Drug Safety Information for LEVAQUIN (Levofloxacin)

Safety-related Labeling Changes for LEVAQUIN (LEVOFLOXACIN) Rx Drug: FDA Link

Risk of mitral and aortic regurgitation Evaluating

Adverse Drug Reactions for LEVAQUIN* (Levofloxacin)

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 LEVAQUIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Arthralgia*2441
2Pain*2276
3Tendon rupture2004
4Pain in extremity*1975
5Nausea*1916
6Dyspnoea1910
7Tendonitis1846
8Pyrexia1643
9Pneumonia1576
10Asthenia1571
11Anxiety*1561
12Diarrhoea1462
13Fatigue1443
14Dizziness*1416
15Insomnia*1286
16Vomiting1250
17Headache*1181
18Rotator cuff syndrome1129
19Gait disturbance1097
20Depression*1089

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

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

Reason # of FDA Reports
1Product used for unknown indication16203
2Sinusitis*8780
3Pneumonia*7259
4Bronchitis*6896
5Urinary tract infection*5369
6Infection*2527
7Bacterial infection2302
8Infection prophylaxis1865
9Upper respiratory tract infection*1721
10Prophylaxis1668

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


Types of Adverse Events for LEVAQUIN

Total Reports Filed with FDA: 195777


Number of FDA Adverse Event Reports by Patient Age for LEVAQUIN

Total Reports Filed with FDA: 195777*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Levofloxacin (Ofloxacine, Iquix, Levaquin, Quixin, Levofloxacin)

Charts are based on 195777 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 LEVAQUIN 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.