Drug Safety Information for CANDESARTAN CILEXETIL (Candesartan cilexetil)

Safety-related Labeling Changes for ATACAND (CANDESARTAN CILEXETIL) Rx Drug: FDA Link

Safety-related Labeling Changes for ATACAND HCT (CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE) Rx Drug: FDA Link

Adverse Drug Reactions for CANDESARTAN CILEXETIL* (Candesartan cilexetil)

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 CANDESARTAN CILEXETIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea873
2Dizziness*848
3Malaise838
4Nausea807
5Renal failure acute795
6Drug ineffective795
7Hypertension794
8Diarrhoea742
9Drug interaction717
10Fatigue*688
11Blood pressure increased656
12Fall652
13Pyrexia645
14Anaemia613
15Asthenia602
16Vomiting600
17Hypotension599
18Headache*598
19Decreased appetite518
20Blood creatinine increased509

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

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

Reason # of FDA Reports
1Hypertension*23532
2Product used for unknown indication6452
3Essential hypertension1045
4Blood pressure*1015
5Blood pressure abnormal614
6Cardiac failure600
7Blood pressure increased345
8Ill-defined disorder272
9Cardiac failure chronic255
10Renal disorder209

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


Types of Adverse Events for CANDESARTAN CILEXETIL

Total Reports Filed with FDA: 89045


Number of FDA Adverse Event Reports by Patient Age for CANDESARTAN CILEXETIL

Total Reports Filed with FDA: 89045*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Candesartan cilexetil (Parapres, Amias, Tcv-116, Kenzen, Blopress, Atacand)

Charts are based on 89045 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.

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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.