Oraqix

Oraqix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Oraqix (lidocaine and prilocaine) Periodontal Gel is an amide local anesthetic used for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. Common side effects include pain, soreness, irritation, numbness, blisters, ulcers, swelling and/or redness in the treated area.

The maximum recommended dose of Oraqix at one treatment session is 5 cartridges, i.e., 8.5g gel. Oraqix may interact with other local anesthetics, antiarrhythmics, sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine. Tell your doctor or dentist all medications and supplements you use. During pregnancy, Oraqix should be used only if prescribed. Lidocaine and, possibly, prilocaine pass into breast milk. Exercise caution when Oraqix is administered to nursing women. Consult your doctor before breastfeeding.

Our Oraqix (lidocaine and prilocaine) Periodontal Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Oraqix FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Although no major differences in adverse events between Oraqix and placebo-treated subjects were observed, all patients in the placebo-controlled studies received either Oraqix or a placebo gel (consisting of the vehicle in Oraqix without lidocaine or prilocaine). Therefore, it is not possible to determine if adverse events in each treatment group were attributable to the inactive ingredients comprising the Oraqix or vehicle or if adverse event rates were higher than expected background rates. Therefore, a causal relationship between the reported adverse reactions and Oraqix could neither be established nor ruled out.

Following SRP treatment with Oraqix in 391 patients, the most frequent adverse events were local reactions in the oral cavity (see following table). These events, which occurred in approximately 15% of patients, included pain, soreness, irritation, numbness, vesicles, ulcerations, edema and/or redness in the treated area. Of the 391 patients treated with Oraqix, five developed ulcerative lesions and two developed vesicles of mild to moderate severity near the site of SRP. In addition, ulcerative lesions in or near the treated area were also reported for three out of 168 patients who received placebo. Other symptoms reported in more than one patient were headache, taste perversion, nausea, fatigue, flu, respiratory infection, musculoskeletal pain and accident/injury.

Table 1: Number (percent) of patients with adverse events occurring in more than one patient in any of the treatment groups. Each patient is counted only once per adverse event. The occurrence in a single patient is included in this table if the same symptom has been seen in at least one patient in another group.

System Organ Class Preferred Term Oraqix gel*
(N =391)
n (%)
Placebo gel
(N =168)
n (%)
Lidocaine injection*
(N =170)
n (%)
Muscular-Skeletal System Disorders
Myalgia 1 (0) 2 (1)  
Arthralgia and/or Arthropathy 1 (0) 1 (1)  
Central & Peripheral Nervous System
Disorders      
Headache 8 (2) 3 (2) 5 (3)
Dizziness 1 (0) 1 (1) 1 (1)
Special Senses Other, Disorders
Taste Perversion1 8 (2) 1 (1)  
Gastro-Intestinal System Disorders
Nausea 3 (1) 1 (1)  
Respiratory System
Disorders Respiratory Infection 2 (1) 1 (1)  
Rhinitis 2 (1)    
Body as a whole-General Disorders
Accident and/or Injury 2 (1) 2 (1)  
Fatigue 3 (1) 2 (1)  
Flu?Like Disorder 2 (1)    
Pain (remote from application site) 1 (0) 1 (1) 1 (1)
Application Site Disorders**
Anesthesia Local 2(1)    
Application Site Reaction*** 52 (13) 20 (12)  
1includes complaints of bad or bitter taste lasting for up to 4 hours after administration of Oraqix
* in a cross-over study, 170 subjects received either Oraqix or lidocaine injection 2% in each test period
** i.e. symptoms in the oral cavity
*** includes pain, soreness, irritation, numbness, ulcerations, vesicles, edema, abscess and/or redness in the treated area

Read the entire FDA prescribing information for Oraqix (Lidocaine and Prilocaine Periodontal Gel) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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