Oravig
- Generic Name: miconazole buccal tablets
- Brand Name: Oravig
Oravig (Miconazole Buccal Tablets) side effects drug center
Oravig Side Effects Center
What Is Oravig?
Oravig (miconazole) Buccal Tablets is an antifungal medication used to treat candida (yeast) infections inside the mouth.
What Are Side Effects of Oravig?
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.
Dosage for Oravig
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.
What Drugs, Substances, or Supplements Interact with Oravig?
Oravig may interact with other drugs. Tell your doctor or dentist all medications and supplements you use.
Oravig During Pregnancy and Breastfeeding
During pregnancy, Oravig should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
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Our Oravig (miconazole) 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.
Oravig Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; trouble swallowing or breathing; swelling of your face, lips, tongue, or throat.
Common side effects may include:
- nausea, vomiting, stomach pain;
- diarrhea;
- headache; or
- changes in your sense of taste.
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 of labeling:
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trial 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 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 ≥ 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 during the study | 158 (54.5) | 146 (50.9) |
| Gastrointestinal disorders | 25.9 | 23.7 |
| Diarrhea | 9.0 | 8.0 |
| 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 | 8.0 |
| Fatigue | 2.8 | 2.1 |
| Pain | 1.0 | 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 altered taste, 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 | 1.4 | 2.0 |
| Oral discomfort | 2.7 | 2.7 |
| Nausea | 0.7 | 2.7 |
| Vomiting | 0.7 | 2.0 |
| Glossodynia | 0 | 2.0 |
| Nervous system disorders | 5.4 | 1.4 |
| Dysgeusia | 4.1 | 0 |
| Skin and subcutaneous | 3.4 | 0.7 |
| Pruritus | 2.0 | 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, and application 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 received miconazole 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 | 6.0 |
| Nausea | 4.6 |
| Abdominal pain upper | 2.5 |
| Vomiting | 2.5 |
| Infections and infestations | 11.9 |
| Nervous system disorders | 10.6 |
| Headache | 5.0 |
| 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)
&Copy; 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.