Drug Safety Information for LOSARTAN POTASSIUM (Losartan potassium)

Safety Concern Raised for LOSARTAN (LOSARTAN POTASSIUM) Rx Drug: Safety Information Link

NDMA contamination voluntary recalls of some products

FDA Safety-related Labeling Changes for COZAAR (LOSARTAN POTASSIUM) Rx Drug: Safety Information Link

Adverse Drug Reactions for LOSARTAN POTASSIUM* (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
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea2630
2Nausea2569
3Drug ineffective2554
4Fatigue*2344
5Dizziness*2320
6Diarrhoea2040
7Headache*1937
8Pain*1784
9Asthenia1682
10Vomiting1563
11Hypertension1522
12Malaise1507
13Fall1462
14Arthralgia*1439
15Pain in extremity1399
16Cough*1361
17Blood pressure increased1267
18Chest pain1203
19Weight decreased1187
20Pneumonia1174

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

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

Reason # of FDA Reports
1Hypertension*46455
2Product used for unknown indication21473
3Blood pressure*5385
4Blood pressure abnormal2793
5Cardiac disorder1414
6Blood pressure increased*1060
7Cardiac failure congestive762
8Essential hypertension609
9Cardiac failure522
10Renal disorder331

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


Types of Adverse Events for LOSARTAN POTASSIUM

Total Reports Filed with FDA: 201879


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

Total Reports Filed with FDA: 201879*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Losartan potassium (Lozartan, Losortan potassium, Losartan potatssium, Losartan, Losartan potassium, Cozaar)

Charts are based on 201879 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 LOSARTAN POTASSIUM 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.