Drug Safety Information for LOZOL (Indapamide)

FDA Safety-related Labeling Changes for LOZOL (INDAPAMIDE) Brand name discontinued; available as generic: Safety Information Link

Adverse Drug Reactions for LOZOL* (Indapamide)

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 LOZOL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Hyponatraemia364
2Nausea*312
3Dizziness*262
4Fall240
5Dyspnoea236
6Vomiting236
7Diarrhoea233
8Asthenia226
9Malaise218
10Hypokalaemia210
11Confusional state206
12Headache200
13Renal failure acute190
14Fatigue185
15Hypertension175
16Drug interaction171
17Blood pressure increased166
18Oedema peripheral166
19Pain166
20Drug ineffective155

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

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

Reason # of FDA Reports
1Hypertension5149
2Product used for unknown indication2221
3Blood pressure*446
4Diuretic therapy321
5Essential hypertension286
6Fluid retention136
7Blood pressure abnormal126
8Oedema118
9Blood pressure increased90
10Ill-defined disorder73

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


Types of Adverse Events for LOZOL

Total Reports Filed with FDA: 25074


Number of FDA Adverse Event Reports by Patient Age for LOZOL

Total Reports Filed with FDA: 25074*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Indapamide (Indapamide, Natrilix, Natrilix sr, Lozol)

Charts are based on 25074 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 LOZOL 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.