Drug Safety Information for LIDOCAINE Hydrochloride VISCOUS (Lidocaine hydrochloride)
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 XYLOCAINE DENTAL (LIDOCAINE HYDROCHLORIDE) Discontinued 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 Hydrochloride VISCOUS* (Lidocaine hydrochloride)
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 Hydrochloride VISCOUS
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Dyspnoea | 73 |
2 | Nausea | 73 |
3 | Pain | 71 |
4 | Hypotension | 63 |
5 | Dizziness | 62 |
6 | Convulsion | 54 |
7 | Toxicity to various agents | 52 |
8 | Cardiac arrest | 50 |
9 | Anaemia | 45 |
10 | Fatigue | 44 |
11 | Headache | 43 |
12 | Pyrexia | 42 |
13 | Vomiting | 40 |
14 | Anxiety | 39 |
15 | Asthenia | 39 |
16 | Anaphylactic reaction | 38 |
17 | Tachycardia | 37 |
18 | Decreased appetite | 37 |
19 | Abdominal pain | 36 |
20 | Hypertension | 36 |
* This side effect also appears in "Top 10 Side Effects of LIDOCAINE Hydrochloride VISCOUS " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking LIDOCAINE Hydrochloride VISCOUS
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Product used for unknown indication | 901 |
2 | Local anaesthesia | 479 |
3 | Anaesthesia | 291 |
4 | Pain | 71 |
5 | Analgesic therapy | 65 |
6 | Nerve block | 63 |
7 | Surgery | 57 |
8 | Epidural anaesthesia | 52 |
9 | General anaesthesia | 52 |
10 | Endoscopy | 46 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for LIDOCAINE Hydrochloride VISCOUS
Total Reports Filed with FDA: 7955
Number of FDA Adverse Event Reports by Patient Age for LIDOCAINE Hydrochloride VISCOUS
Total Reports Filed with FDA: 7955*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lidocaine hydrochloride (Lidocaina, Lidopen, Xylocaine dental, Pediatric lta kit, Regenecare ha, Afterburn, Bio-scriptives lidum, Burn jel, Burn jel plus, Burn mist, Lidocoll, Xylocaine-mpf, Solarcaine cool aloe, North burn relief, Publix burn relief, Rite aid burn relief, Unburn, Alocane, Exsel aloe, Ez pain relieving, Lidostat, Xolido, Anesthetic, Xylocaine viscous, Glydo, Lidocaine viscous, Laryng-o-jet kit, Predator, Lignocaine, Laryng-o-jet, Lta ii kit, Anestacon, Zingo, Akten)
Charts are based on 7955 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.
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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.