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 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 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 2012-08-24
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 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 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 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 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 2012-08-21
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
Possible Fluconazole side effects in
Reported by a pharmacist from United States on 2012-08-21
Patient:
Reactions: Gastric Disorder
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: Hypersensitivity, Skin Reaction
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: Back Pain, Migraine, Pain in Extremity, Hypoaesthesia, Paraesthesia, Insomnia, Chest Pain, Dizziness, Heart Rate Irregular, Feeling Abnormal, Muscle Spasms
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: Decreased Appetite
Drug(s) suspected as cause:
Fluconazole
Other drugs received by patient: Nitrofurantoin; Thyroid Medication (Nos)
Possible Fluconazole side effects in 39 year old male
Reported by a health professional (non-physician/pharmacist) from Bulgaria on 2012-08-21
Patient: 39 year old male
Reactions: Arterial Thrombosis, Cardiac Valve Vegetation, Pathogen Resistance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fluconazole
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