Drug Safety Information for AMILORIDE HYDROCHLORIDE (Amiloride hydrochloride)

Adverse Drug Reactions for AMILORIDE HYDROCHLORIDE* (Amiloride 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 AMILORIDE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea116
2Diarrhoea105
3Vomiting92
4Dyspnoea89
5Renal failure acute88
6Drug interaction76
7Abdominal pain75
8Hyponatraemia72
9Fall69
10Dizziness68
11Asthenia68
12Pyrexia68
13Hyperkalaemia67
14Fatigue63
15Dehydration59
16Drug ineffective58
17Oedema peripheral58
18Hypotension58
19Confusional state56
20Headache56

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

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

Reason # of FDA Reports
1Hypertension827
2Product used for unknown indication675
3Diuretic therapy180
4Oedema92
5Blood pressure75
6Fluid retention63
7Cardiac failure congestive50
8Polyuria47
9Renal disorder44
10Hypokalaemia42

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


Types of Adverse Events for AMILORIDE HYDROCHLORIDE

Total Reports Filed with FDA: 8676


Number of FDA Adverse Event Reports by Patient Age for AMILORIDE HYDROCHLORIDE

Total Reports Filed with FDA: 8676*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amiloride hydrochloride (Amiloride, Amilorida, Midamor)

Charts are based on 8676 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 AMILORIDE HYDROCHLORIDE 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.