What are the possible side effects of Oragard B?
Oragard B used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a). This condition may occur after only one use of Oragard B or after several uses.
Signs and symptoms may occur within minutes or up to 2 hours after using Oragard B in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:
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a headache, tiredness, confusion;
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fast heartbeats;
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feeling light-headed or short of breath; and
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pale, blue, or gray appearance of your skin, lips, or fingernails.
Get emergency medical help if you have signs of an allergic reaction to Oragard B: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
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severe burning, stinging, or sensitivity where the medicine is applied;
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swelling, warmth, or redness; or
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oozing, blistering, or any signs of infection.
Common Oragard B side effects may include:
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mild stinging, burning, or itching where the medicine is applied;
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skin tenderness or redness; or
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dry white flakes 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.
Side effects of Oragard B in details
Applies to Oragard B: cream, film, gel/jelly, gum, liquid, lotion, lozenge/troche, ointment, paste, powder for suspension, solution, spray, swab, tablet disintegrating
Other dosage forms:
- topical application cream, topical application gel/jelly, topical application liquid, topical application ointment, topical application spray, topical application wax
In addition to its needed effects, some unwanted effects may be caused by Oragard B (the active ingredient contained in Gelato
Topical Anesthetic Gel). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Oragard B:
Incidence not known:
- Headache
- high fever
- nausea
- vomiting
- worsening of pain, redness, swelling, or irritation in or around the mouth
What is the most important information I should know about Oragard B?
- Do not use Oragard B aerosol spray on severe burns or deep puncture wounds.
- If your symptoms do not improve within 7 days or if they become worse, check with your doctor.
- Do not exceed the recommended dose or use Oragard B aerosol spray for longer than 7 days without checking with your doctor.
- Oragard B aerosol spray is extremely flammable. Do not store or use near an open flame or while smoking.
- The contents of this container are under pressure. Do not burn or puncture the container, even if it appears to be empty.
- Do not inhale the contents of this container. Inhaling the contents of this container may be harmful or fatal.
- Use of Oragard B aerosol spray is not recommended in CHILDREN younger than 2 years of age without first checking with your doctor. Safety and effectiveness have not been established.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Oragard B aerosol spray, discuss with your doctor the benefits and risks of using Oragard B aerosol spray during pregnancy. It is unknown if Oragard B aerosol spray is excreted in breast milk. If you are or will be breast-feeding while you are using Oragard B aerosol spray, check with your doctor or pharmacist to discuss the risks to your baby.
Oragard B contraindications
Oragard B is contraindicated in patients sensitive to Oragard B. This medication should not be applied in the external auditory canal if there is a perforated eardrum or ear discharge.
References
- DTP/NCI. "benzocaine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "DEXTRAN SULFATE: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "BENZOCAINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Oragard B are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Oragard B. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology