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Fluconazole (Fluconazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fluconazole and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (649)
Death (101)
Life Threatening Events (65)
Disability (18)

Reports by Reaction Type

Drug Interaction (79)Pyrexia (53)Septic Shock (37)Neutropenia (36)Hepatotoxicity (34)Drug Rash With Eosinophilia and Systemic Symptoms (34)Blood Bilirubin Increased (28)Drug Ineffective (28)Renal Failure Acute (28)Thrombocytopenia (27)Toxicity To Various Agents (26)Renal Failure (25)

Below are a few examples of reports where side effects / adverse reactions may be related to Fluconazole. For a complete list or a specific selection of reports, please use the links above.

Possible Fluconazole side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: male

Reactions: Haemoglobin Decreased, Drug Rash With Eosinophilia and Systemic Symptoms, Blood Sodium Decreased, Myocarditis, Blood Creatinine Increased, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 2 tablets at 400 mg a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09



Possible Fluconazole side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Eyelid Oedema, Lymphadenopathy, Skin Exfoliation, Conjunctivitis, Tachycardia, Scab, Pyrexia, Cheilitis, Penile Ulceration, Face Oedema, Scrotal Oedema, Optic Disc Haemorrhage, Myocarditis, Stevens-Johnson Syndrome, Dysphagia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Troponin Increased, LIP Haemorrhage, Drug Rash With Eosinophilia and Systemic Symptoms, Anal Erosion, Mucosal Erosion, Cardiac Failure, Cytomegalovirus Chorioretinitis, Epidermal Necrosis, Electrocardiogram Abnormal, Oedema Genital, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 1unit per day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 1tab twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 6g per day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Other drugs received by patient: Malocide; Folinate



Possible Fluconazole side effects in 76 year old female

Reported by a consumer/non-health professional from Sweden on 2012-08-27

Patient: 76 year old female

Reactions: Angioedema, Fungal Infection

Drug(s) suspected as cause:
Amoxicillin

Fluconazole

Mycostatin



Possible Fluconazole side effects in male

Reported by a physician from France on 2012-08-24

Patient: male

Reactions: Dysphagia, Cytomegalovirus Chorioretinitis, Drug Hypersensitivity, Conjunctivitis, Drug Rash With Eosinophilia and Systemic Symptoms, Myocarditis, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Administration route: Oral
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2012-06-12
    End date: 2012-07-05

Bactrim
    Indication: Prophylaxis

Combivir
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: LIP DRY, Chapped Lips, LIP Haemorrhage, LIP Exfoliation

Drug(s) suspected as cause:
Fluconazole
    Dosage: 50 mg, once a day
    Indication: Postoperative Care

Fluconazole
    Dosage: 200 mg, once a day



Possible Fluconazole side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 58 year old male

Reactions: Tachycardia, Transferrin Decreased, Cerebral Toxoplasmosis, Transferrin Saturation Decreased, Eye Haemorrhage, Gamma-Glutamyltransferase Increased, Blood Sodium Decreased, Myocarditis, Electrocardiogram Repolarisation Abnormality, Stevens-Johnson Syndrome, Blood Iron Decreased, Blood Lactate Dehydrogenase Increased, Renal Cyst, Drug Rash With Eosinophilia and Systemic Symptoms, Nephrotic Syndrome, Renal Failure, Cytomegalovirus Chorioretinitis, Electrocardiogram ST Segment Elevation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 1 tablet, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Combivir
    Dosage: 1 df, 2x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Norvir
    Dosage: 100 mg, 1x/day (1 df)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Dosage: 400 mg, 1x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 6 g, 1x/day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Other drugs received by patient: Malocide; Malocide; Calcium Folinate; Malocide



Possible Fluconazole side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 60 year old male

Reactions: Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betadine
    Dosage: 2 l, 1x/day
    Start date: 2012-07-21
    End date: 2012-07-26

Betadine
    Dosage: 1 l, 1x/day
    Administration route: Topical
    Indication: Wound Treatment
    Start date: 2012-07-20
    End date: 2012-07-20

Fluconazole
    Dosage: 400 mg, 1x/day
    Start date: 2012-07-20
    End date: 2012-07-25

Imovane
    Dosage: 7.5 mg, 1x/day - 1df daily
    Administration route: Oral
    Start date: 2012-07-22
    End date: 2012-07-25



Possible Fluconazole side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Confusional State, Agitation, Hypokinesia, Insomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ditropan
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Urinary Incontinence
    Start date: 2012-06-02
    End date: 2012-06-08

Fluconazole
    Dosage: 100 mg, bid
    Administration route: Oral
    Indication: Fungal Infection
    Start date: 2012-06-04
    End date: 2012-06-10

Invanz
    Dosage: 1 g, bid
    Indication: Osteitis
    Start date: 2012-06-01
    End date: 2012-06-10

Tramadol HCL
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Pain in Extremity
    Start date: 2012-05-30
    End date: 2012-06-08

Zolpidem Tartrate
    Dosage: 10 mg, qd
    Administration route: Oral
    Indication: Insomnia
    Start date: 2012-05-21
    End date: 2012-06-10

Other drugs received by patient: Bactrim



Possible Fluconazole side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 65 year old male

Reactions: Multi-Organ Failure, Metabolic Acidosis, Rash, Rash Morbilliform, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Rash Pruritic

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fluconazole
    Indication: Evidence Based Treatment

Levofloxacin
    Indication: Evidence Based Treatment

Metronidazole
    Indication: Evidence Based Treatment

Vancomycin
    Indication: Evidence Based Treatment



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Fungal Infection, Drug Ineffective

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-22

Patient:

Reactions: Adverse Drug Reaction, Liver Disorder

Drug(s) suspected as cause:
Allopurinol
    Indication: Product Used FOR Unknown Indication

Aminoglycoside Antibacterials
    Indication: Product Used FOR Unknown Indication

Amoxicillin and Clavulanate Potassium
    Indication: Product Used FOR Unknown Indication

AN Unknown Medication
    Indication: Product Used FOR Unknown Indication

Anti-Psychotics
    Indication: Product Used FOR Unknown Indication

Atazanavir
    Indication: Product Used FOR Unknown Indication

Cephalosporins
    Indication: Product Used FOR Unknown Indication

Clindamycin
    Indication: Product Used FOR Unknown Indication

Fluconazole
    Indication: Product Used FOR Unknown Indication

Herbal Medicines
    Indication: Product Used FOR Unknown Indication

Itraconazole
    Indication: Product Used FOR Unknown Indication

Nucleoside Reverse Transcriptase Inhibitors
    Indication: Product Used FOR Unknown Indication

Piperacillin and Tazobactam
    Indication: Product Used FOR Unknown Indication

Propyl-Thiouracil
    Indication: Product Used FOR Unknown Indication

Protease Inhibitors
    Indication: Product Used FOR Unknown Indication

Topiramate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Tramadol Hydrochloride and Acetaminophen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Fluconazole side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Adverse Event, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome

Drug(s) suspected as cause:
Bisacodyl
    Indication: Product Used FOR Unknown Indication

Darunavir Ethanolate
    Indication: Product Used FOR Unknown Indication

Erythromycin
    Indication: Product Used FOR Unknown Indication

Famotidine
    Indication: Product Used FOR Unknown Indication

Fluconazole
    Indication: Product Used FOR Unknown Indication

Griseofulvin
    Indication: Product Used FOR Unknown Indication

Indomethacin
    Indication: Product Used FOR Unknown Indication

Ketoprofen
    Indication: Product Used FOR Unknown Indication

Levofloxacin
    Indication: Product Used FOR Unknown Indication

Naproxen
    Indication: Product Used FOR Unknown Indication

Ofloxacin
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Indication: Product Used FOR Unknown Indication



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Dyspnoea, Headache

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Pruritus, Swelling, Rash Erythematous, Erythema, Blister, Wound Secretion

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Regurgitation, Vomiting, Retching, Dyspepsia, Respiratory Tract Irritation, Cough

Drug(s) suspected as cause:
Fluconazole
    Indication: Infection

Fluconazole



Possible Fluconazole side effects in

Reported by a pharmacist from United States on 2012-08-21

Patient:

Reactions: Alopecia

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Pharyngeal Oedema, Diarrhoea, Pain, Rash

Drug(s) suspected as cause:
Fluconazole

Other drugs received by patient: Azithromycin



Possible Fluconazole side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Abdominal Discomfort, Diarrhoea, Rash, Abdominal Pain Upper

Drug(s) suspected as cause:
Fluconazole

Other drugs received by patient: Procaterol HCL; Cyclobenzaprine



Possible Fluconazole side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient:

Reactions: Skin Lesion

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Burning Sensation, Sputum Discoloured

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a pharmacist from United States on 2012-08-21

Patient: female

Reactions: Vulvovaginal Mycotic Infection, International Normalised Ratio Increased

Drug(s) suspected as cause:
Fluconazole
    Dosage: 150mg 2 day1, 1 day 2 po
    Administration route: Oral
    Indication: Vulvovaginal Mycotic Infection
    Start date: 2012-08-01
    End date: 2012-08-02

Warfarin 5MG Unknown
    Dosage: 5mg once daily po
    Administration route: Oral
    Indication: Deep Vein Thrombosis
    Start date: 2012-08-01
    End date: 2012-08-02

Other drugs received by patient: Digestive Enzymes; Iron, B-Complex; Multi-Vitamin



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Fungal Infection

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Psychomotor Hyperactivity, Insomnia, Disturbance in Attention, Mood Swings, Aggression

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Pruritus, Swelling, Rash Erythematous, Erythema, Blister, Wound Secretion

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Drug Ineffective, Sinus Headache, Headache

Drug(s) suspected as cause:
Fluconazole



Possible Fluconazole side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Fluconazole

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