Drug Safety Information for NORMODYNE (Labetalol hydrochloride)

Adverse Drug Reactions for NORMODYNE* (Labetalol 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 NORMODYNE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Hypertension383
2Nausea*331
3Dyspnoea308
4Pain301
5Fatigue*256
6Hypotension250
7Headache243
8Drug ineffective243
9Asthenia221
10Anxiety220
11Dizziness*219
12Diarrhoea218
13Vomiting211
14Cardiac failure congestive205
15Blood pressure increased205
16Cerebrovascular accident205
17Myocardial infarction198
18Renal failure197
19Anaemia194
20Renal failure acute178

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

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

Reason # of FDA Reports
1Hypertension*4796
2Product used for unknown indication3102
3Blood pressure*559
4Blood pressure increased199
5Blood pressure abnormal165
6Essential hypertension157
7Pre-eclampsia100
8Gestational hypertension82
9Malignant hypertension70
10Hypertensive crisis59

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


Types of Adverse Events for NORMODYNE

Total Reports Filed with FDA: 31847


Number of FDA Adverse Event Reports by Patient Age for NORMODYNE

Total Reports Filed with FDA: 31847*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Labetalol hydrochloride (Apo-labetalol, Labetalol, Presolol, Labetalol hcl, Albetol, Labetolol, Trandate, Normodyne, Apo labetalol)

Charts are based on 31847 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 NORMODYNE 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.