Drug Safety Information for APRESOLINE (Hydralazine hydrochloride)

Safety-related Labeling Changes for BIDIL (HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE) Rx Drug: FDA Link

Adverse Drug Reactions for APRESOLINE* (Hydralazine 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 APRESOLINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Cardiac failure congestive676
2Dyspnoea621
3Nausea503
4Hypertension476
5Asthenia413
6Pain*404
7Fatigue393
8Dizziness389
9Anaemia387
10Renal failure366
11Vomiting365
12Renal failure acute365
13Hypotension362
14Diarrhoea352
15Pneumonia349
16Myocardial infarction315
17Oedema peripheral306
18Cerebrovascular accident299
19Drug ineffective298
20Headache*294

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

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

Reason # of FDA Reports
1Product used for unknown indication6020
2Hypertension*5634
3Blood pressure798
4Blood pressure abnormal388
5Cardiac disorder251
6Blood pressure increased137
7Gestational hypertension92
8Cardiac failure congestive83
9Pre-eclampsia81
10Pruritus76

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


Types of Adverse Events for APRESOLINE

Total Reports Filed with FDA: 46199


Number of FDA Adverse Event Reports by Patient Age for APRESOLINE

Total Reports Filed with FDA: 46199*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydralazine hydrochloride (Dralzine, Hidralazina, Hydralazine, Apresoline)

Charts are based on 46199 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 APRESOLINE 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.