Drug Safety Information for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (Hydrochlorothiazide; spironolactone)

Safety-related Labeling Changes for ALDACTAZIDE (HYDROCHLOROTHIAZIDE; SPIRONOLACTONE) Rx Drug: FDA Link

Adverse Drug Reactions for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE* (Hydrochlorothiazide; spironolactone)

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 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea42
2Renal failure acute42
3Nausea40
4Dyspnoea37
5Fatigue37
6Fall35
7Drug ineffective35
8Confusional state32
9Asthenia31
10Dizziness29
11Pain29
12Pain in extremity28
13Oedema peripheral28
14Hyponatraemia27
15Malaise26
16Renal failure26
17Myocardial infarction26
18Vomiting24
19Drug interaction23
20Arthralgia23

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

Top 10 Reasons for Taking SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypertension*424
2Product used for unknown indication312
3Oedema115
4Blood pressure66
5Ill-defined disorder55
6Oedema peripheral37
7Diuretic therapy34
8Essential hypertension23
9Cardiac disorder20
10Fluid retention17

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


Types of Adverse Events for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

Total Reports Filed with FDA: 3851


Number of FDA Adverse Event Reports by Patient Age for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

Total Reports Filed with FDA: 3851*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydrochlorothiazide; spironolactone (Aldactazide)

Charts are based on 3851 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 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE 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.