Drug Safety Information for CATAPRES (Clonidine hydrochloride)

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

Adverse Drug Reactions for CATAPRES* (Clonidine hydrochloride)

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 CATAPRES
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea195
2Hypertension194
3Pain181
4Dyspnoea167
5Blood pressure increased162
6Drug ineffective160
7Cardiac failure congestive159
8Headache159
9Cerebrovascular accident156
10Dizziness*141
11Chest pain141
12Vomiting141
13Anxiety*140
14Asthenia134
15Myocardial infarction126
16Hypotension121
17Fatigue*118
18Diarrhoea111
19Fall104
20Oedema peripheral104

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

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

Reason # of FDA Reports
1Hypertension*2332
2Product used for unknown indication1458
3Blood pressure*259
4Attention deficit/hyperactivity disorder*224
5Blood pressure increased201
6Blood pressure abnormal143
7Essential hypertension119
8Pain*58
9Cardiac disorder51
10Hot flush*48

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


Types of Adverse Events for CATAPRES

Total Reports Filed with FDA: 18156


Number of FDA Adverse Event Reports by Patient Age for CATAPRES

Total Reports Filed with FDA: 18156*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clonidine hydrochloride (Clonidina, Jenloga, Catapres, Duraclon, Kapvay)

Charts are based on 18156 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 CATAPRES 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.