Oraqix Side Effects
Please note - some side effects for Oraqix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
|
For the professional
|
For the professional
Oraqix
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. 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.
| System Organ Class Preferred Team |
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 Perversion† | 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) | |
Allergic Reactions
Allergic and anaphylactic reactions associated with lidocaine or prilocaine can occur. They may be characterized by urticaria, angioedema, bronchospasm, and shock. If they occur, they should be managed by conventional means.
TopDisclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
