Miconazole Side effects

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What are the possible side effects of Miconazole?

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:

Less serious Miconazole side effects may include:

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:

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 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

  1. 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).
  2. 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).
  3. 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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Information checked by Dr. Sachin Kumar, MD Pharmacology

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