Drug Safety Information for MODURETIC 5-50 (Amiloride hydrochloride; hydrochlorothiazide)

Adverse Drug Reactions for MODURETIC 5-50* (Amiloride hydrochloride; hydrochlorothiazide)

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 MODURETIC 5-50
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Hyponatraemia119
2Vomiting*68
3Dyspnoea62
4Nausea60
5Confusional state54
6Drug interaction54
7Hypertension54
8Fall54
9Asthenia51
10Dizziness48
11Diarrhoea47
12Hyperkalaemia46
13Malaise41
14Anaemia40
15Drug ineffective37
16Oedema peripheral34
17Blood pressure increased34
18Somnolence33
19Abdominal pain upper33
20Fatigue32

* This side effect also appears in "Top 10 Side Effects of MODURETIC 5-50 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking MODURETIC 5-50
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypertension1357
2Product used for unknown indication403
3Diuretic therapy140
4Essential hypertension108
5Ill-defined disorder56
6Oedema56
7Oedema peripheral39
8Cardiac failure congestive38
9Swelling30
10Endolymphatic hydrops30

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


Types of Adverse Events for MODURETIC 5-50

Total Reports Filed with FDA: 5523


Number of FDA Adverse Event Reports by Patient Age for MODURETIC 5-50

Total Reports Filed with FDA: 5523*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amiloride hydrochloride; hydrochlorothiazide (Moduretic 5-50, Hydro-ride)

Charts are based on 5523 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 MODURETIC 5-50 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.