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Oraqix (Lidocaine / Prilocaine Periodontal) - Side Effects and Adverse Reactions



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 1
(N = 391)
n (%)
Placebo gel
(N = 168)
n (%)
Lidocaine injection
(N = 170)
n (%)
Muscular-Skeletal System Disorders
1(0) 2(1)
Arthralgia and/or Arthropathy 1(0) 1(1)
Central & Peripheral Nervous System
Headache 8(2) 3(2) 5(3)
Dizziness 1(0) 1(1) 1(1)
Special Senses Other, Disorders
Taste Perversion 2
8(2) 1(1)
Gastro-Intestinal System Disorders
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 3
Anesthesia Local
Application Site Reaction 4 52(13) 20(12)

1 in a cross-over study, 170 subjects received either Oraqix or lidocaine injection 2% in each test period
2 includes complaints of bad or bitter taste lasting for up to 4 hours after administration of Oraqix
3 i.e. symptoms in the oral cavity
4 includes pain, soreness, irritation, numbness, ulcerations, vesicles, edema, abscess and/or redness in the treated area

Drug label data at the top of this Page last updated: 2012-08-20

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