Drug Safety Information for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (Amlodipine besylate; atorvastatin calcium)

Safety-related Labeling Changes for CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM) Rx Drug: FDA Link

Adverse Drug Reactions for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM* (Amlodipine besylate; atorvastatin calcium)

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 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dizziness149
2Drug ineffective144
3Nausea136
4Malaise117
5Death117
6Fatigue*112
7Oedema peripheral109
8Pain103
9Headache103
10Hypertension98
11Dyspnoea96
12Asthenia88
13Blood glucose increased82
14Pain in extremity81
15Myalgia80
16Blood pressure increased80
17Fall79
18Pruritus77
19Cardiac failure congestive69
20Vomiting68

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

Top 10 Reasons for Taking AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypertension1542
2Blood cholesterol increased1157
3Product used for unknown indication684
4Blood pressure*264
5Dyslipidaemia102
6Cardiac disorder75
7Hyperlipidaemia54
8Blood cholesterol47
9Blood pressure abnormal41
10Ill-defined disorder38

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


Types of Adverse Events for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Total Reports Filed with FDA: 10202


Number of FDA Adverse Event Reports by Patient Age for AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Total Reports Filed with FDA: 10202*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amlodipine besylate; atorvastatin calcium (Caduet)

Charts are based on 10202 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 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM Reviews and Review Summary .

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.

Visit   DrugInformer.com more on AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM's side effects.