Drug Safety Information for LANSOPRAZOLE (Lansoprazole)

FDA Safety-related Labeling Changes for PREVACID (LANSOPRAZOLE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for PREVACID 24 HR (LANSOPRAZOLE) Over-the-counter Drug: Safety Information Link

Adverse Drug Reactions for LANSOPRAZOLE* (Lansoprazole)

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 LANSOPRAZOLE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*3831
2Diarrhoea*3063
3Dyspnoea2881
4Vomiting2778
5Pain*2428
6Fatigue2395
7Drug ineffective2358
8Dizziness*2331
9Headache*2275
10Pyrexia2236
11Malaise2002
12Asthenia1935
13Pneumonia1831
14Abdominal pain1768
15Chest pain1731
16Anaemia1730
17Fall1723
18Arthralgia1659
19Decreased appetite1608
20Depression*1592

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

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

Reason # of FDA Reports
1Gastrooesophageal reflux disease*26015
2Product used for unknown indication25532
3Prophylaxis5381
4Dyspepsia*4913
5Gastric ulcer*3207
6Prophylaxis against gastrointestinal ulcer2712
7Gastritis*2559
8Gastric disorder2221
9Abdominal discomfort1033
10Ulcer*969

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


Types of Adverse Events for LANSOPRAZOLE

Total Reports Filed with FDA: 301676


Number of FDA Adverse Event Reports by Patient Age for LANSOPRAZOLE

Total Reports Filed with FDA: 301676*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lansoprazole (Lanzor, Ogast, Agopton, Takepron, Prevacid, Lansoprazole , Careone lansoprazole, Leader lansoprazole, Monolitum, Sunmark lansoprazole, Topcare lansoprazole, Prevacid solutab, Prevacid iv, Pro ulco, Opiren, Zoton, Ogastro, Prevacid 24 hr, Dexlansoprazole, Lansoprazole)

Charts are based on 301676 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 LANSOPRAZOLE 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.