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Diflucan (Fluconazole) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

DIFLUCAN 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 DIFLUCAN, 150 mg single dose. The overall incidence of side effects possibly related to DIFLUCAN 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 DIFLUCAN (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 DIFLUCAN 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 DIFLUCAN. (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 DIFLUCAN.

In two comparative trials evaluating the efficacy of DIFLUCAN 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 DIFLUCAN concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.

Post-Marketing Experience

In addition, the following adverse events have occurred during post-marketing 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 DIFLUCAN 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 DIFLUCAN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Diflucan side effects / adverse reactions in 66 year old male

Reported by a physician from Japan on 2011-10-24

Patient: 66 year old male

Reactions: Pneumonia, Interstitial Lung Disease

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Cytarabine
    Dosage: 40 mg, daily
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Sulfamethoxazole
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Start date: 2011-07-15

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2011-07-12
    End date: 2011-07-19

Meropenem
    Dosage: 1 g, 3x/day
    Start date: 2011-07-04
    End date: 2011-07-15

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-11-24
    End date: 2010-11-24

Sulfamethoxazole
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-28

Allopurinol
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2011-07-05
    End date: 2011-07-19

Fentanyl
    Dosage: unk
    Indication: Stomatitis
    Start date: 2011-01-02
    End date: 2011-01-19

Magmitt
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Prednisolone
    Dosage: 10 mg, daily
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    End date: 2011-02-17

Cefazolin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Proctitis
    Start date: 2010-10-22
    End date: 2011-02-17

Baraclude
    Dosage: 0.5 mg, 1/2day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2010-06-29
    End date: 2011-07-19

Oncovin
    Dosage: 1 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Cymerin
    Dosage: 60 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-14
    End date: 2010-12-29

Etoposide
    Dosage: 100 mg/m2, 3x/day
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Allopurinol
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Hyperuricaemia
    End date: 2011-01-20

Pantosin
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-12-29
    End date: 2010-12-29

Prednisolone
    Dosage: 40 mg/m2, unk
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-29

Fildesin
    Dosage: 2.4 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-10-14
    End date: 2010-10-14

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Start date: 2010-12-22
    End date: 2010-12-22

Methotrexate Sodium
    Dosage: 15 mg, daily
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Amlodipine
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-10-08
    End date: 2011-02-17

Diflucan
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-11

KW-0761
    Dosage: 1 mg/kg, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-08
    End date: 2010-12-21

Cyclophosphamide
    Dosage: 350 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Start date: 2011-05-26
    End date: 2011-07-19

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Start date: 2010-11-16
    End date: 2010-11-16

Diflucan
    Dosage: unk
    Start date: 2011-01-19
    End date: 2011-01-28

Vancomycin
    Dosage: 0.5 g, 2x/day
    Start date: 2011-01-07
    End date: 2011-01-17

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-29
    End date: 2011-07-19

Carboplatin
    Dosage: 250 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Zovirax
    Dosage: unk
    Start date: 2011-06-30
    End date: 2011-07-08

Lipidil
    Dosage: 100 df, 1x/day
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-01-26

Meropenem
    Dosage: 0.5 g, 2x/day
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-24

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-10-07

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-28

Other drugs received by patient: Ciprofloxacin HCL; Vfend; Slow-K; Targocid



Possible Diflucan side effects / adverse reactions in 75 year old female

Reported by a pharmacist from Japan on 2011-10-28

Patient: 75 year old female

Reactions: Disturbance in Attention

Suspect drug(s):
Diflucan

Other drugs received by patient: Fluconazole; Ancotil; Ancotil; Fungizone; Fungizone



Possible Diflucan side effects / adverse reactions in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-01

Patient: male

Reactions: Pneumonia, Renal Disorder, Interstitial Lung Disease, Platelet Count Decreased, Herpes Zoster

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Diflucan
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-11

Prednisolone
    Dosage: 10 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Zovirax
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-28

Oncovin
    Dosage: 1 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Cyclophosphamide
    Dosage: 350 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Cymerin
    Dosage: 60 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-14
    End date: 2010-12-29

Doxorubicin Hydrochloride
    Dosage: 30 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-12-29
    End date: 2010-12-29

Doxorubicin Hydrochloride
    Dosage: 40 milligram/sq.meter
    Start date: 2010-11-16
    End date: 2010-11-16

Zovirax
    Administration route: Oral
    Start date: 2011-07-12
    End date: 2011-07-19

Lyrica
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-29
    End date: 2011-07-19

Doxorubicin Hydrochloride
    Dosage: 30 milligram/sq.meter
    Start date: 2010-10-14
    End date: 2010-10-14

Doxorubicin Hydrochloride
    Dosage: 30 milligram/sq.meter
    Start date: 2010-11-24
    End date: 2010-11-24

Allopurinol
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-20

Other Antitumor Agents
    Dosage: 1 milligram/kilogram
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-08
    End date: 2010-12-21

Cefazolin Sodium
    Indication: Proctitis
    Start date: 2010-10-22
    End date: 2011-02-17

Fildesin
    Dosage: 2.4 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Etoposide
    Dosage: 100 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Doxorubicin Hydrochloride
    Dosage: 40 milligram/sq.meter
    Start date: 2010-12-22
    End date: 2010-12-22

Doxorubicin Hydrochloride
    Dosage: 40 milligram/sq.meter
    Start date: 2010-10-07
    End date: 2010-10-07

Meropenem
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-24

Meropenem
    Start date: 2011-07-04
    End date: 2011-07-15

Vancomycin Hychloride
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-17

Allopurinol
    Administration route: Oral
    Start date: 2011-07-05
    End date: 2011-07-19

Carboplatin
    Dosage: 250 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Methotrexate
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Cytarabine
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Pantosin
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Fentanyl Citrate
    Indication: Stomatitis
    Start date: 2011-01-02
    End date: 2011-01-19

Lansoprazole
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    End date: 2011-02-17

Lipidil
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-01-26

Prednisolone
    Dosage: 40 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2010-10-07
    End date: 2010-12-29

Magmitt
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Baraclude
    Indication: Hepatitis B
    Start date: 2011-06-29
    End date: 2011-07-19

Amlodipine
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-10-08
    End date: 2011-02-17

Lansoprazole
    Administration route: Oral
    Start date: 2011-05-26
    End date: 2011-07-19

Sulfamethoxazole
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-28

Sulfamethoxazole
    Administration route: Oral
    Start date: 2011-07-15

Other drugs received by patient: Targocid; Vfend; Slow-K; Ciprofloxacin HCL



See index of all Diflucan side effect reports >>

Drug label data at the top of this Page last updated: 2012-05-22

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