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Fluconazole (Fluconazole) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Fluconazole is generally well tolerated.

In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.

In Patients Receiving a Single Dose for Vaginal Candidiasis

During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with fluconazole, 150 mg single dose. The overall incidence of side effects possibly related to fluconazole was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience.

In Patients Receiving Multiple Doses for Other Infections

Sixteen percent of over 4000 patients treated with fluconazole in clinical trials of 7 days or more experienced adverse events. Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% of patients due to laboratory test abnormalities.

Clinical adverse events were reported more frequently in HIV infected patients (21%) than in non-HIV infected patients (13%); however, the patterns in HIV infected and non-HIV infected patients were similar. The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%).

The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4048 patients receiving fluconazole for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%.

Hepatobiliary

In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with fluconazole (see WARNINGS). The spectrum of these hepatic reactions has ranged from mild transient elevations in transaminases to clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities. Instances of fatal hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly AIDS or malignancy) and often while taking multiple concomitant medications. Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. In each of these cases, liver function returned to baseline on discontinuation of fluconazole.

In two comparative trials evaluating the efficacy of fluconazole for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in fluconazole-treated patients in clinical trials. These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic. The incidence of abnormally elevated serum transaminases was greater in patients taking fluconazole concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.

Postmarketing Experience

In addition, the following adverse events have occurred during postmarketing experience.

Immunologic

In rare cases, anaphylaxis (including angioedema, face edema and pruritus) has been reported.

Body as a Whole

Asthenia, fatigue, fever, malaise.

Cardiovascular

QT prolongation, torsade de pointes (see PRECAUTIONS).

Central Nervous System

Seizures, dizziness.

Hematopoietic and Lymphatic

Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.

Metabolic

Hypercholesterolemia, hypertriglyceridemia, hypokalemia.

Gastrointestinal

Cholestasis, dry mouth, hepatocellular damage, dyspepsia, vomiting.

Other Senses

Taste perversion.

Musculoskeletal System

Myalgia

Nervous System

Insomnia, paresthesia, somnolence, tremor, vertigo.

Skin and Appendages

Acute generalized exanthematous-pustulosis, drug eruption, increased sweating, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis (see WARNINGS), alopecia.

Adverse Reactions in Children

The pattern and incidence of adverse events and laboratory abnormalities recorded during pediatric clinical trials are comparable to those seen in adults.

In Phase II/III clinical trials conducted in the United States and in Europe, 577 pediatric patients, ages 1 day to 17 years were treated with fluconazole at doses up to 15 mg/kg/day for up to 1,616 days. Thirteen percent of children experienced treatment-related adverse events. The most commonly reported events were vomiting (5%), abdominal pain (3%), nausea (2%), and diarrhea (2%). Treatment was discontinued in 2.3% of patients due to adverse clinical events and in 1.4% of patients due to laboratory test abnormalities. The majority of treatment-related laboratory abnormalities were elevations of transaminases or alkaline phosphatase.

Percentage of Patients With Treatment-Related Side Effects
Fluconazole (n = 577) Comparative Agents (n = 451)
With any side effect 13.0 9.3
Vomiting 5.4 5.1
Abdominal pain 2.8 1.6
Nausea 2.3 1.6
Diarrhea 2.1 2.2



REPORTS OF SUSPECTED FLUCONAZOLE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Fluconazole. The information is not vetted and should not be considered as verified clinical evidence.

Possible Fluconazole side effects / adverse reactions in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-09-09

Patient: 61 year old female weighing 66.0 kg (145.2 pounds)

Reactions: Neuroleptic Malignant Syndrome

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Quetiapine Fumarate
    Dosage: 400 mg/day, at bedtime

Haloperidol
    Dosage: 20 mg, at bedtime

Furosemide
    Dosage: 40 mg, daily

Sumatriptan Succinate
    Dosage: 50 mg, as needed

Alendronate Sodium
    Dosage: 70 mg, weekly

Omeprazole
    Dosage: 20 mg, 2x/day

Cyclobenzaprine HCL
    Dosage: 10 mg, as needed

Trimethoprim + Sulfamethoxazole
    Dosage: 160/800 ug daily for the past 3 months

Hydroxyzine HCL
    Dosage: 25 mg, 2x/day

Fluconazole
    Dosage: 150 mg x 1 (5-6 times in past 6 months)

Budesonide
    Dosage: 200 ug, 2 inhalations daily

Estrogens Conjugated
    Dosage: 1.3 mg, daily

Loperamide
    Dosage: 2 mg, (100 tablets/month) as needed

Albuterol
    Dosage: 100 ug, as needed

Risperidone
    Dosage: 2 mg in the morning, 3 mg at bedtime

Mometasone Furoate
    Dosage: 0.05 %, 2 sprays twice daily

Trazodone HCL
    Dosage: 200 mg, at bedtime

Venlafaxine HCL
    Dosage: 75 mg, 2x/day

Levothyroxine Sodium
    Dosage: 50 ug, daily

Celecoxib
    Dosage: 200 mg, 2x/day

Desipramine HCL
    Dosage: 25 mg, 2x/day

Prednisone TAB
    Dosage: 7.5 mg, 1x/day

Hydroxychloroquine Sulfate
    Dosage: 200 mg, 2x/day

Trimethoprim + Sulfamethoxazole
    Dosage: 160/800 ug daily for the past 3 months

Other drugs received by patient: Atorvastatin Calcium; Lorazepam



Possible Fluconazole side effects / adverse reactions in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03

Patient: 44 year old female

Reactions: Mouth Ulceration, Oedema Mouth

Suspect drug(s):
Fluconazole

Other drugs received by patient: Prednisolone; Nystatin; Clotrimazole



Possible Fluconazole side effects / adverse reactions in 58 year old female

Reported by a physician from France on 2011-10-03

Patient: 58 year old female weighing 60.0 kg (132.0 pounds)

Reactions: Skin Exfoliation

Adverse event resulted in: hospitalization

Suspect drug(s):
Fluconazole
    Dosage: 50 mg, bid
    Administration route: Oral
    Start date: 2001-10-12

Debridat
    Dosage: 600 mg, 1x/day
    Administration route: Oral
    Start date: 2001-10-12

Paclitaxel
    Dosage: 140 mg, qd
    Start date: 2001-10-31
    End date: 2001-10-31

Furosemide
    Dosage: 20 mg, qd
    Administration route: Oral
    Start date: 2001-10-12

Omeprazole
    Dosage: 20 mg, qd
    Administration route: Oral
    Start date: 2001-10-12

Medrol
    Dosage: 16 mg, tid
    Administration route: Oral
    Start date: 2001-10-12

Other drugs received by patient: Motilium-M; Cernevit-12; Ferrous Gluconate



See index of all Fluconazole side effect reports >>

Drug label data at the top of this Page last updated: 2012-09-05

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