Funtas Side effects

• Side effects of Funtas in details
• Funtas contraindications
• Funtas reviews

What are the possible side effects of Funtas?

Get emergency medical help if you have any of these signs of an allergic reaction to Funtas: 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 Funtas 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 Funtas in details

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 Funtas 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 Funtas, 287 control) and one non-comparative trial (N = 25).

In the randomized, double blind trial (Study 1), 290 HIV infected subjects used Funtas 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)	Funtas 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 Funtas 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 Funtas once daily for 14 days and 147 patients used 125 mg of Funtas 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)	Funtas N = 147 (%)	Funtas 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 Funtas compared to 16 (10.9%) patients who used Funtas gel.

Overall Funtas Safety Experience In Patients and Healthy Subjects

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

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

Adverse reaction (MedDRA v 9.1 System Organ Class and Preferred Term)	Funtas 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 Funtas due to adverse drug reactions occurred in 0.6% overall.

What is the most important information I should know about Funtas?

• Funtas cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Funtas cream in your eyes, flush with a generous amount of cool water.
• It is important to use Funtas cream for the full course of treatment. Failure to do so may decrease the effectiveness of Funtas cream and increase the risk that the fungus will no longer be sensitive to Funtas 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 Funtas cream and contact your health care provider at once. You may have a more serious illness.
• Do not use Funtas 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 Funtas cream. Change out of wet bathing suits or damp workout clothes as soon as possible.
• Continue using Funtas cream even during your menstrual period. Do not use tampons while you are using Funtas cream or until all of your symptoms go away. Use unscented pads or pantiliners.
• Do not have vaginal sexual intercourse while you are using Funtas cream.
• Funtas 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 Funtas cream.
• Do not use tampons, douches, spermicides, or other vaginal products while using Funtas cream.
• Overuse of topical products may worsen your condition.
• Do not use Funtas 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 Funtas cream, discuss with your doctor the benefits and risks of using Funtas cream during pregnancy. It is unknown if Funtas cream is excreted in breast milk. If you are or will be breast-feeding while you are using Funtas cream, check with your doctor or pharmacist.

Funtas contraindications

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 Funtas 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 Funtas. 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

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Information checked by Dr. Sachin Kumar, MD Pharmacology