Drug Safety Information for DILACOR XR (Diltiazem hydrochloride)

Safety-related Labeling Changes for CARDIZEM (DILTIAZEM HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for CARDIZEM CD (DILTIAZEM HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for TIAZAC (DILTIAZEM HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for CARDIZEM LA (DILTIAZEM HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for DILACOR XR* (Diltiazem 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 DILACOR XR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea2761
2Nausea2341
3Dizziness*2004
4Fatigue*1823
5Atrial fibrillation1781
6Asthenia1740
7Drug ineffective1624
8Pain1544
9Diarrhoea1456
10Hypotension1350
11Vomiting1339
12Headache*1335
13Fall1324
14Cardiac failure congestive1317
15Pneumonia1312
16Chest pain1258
17Oedema peripheral1239
18Completed suicide1211
19Myocardial infarction1188
20Hypertension1116

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

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

Reason # of FDA Reports
1Product used for unknown indication18335
2Hypertension*18226
3Atrial fibrillation*3864
4Cardiac disorder3237
5Blood pressure*2480
6Angina pectoris*1082
7Blood pressure abnormal848
8Arrhythmia674
9Blood pressure increased636
10Heart rate increased515

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


Types of Adverse Events for DILACOR XR

Total Reports Filed with FDA: 189769


Number of FDA Adverse Event Reports by Patient Age for DILACOR XR

Total Reports Filed with FDA: 189769*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Diltiazem hydrochloride (Dilacor, Cardizem, Cartia, Cardizem cd, Diltiazem hcl, Diltiazem, Diltiazem hcl cd, Taztia, Matzim la, Diltzac, Diltiacem, Cardizem la, Dilacor xr, Dilt-cd, Tiazac, Cartia xt, Cardizem sr, Taztia xt)

Charts are based on 189769 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 DILACOR XR 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.