Drug Safety Information for LANTUS (Insulin glargine recombinant)

Safety-related Labeling Changes for LANTUS (INSULIN GLARGINE) Rx Drug: FDA Link

Safety-related Labeling Changes for TOUJEO MAX SOLOSTAR (INSULIN GLARGINE RECOMBINANT) Rx Drug: FDA Link

Adverse Drug Reactions for LANTUS* (Insulin glargine recombinant)

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 LANTUS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood glucose increased10449
2Nausea3866
3Blood glucose decreased3543
4Hypoglycaemia2934
5Weight decreased2773
6Drug ineffective2437
7Device malfunction2226
8Product quality issue2221
9Vomiting2174
10Dyspnoea2133
11Hyperglycaemia2122
12Dizziness2075
13Malaise2042
14Fall1933
15Fatigue1902
16Diarrhoea1826
17Asthenia1795
18Decreased appetite1709
19Cerebrovascular accident1687
20Pain1646

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

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

Reason # of FDA Reports
1Type 2 diabetes mellitus40167
2Diabetes mellitus*35002
3Product used for unknown indication17321
4Type 1 diabetes mellitus9540
5Insulin-requiring type 2 diabetes mellitus1098
6Blood glucose increased303
7Hyperglycaemia197
8Blood glucose abnormal186
9Suicide attempt104
10Diabetes mellitus inadequate control87

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


Types of Adverse Events for LANTUS

Total Reports Filed with FDA: 238029


Number of FDA Adverse Event Reports by Patient Age for LANTUS

Total Reports Filed with FDA: 238029*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Insulin glargine recombinant (Toujeo solostar, Lantus, Lantus solostar)

Charts are based on 238029 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 LANTUS Reviews and Review Summary .

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.

Visit   DrugInformer.com more on LANTUS's side effects.