Drug Safety Information for LIDOCAINE (Lidocaine)

Safety-related Labeling Changes for XYLOCAINE W/ EPINEPHRINE (LIDOCAINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER (LIDOCAINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER (LIDOCAINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER (LIDOCAINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER (LIDOCAINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for EMLA (LIDOCAINE; PRILOCAINE) Rx Drug: FDA Link

Safety-related Labeling Changes for LIDODERM (LIDOCAINE) Rx Drug: FDA Link

Safety-related Labeling Changes for XYLOCAINE DENTAL (LIDOCAINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for ORAQIX (LIDOCAINE; PRILOCAINE) Rx Drug: FDA Link

Safety-related Labeling Changes for SYNERA (LIDOCAINE; TETRACAINE) Rx Drug: FDA Link

Safety-related Labeling Changes for PLIAGLIS (LIDOCAINE; TETRACAINE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZINGO (LIDOCAINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for AKTEN (LIDOCAINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for LIDOCAINE* (Lidocaine)

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 LIDOCAINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*1171
2Nausea*817
3Anxiety708
4Dyspnoea607
5Renal failure558
6Headache*550
7Injury541
8Vomiting540
9Drug ineffective*537
10Fatigue*522
11Dizziness516
12Hypotension493
13Asthenia469
14Depression442
15Death439
16Diarrhoea432
17Pyrexia427
18Back pain*422
19Unevaluable event408
20Arthralgia405

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

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

Reason # of FDA Reports
1Product used for unknown indication5897
2Pain3318
3Local anaesthesia2039
4Anaesthesia1664
5Back pain*938
6Epidural anaesthesia487
7Nerve block447
8Arthralgia382
9Neuralgia294
10Analgesic therapy285

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


Types of Adverse Events for LIDOCAINE

Total Reports Filed with FDA: 75246


Number of FDA Adverse Event Reports by Patient Age for LIDOCAINE

Total Reports Filed with FDA: 75246*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lidocaine (Lidocaine 5%, Xylocaine polyamp, Lidoderm 5, Dentipatch, Lidocaine, Xylocard, Anamantle hc, Anecream 5, Anestafoam, Burn relief, Lmx5, Alphacaine, Numb nuts, Recticare, Curacaine, Dr. numb, Hush anesthetic, Promescent, Derma numb, Xylocitin, Sole serum, Ela-max, Solarcaine, Lmx4, Xylocaine, Instillagel, Lidocare mist, Anecream, Lignospan, Licodaine, Vagisil, Lmx 5, Lidoderm)

Charts are based on 75246 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 LIDOCAINE 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.