Oraqix Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Oraqix?

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.

What Are Side Effects of Oraqix?

Common side effects of Oraqix Periodontal Gel include:

application site reactions (pain, soreness, irritation, numbness, blisters, ulcers, swelling, or redness)
headache
changes in taste
nausea, and
fatigue

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Oraqix/h4>
The maximum recommended dose of Oraqix at one treatment session is 5 cartridges, i.e., 8.5g gel.

What Drugs, Substances, or Supplements Interact with Oraqix?

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.

Oraqix During Pregnancy or Breastfeeding

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.

Additional Information

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.

QUESTION

What causes tooth decay? See Answer

Oraqix Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe burning, stinging, or irritation where the medicine was applied;
swelling or redness;
sudden dizziness or drowsiness after medicine is applied;
confusion, blurred vision, ringing in your ears;
bruising or purple appearance of the skin; or
unusual sensations of temperature.

Common side effects may include:

mild burning where the medicine is applied;
itching, rash; or
changes in skin color where the medicine was applied.

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.

SLIDESHOW

Mouth Problems: TMJ, Canker Sores, Painful Gums and More See Slideshow

Oraqix Professional Information

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	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

DRUG INTERACTIONS

Other Local Anesthetics Or Agents Structurally Related To Local Anesthetics

Oraqix should be used with caution in combination with dental injection anesthesia, other local anesthetics, or agents structurally related to local anesthetics, e.g., Class 1 antiarrhythmics such as tocainide and mexiletine, as the toxic effects of these drugs are likely to be additive and potentially synergistic.

Drugs That May Cause Methemoglobinemia When Used With ORAQIX

Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics:

Examples Of Drugs Associated With Methemoglobinemia

Class	Examples
Nitrates/Nitrites	nitric oxide, nitroglycerin, nitroprusside, nitrous oxide
Local anesthetics	articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine
Antineoplastic agents	cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase
Antibiotics	dapsone, nitrofurantoin, para- aminosalicylic acid, sulfonamides
Antimalarials	chloroquine, primaquine
Anticonvulsants	Phenobarbital, phenytoin, sodium valproate
Other drugs	acetaminophen, metoclopramide, quinine, sulfasalazine

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