Drug Safety Information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (Hydrochlorothiazide; losartan potassium)

Safety-related Labeling Changes for HYZAAR (HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM) Rx Drug: FDA Link

Adverse Drug Reactions for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE* (Hydrochlorothiazide; losartan potassium)

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 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*530
2Drug ineffective431
3Dizziness*414
4Dyspnoea379
5Fatigue*375
6Headache*361
7Pain333
8Diarrhoea332
9Asthenia326
10Vomiting303
11Myocardial infarction298
12Hypertension274
13Arthralgia266
14Blood glucose increased253
15Chest pain239
16Blood pressure increased238
17Fall234
18Pruritus232
19Pain in extremity225
20Malaise225

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

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

Reason # of FDA Reports
1Hypertension*8092
2Product used for unknown indication2468
3Blood pressure*665
4Essential hypertension*304
5Blood pressure abnormal258
6Blood pressure increased166
7Cardiac disorder62
8Ill-defined disorder53
9Blood cholesterol increased37
10Oedema37

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


Types of Adverse Events for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Total Reports Filed with FDA: 37716


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

Total Reports Filed with FDA: 37716*


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

Charts are based on 37716 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.

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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.