Get emergency medical help if you have any of these signs of an allergic reaction to Miconazole: 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 Miconazole 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.
Side effects of Miconazole in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following serious adverse drug reactions are discussed in detail in other sections of labeling:
Hypersensitivity reactions
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 Miconazole 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 Miconazole, 287 control) and one non-comparative trial (N = 25).
In the randomized, double blind trial (Study 1), 290 HIV infected subjects used Miconazole 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)
Miconazole
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 Miconazole 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)
Miconazole
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
2.0
Oral discomfort
1.4
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 Miconazole compared to 16 (10.9%) patients who used Miconazole gel.
Overall Miconazole 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 Miconazole in Clinical Trials
Adverse reaction
(MedDRA v 9.1 System Organ Class and Preferred Term)
Miconazole
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 Miconazole due to adverse drug reactions occurred in 0.6% overall.
What is the most important information I should know about Miconazole?
Miconazole cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Miconazole cream in your eyes, flush with a generous amount of cool water.
It is important to use Miconazole cream for the full course of treatment. Failure to do so may decrease the effectiveness of Miconazole cream and increase the risk that the fungus will no longer be sensitive to Miconazole cream and will not be able to be treated by this or certain other antibiotics in the future.
If your symptoms do not improve within 3 days, if they last more than 7 days, or if they become worse, stop using Miconazole cream and contact your health care provider at once. You may have a more serious illness.
Do not use Miconazole cream for itching caused by other conditions.
Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Miconazole cream. Change out of wet bathing suits or damp workout clothes as soon as possible.
Continue using Miconazole cream even during your menstrual period. Do not use tampons while you are using Miconazole cream or until all of your symptoms go away. Use unscented pads or pantiliners.
Do not have vaginal sexual intercourse while you are using Miconazole cream.
Miconazole cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use these products for at least 1 day after treatment with Miconazole cream.
Do not use tampons, douches, spermicides, or other vaginal products while using Miconazole cream.
Overuse of topical products may worsen your condition.
Do not use Miconazole cream in CHILDREN younger than 12 years of age unless advised to do so by your health care provider.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Miconazole cream, discuss with your doctor the benefits and risks of using Miconazole cream during pregnancy. It is unknown if Miconazole cream is excreted in breast milk. If you are or will be breast-feeding while you are using Miconazole cream, check with your doctor or pharmacist.
Miconazole contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Patients with any kind of liver disease; hypersensitivity to any of the ingredients of Daktarin
Oral Gel.
The effects and/or side effects of many prescription medications, when taken with Daktarin
Oral Gel, can be increased. Hence, patients taking or about to take any other medications, must consult the doctor or pharmacist before starting Daktarin
Oral Gel therapy.
Use in infants: Daktarin
Oral Gel is contraindicated in infants <6 months because of the risk of choking.
References
DailyMed. "MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DTP/NCI. "miconazole: 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. "Miconazole: 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).
Reviews
The results of a survey conducted on ndrugs.com for Miconazole 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 Miconazole. 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.
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