reports by Patient Age for CLONIDINE

Total Reports Filed with FDA: 104832*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clonidine (Isoglaucon, Catapresan, Nexiclon, Catapressan, Chlophazolin, Nexiclon xr, Dixarit, Clonidine, Catapres-tts-1, Catapres-tts-3, Catapres-tts-2)

Charts are based on 104832 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CLONIDINE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.