What are the possible side effects of Ora film?
Ora film 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 Ora film or after several uses.
Signs and symptoms may occur within minutes or up to 2 hours after using Ora film 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 Ora film: 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 Ora film 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 Ora film in details
Applies to Ora film: 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 Ora film (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 Ora film:
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 Ora film?
- Do not use Ora film 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 Ora film aerosol spray for longer than 7 days without checking with your doctor.
- Ora film 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 Ora film 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 Ora film aerosol spray, discuss with your doctor the benefits and risks of using Ora film aerosol spray during pregnancy. It is unknown if Ora film aerosol spray is excreted in breast milk. If you are or will be breast-feeding while you are using Ora film aerosol spray, check with your doctor or pharmacist to discuss the risks to your baby.
Ora film contraindications
Ora film is contraindicated in patients sensitive to Ora film. 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 Ora film 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 Ora film. 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