Slideshows Images Quizzes

Oravig

Last reviewed on RxList: 8/17/2017
Oravig Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/17/2017

Oravig (miconazole) Buccal Tablets is an antifungal medication used to treat candida (yeast) infections inside the mouth. Common side effects of Oravig include:

  • mouth discomfort
  • sores
  • decreased sense of taste
  • unusual or unpleasant taste
  • irritation/pain in the mouth or tongue
  • nausea vomiting diarrhea abdominal pain
  • headache
  • cough
  • dry mouth
  • tired feeling.
The recommended dosing schedule for Oravig is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days. Oravig may interact with other drugs. Tell your doctor or dentist all medications and supplements you use. During pregnancy, Oravig should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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.

Oravig Consumer Information

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

Call your doctor at once if you have a serious side effect such as:

  • severe burning or pain in your mouth;
  • new sores in your mouth or on your tongue;
  • tooth problems;
  • pain or swelling in your gums; or
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Less serious side effects may include:

  • decreased sense of taste;
  • unusual or unpleasant taste;
  • mild pain or discomfort in your mouth or tongue;
  • cough, dry mouth;
  • nausea, vomiting, diarrhea;
  • headache; or
  • tired feeling.

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.

Read the entire detailed patient monograph for Oravig (Miconazole Buccal Tablets)

Oravig Professional Information

SIDE EFFECTS

The following serious adverse drug reactions are discussed in detail in other sections oflabeling:

  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in clinical practice.

The overall safety of ORAVIG was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects.

HIV Infected Patients

Two trials were conducted in immunocompromised HIV-infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 ORAVIG, 287 control) and one non-comparative trial (N = 25).

In the randomized, double blind trial (Study 1), 290 HIV infected subjects used ORAVIG once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are pre­sented in Table 1.

Table 1 : Adverse Reactions (Treatment-Emergent) Occurring in a ≥ 2% of HIV-Infected Patients in the Controlled Clinical Trial

Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG
N = 290 (%)
Clotrimazole troches
N = 287 (%)
Patients with any adverse reaction duringthe study 158 (54.5) 146 (50.9)
Gastrointestinal disorders 25.9 23.7
  Diarrhea 9 8
  Nausea 6.6 7.7
  Vomiting 3.8 3.1
  Dry mouth 2.8 1.7
  Abdominal pain upper 1.7 2.8
Infections and infestations 15.9 17.1
  Upper respiratory infection 2.1 2.4
  Gastroenteritis 1.4 2.8
Nervous system disorders 13.1 8.4
  Headache 7.6 6.6
  Ageusia 2.4 0.3
Blood and lymphatic disorders 6.9 8.4
  Anemia 2.8 1.7
  Lymphopenia 1.7 2.1
  Neutropenia 0.7 2.1
General disorders and administration site conditions 6.6 8
  Fatigue 2.8 2.1
  Pain 1 2.8
Respiratory/thoracic 5.2 7.7
  Cough 2.8 1.7
  Pharyngeal pain 0.7 2.4
Investigations 5.5 6.3
  Increased GGT 1.0 2.8

Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and alteredtaste, were reported by 35 (12.1%) patients who received miconazole buccal tablet compared to 27 (9.4%) patients who received clotrimazole troches.

Head and Neck Cancer Patients

In the randomized, open-label comparative trial of oropharyngeal candidiasis in patients with head and neck cancer who had received radiation therapy (Study 2), 147 patients used ORAVIG once daily for 14 days and 147 patients used 125 mg of miconazole oral gel four times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either arm are listed in Table 2.

Table 2: Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of Patients with Head and Neck Cancer who had Received Radiation Therapy (Controlled Clinical Trial)

Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG
N = 147 (%)
Miconazole gel
N = 147 (%)
Patients with at least one adverse reaction 30 (20.4) 32 (21.8)
Gastrointestinal disorders 8.8 13.6
  Abdominal pain, upper 2.7 2
  Oral discomfort 1.4 2.7
  Nausea 0.7 2.7
  Vomiting 0.7 2
  Glossodynia 0 2
Nervous system disorders 5.4 1.4
  Dysgeusia 4.1 0
Skin and subcutaneous 3.4 0.7
  Pruritus 2 0.7

Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, andapplication site discomfort or pain, were experienced by 14 (9.5%) patients who used ORAVIG compared to 16 (10.9%) patients who used miconazole gel.

Overall ORAVIG Safety Experience In Patients and Healthy Subjects

Adverse reactions reported in the overall safety database of 480 subjects who receivedmiconazole buccal tablet is listed in Table 3.

Table 3 : Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received ORAVIG in Clinical Trials

Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG
N = 480 (%)
Patients with at least one AE 209 (43.5)
Gastrointestinal disorders 20.6
  Diarrhea 6
  Nausea 4.6
  Abdominal pain upper 2.5
  Vomiting 2.5
Infections and infestations 11.9
Nervous system disorders 10.6
  Headache 5
  Dysgeusia 2.9

Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.

Read the entire FDA prescribing information for Oravig (Miconazole Buccal Tablets)

Related Resources for Oravig

Related Health

Read the Oravig User Reviews »

© Oravig Patient Information is supplied by Cerner Multum, Inc. and Oravig Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors