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Doxil (Doxorubicin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Doxil (Doxorubicin) 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 (115)
Death (54)
Life Threatening Events (15)
Disability (4)

Reports by Reaction Type

Death (19)Asthenia (14)Nausea (12)Failure To Thrive (10)Interstitial Lung Disease (10)Dyspnoea (10)Sepsis (10)Ovarian Cancer Recurrent (9)Off Label Use (9)Pancytopenia (9)Multiple Myeloma (8)Vomiting (8)

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

Possible Doxil side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Carbohydrate Antigen 125 Increased

Drug(s) suspected as cause:
Doxil



Possible Doxil side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female, weighing 70.8 kg (155.8 pounds)

Reactions: Abdominal Pain, Hyperpyrexia, Anaphylactic Reaction, Chills, Pain, Hepatic Failure, Transaminases Increased, Splenic Infarction, Loss of Consciousness, Aortic Thrombosis, Off Label Use, Malaise, C-Reactive Protein Increased, Myositis, Dyspnoea, Hypotension, Arrhythmia, Lung Consolidation, Hypophosphataemia, Zygomycosis, Bacteraemia, Ventricular Tachycardia, Hyperammonaemia, Neutropenia, Hepatic Infarction, Shock, Infusion Related Reaction

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Vincristine
    Dosage: day 1,8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Decadron Phosphate
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23

Velcade
    Dosage: day 1, 4, 8 and 11
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Cytarabine
    Dosage: day 1,8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23

Methotrexate
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2005-01-01
    End date: 2007-01-01

PEG-Asparaginase
    Dosage: day 2, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-25
    End date: 2007-10-25

Doxil
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23



Possible Doxil side effects in

Reported by a physician from Korea, Republic of on 2012-07-30

Patient:

Reactions: Blood Bilirubin Increased, Hepatic Function Abnormal, Transaminases Increased, Disease Progression

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Doxil
    Dosage: 50 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22

Velcade
    Dosage: 1.60 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22

Prednisone
    Dosage: 100 mg, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-26

Vincristine
    Dosage: 1.4 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22

Cyclophosphamide
    Dosage: 750 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22



Possible Doxil side effects in

Reported by a physician from Korea, Republic of on 2012-07-24

Patient:

Reactions: Blood Bilirubin Increased, Hepatic Function Abnormal, Transaminases Increased, Disease Progression

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 750 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22

Velcade
    Dosage: 1.60 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22

Vincristine
    Dosage: 1.4 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22

Doxil
    Dosage: 50 mg/m2, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-22

Prednisone
    Dosage: 100 mg, unk
    Indication: T-Cell Lymphoma
    Start date: 2008-01-24
    End date: 2008-02-26



Possible Doxil side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Off Label Use, Uterine Cancer, Nausea, Intestinal Obstruction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil



Possible Doxil side effects in

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient:

Reactions: Pancreatitis Acute, Abdominal Pain, Drug Interaction, Death, Abdominal Distension, Thrombocytopenia, Cardiac Failure Congestive, Stomatitis, Nausea, Palmar-Plantar Erythrodysaesthesia Syndrome, Odynophagia, Breast Cancer Metastatic, Osteonecrosis, Pancreatitis, Neutropenia, Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxil

Other drugs received by patient possibly interacting with the suspect drug:
Bevacizumab
    Indication: Breast Cancer Metastatic

Carboplatin
    Indication: Breast Cancer Metastatic

Other drugs received by patient: Unknown Medication



Possible Doxil side effects in female

Reported by a physician from United States on 2012-07-18

Patient: female

Reactions: Hypersensitivity, Immunology Test Abnormal

Drug(s) suspected as cause:
Doxil
    Dosage: over 1 hour, every 4 weeks
    Indication: Neoplasm Malignant

Placebo
    Dosage: the first morning before the pld infusion and twice daily thereafter
    Administration route: Oral
    Indication: Prophylaxis



Possible Doxil side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Neuropathy Peripheral, Sensation of Heaviness

Drug(s) suspected as cause:
Doxil



Possible Doxil side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-06

Patient: 49 year old female

Reactions: Neoplasm Malignant, Swelling, Pancytopenia, Rash, Neurological Symptom, Generalised Oedema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 1df=auc5 also auc4
    Indication: Peritoneal Carcinoma Metastatic

Cytarabine
    Indication: Peritoneal Carcinoma Metastatic

Methotrexate
    Indication: Peritoneal Carcinoma Metastatic

Mitomycin
    Dosage: inj
    Indication: Peritoneal Carcinoma Metastatic

Cyclophosphamide
    Dosage: cyclophosphamide hydrate day1 also 600mg/m2
    Indication: Peritoneal Carcinoma Metastatic

Prednisolone
    Indication: Peritoneal Carcinoma Metastatic

Doxil
    Indication: Peritoneal Carcinoma Metastatic

Irinotecan HCL
    Dosage: on day 1, 15
    Indication: Peritoneal Carcinoma Metastatic

Epirubicin Hydrochloride
    Dosage: day1
    Indication: Peritoneal Carcinoma Metastatic

Nedaplatin
    Dosage: also 60mg/m2,12mg/m2(days1-15),120mg/m2
    Indication: Peritoneal Carcinoma Metastatic

Paclitaxel
    Indication: Peritoneal Carcinoma Metastatic

Docetaxel
    Indication: Peritoneal Carcinoma Metastatic



Possible Doxil side effects in

Reported by a physician from United States on 2012-07-06

Patient:

Reactions: Stomatitis, Hepatic Failure, Palmar-Plantar Erythrodysaesthesia Syndrome, Febrile Neutropenia, Haematotoxicity, Cardiac Disorder, Neutropenia, Thrombocytopenia, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Diffuse Large B-Cell Lymphoma

Neulasta
    Dosage: on day 2 of a 14 day cycle
    Indication: Diffuse Large B-Cell Lymphoma

Prednisone TAB
    Dosage: day 1-5
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma

Vincristine
    Dosage: 2 mg max
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Dosage: on day 1
    Indication: Diffuse Large B-Cell Lymphoma

Doxil
    Dosage: cohort 1: 20 mg/m2 cohort ii: 25 mg/m2 cohort iii: 30 mg/m2
    Indication: Diffuse Large B-Cell Lymphoma



Possible Doxil side effects in

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxil



Possible Doxil side effects in female

Reported by a physician from Japan on 2012-07-02

Patient: female

Reactions: Nausea, Cystitis Haemorrhagic, Bone Marrow Failure

Drug(s) suspected as cause:
Ifosfamide
    Dosage: day 1 to 5, total 10 cycles
    Indication: Phyllodes Tumour

Doxil
    Dosage: doxorubicin hydrochloride was included after cycle 2 until cycle 5
    Indication: Phyllodes Tumour



Possible Doxil side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27

Patient:

Reactions: Hepatic Failure, Cardiac Disorder, Renal Failure Acute, Haematotoxicity

Adverse event resulted in: death

Drug(s) suspected as cause:
Vincristine
    Dosage: 2 mg max
    Indication: Diffuse Large B-Cell Lymphoma

Doxil
    Dosage: cohort 1: 20 mg/m2 cohort ii: 25 mg/m2 cohort iii: 30 mg/m2
    Indication: Diffuse Large B-Cell Lymphoma

Neulasta
    Dosage: on day 2 of a 14 day cycle
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Dosage: on day 1
    Indication: Diffuse Large B-Cell Lymphoma

Cyclophosphamide
    Indication: Diffuse Large B-Cell Lymphoma

Prednisone TAB
    Dosage: day 1-5
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma



Possible Doxil side effects in 49 year old female

Reported by a consumer/non-health professional from Japan on 2012-06-25

Patient: 49 year old female

Reactions: Neoplasm Malignant, Swelling, Pancytopenia, Rash, Neurological Symptom, Generalised Oedema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mitomycin
    Dosage: inj
    Indication: Peritoneal Carcinoma Metastatic

Nedaplatin
    Dosage: also 60mg/m2,12mg/m2(days1-15),120mg/m2
    Indication: Peritoneal Carcinoma Metastatic

Irinotecan HCL
    Dosage: on day 1, 15
    Indication: Peritoneal Carcinoma Metastatic

Cytarabine
    Indication: Peritoneal Carcinoma Metastatic

Doxil
    Indication: Peritoneal Carcinoma Metastatic

Epirubicin Hydrochloride
    Dosage: day1
    Indication: Peritoneal Carcinoma Metastatic

Docetaxel
    Indication: Peritoneal Carcinoma Metastatic

Methotrexate
    Indication: Peritoneal Carcinoma Metastatic

Prednisolone
    Indication: Peritoneal Carcinoma Metastatic

Carboplatin
    Dosage: 1df=auc5 also auc4
    Indication: Peritoneal Carcinoma Metastatic

Paclitaxel
    Indication: Peritoneal Carcinoma Metastatic

Cyclophosphamide
    Dosage: cyclophosphamide hydrate day1 also 600mg/m2
    Indication: Peritoneal Carcinoma Metastatic



Possible Doxil side effects in 65 year old female

Reported by a physician from United States on 2012-06-06

Patient: 65 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Off Label Use, Hospitalisation, Angiosarcoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil

Other drugs received by patient: Blood Thinners; Cardiac Medications



Possible Doxil side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: 59 year old female

Reactions: Drug Interaction, Pancreatitis

Drug(s) suspected as cause:
Doxil

Other drugs received by patient possibly interacting with the suspect drug:
Carboplatin
    Dosage: used for 1-4 months
    Indication: Breast Cancer

Bevacizumab
    Dosage: used for 1-6 months
    Indication: Breast Cancer



Possible Doxil side effects in 85 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: 85 year old male, weighing 82.1 kg (180.6 pounds)

Reactions: Diabetes Mellitus, Oral Candidiasis, Interstitial Lung Disease, Acute Respiratory Distress Syndrome, Blood Creatinine Increased, Blood Urea Increased, Vomiting, Blood Chloride Decreased, Aortic Calcification, Atrial Fibrillation, Pancytopenia, Hyponatraemia, Mitral Valve Calcification, Brain Natriuretic Peptide Increased, Pernicious Anaemia, Dehydration, Mitral Valve Incompetence, Hypothyroidism, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revlimid
    Dosage: 10 mg/daily/po
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-01-31
    End date: 2011-02-13

Decadron
    Dosage: 40 mg/wky/
    Indication: Multiple Myeloma
    Start date: 2011-01-31
    End date: 2011-02-10

Doxil
    Dosage: 8 mg
    Indication: Multiple Myeloma
    Start date: 2011-01-31
    End date: 2011-02-10

Velcade
    Dosage: 2 mg
    Indication: Multiple Myeloma
    Start date: 2011-01-31
    End date: 2011-02-13

Other drugs received by patient: Procrit; Aspirin; Neurontin; Zometa; Ciprofloxacin; Thioctic Acid; Synthroid; Dflucan; Calcium (Unspecified); Levoxyl; Acyclovir



Possible Doxil side effects in female

Reported by a physician from Japan on 2012-05-30

Patient: female

Reactions: Ovarian Cancer Recurrent, Pneumonia, Aspartate Aminotransferase Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil
    Dosage: cycle 2
    Indication: Ovarian Cancer Recurrent
    Start date: 2010-04-28
    End date: 2010-04-28

Doxil
    Dosage: cycle 1
    Start date: 2010-03-31
    End date: 2010-03-31

Doxil
    Dosage: cycle 3
    Start date: 2010-05-26
    End date: 2010-05-26

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

Doxil
    Dosage: cycle 4
    Start date: 2010-06-30
    End date: 2010-06-30

Doxil
    Dosage: cycle 5
    Start date: 2010-08-04
    End date: 2010-08-04

Other drugs received by patient: Loxoprofen Sodium; Clobetasol Propionate; Pursennid; Azunol; Zofran; Eurax; Mucosta; Loxoprofen Sodium; Cyanocobalamin; Oxatomide; Decadron; White Petrolatum; Hirudoid Cream; Granisetron; Premarin; Atarax; Myser; Lecicarbon; Decadron



Possible Doxil side effects in

Reported by a physician from United States on 2012-05-29

Patient:

Reactions: Anal Abscess

Drug(s) suspected as cause:
Avastin
    Indication: Ovarian Cancer

Doxil
    Indication: Ovarian Cancer



Possible Doxil side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-23

Patient: male

Reactions: Death, Gastrointestinal Haemorrhage

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 2.1 mg, unk
    Indication: Multiple Myeloma
    Start date: 2011-08-04
    End date: 2011-10-31

Doxil
    Dosage: 30 mg/m2, cyclic
    Indication: Multiple Myeloma
    Start date: 2011-08-08
    End date: 2011-10-14

Other drugs received by patient: Sorbitol 50pc INJ; Fentanyl-100; Pantoprazole; Epogen; Dexamethasone; Allopurinol; Docusate; Nephro-Vite / 02375601 /; Sevelamer



Possible Doxil side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: female

Reactions: Drug Dose Omission, Cholelithiasis, Death, Vomiting, Ovarian Cancer Recurrent, Nausea

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxil
    Indication: Ovarian Cancer
    Start date: 2011-01-01
    End date: 2011-01-01

Doxil
    Start date: 2011-01-01
    End date: 2011-01-01

Topotecan
    Indication: Ovarian Cancer
    Start date: 2011-01-01



Possible Doxil side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14

Patient: male

Reactions: Death

Adverse event resulted in: death

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

Carboplatin
    Indication: Product Used FOR Unknown Indication

Doxil
    Indication: Product Used FOR Unknown Indication



Possible Doxil side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10

Patient: male, weighing 64.9 kg (142.7 pounds)

Reactions: Hyperproteinaemia, Dysphagia, Sepsis, Aortic Aneurysm, Multiple Myeloma, Asthenia, Failure To Thrive, Cerebral Ischaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Bortezomib
    Indication: Multiple Myeloma
    Start date: 2010-07-01
    End date: 2010-08-04

Doxil
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Steroids NOS



Possible Doxil side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10

Patient: male, weighing 64.9 kg (142.7 pounds)

Reactions: Hyperproteinaemia, Sepsis, Aortic Aneurysm, Multiple Myeloma, Asthenia, Failure To Thrive, Cerebral Ischaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Multiple Myeloma
    Start date: 2010-07-01
    End date: 2010-08-04

Doxil
    Indication: Multiple Myeloma

Other drugs received by patient: Ambien; Zestril; Prilosec; Flomax; Apresoline; Zestril; Centrum Silver / 01292501 /; Miralax; Lortab; Cortef / 00028601 /; Ativan; Zofran; Norvasc; Flomax; Mucinex; Avodart; MS Contin; Lopurin



Possible Doxil side effects in male

Reported by a individual with unspecified qualification from United States on 2012-05-09

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Small Intestinal Obstruction, Abdominal Abscess, Diffuse Large B-Cell Lymphoma Stage IV, Neoplasm Progression, Febrile Neutropenia, Bacterial Test Positive, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisone
    Dosage: 500 mg

Cyclophosphamide
    Dosage: 1350 mg

Vincristine Sulfate
    Dosage: 0 mg

Doxil
    Dosage: 72 mg

Rituximab (Moab C2b8 Anti Cd20, Chimeric)
    Dosage: 675 mg



Possible Doxil side effects in female

Reported by a individual with unspecified qualification from United States on 2012-05-08

Patient: female, weighing 40.5 kg (89.1 pounds)

Reactions: Vomiting, Dyspnoea, Chest Discomfort, Lactobacillus Infection, Nausea, Device Related Infection, Pyrexia, Diarrhoea, Staphylococcal Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1028 mg

Doxil
    Dosage: 55 mg

Vincristine Sulfate
    Dosage: 1.9 mg

Prednisone
    Dosage: 500 mg

Rituximab (Moab C2b8 Anti Cd20, Chimeric)
    Dosage: 514 mg



Possible Doxil side effects in 57 year old female

Reported by a physician from United States on 2012-05-04

Patient: 57 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Off Label Use, Hospitalisation, Angiosarcoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil

Other drugs received by patient: Cardiac Medications; Blood Thinners



Possible Doxil side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-30

Patient: female

Reactions: Mucosal Inflammation, Periodontal Infection, Multiple Myeloma, Septic Shock, Renal Failure Chronic

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxil
    Dosage: unk
    Indication: Multiple Myeloma
    Start date: 2011-04-21

Dexamethasone Sodium Phosphate
    Dosage: 20 mg, cyclic
    Indication: Multiple Myeloma
    Start date: 2011-04-04
    End date: 2011-07-13

Velcade
    Dosage: 1.6 mg/m2, cyclic
    Indication: Multiple Myeloma
    Start date: 2011-04-12
    End date: 2011-07-13

Other drugs received by patient: Renalvite; Renvela; Amlodipine; Vancomycin; Triamterene and Hydrochlorothiazid; Lortab; Hydrocodone; Colace; Clindamycin



Possible Doxil side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27

Patient: male, weighing 64.9 kg (142.7 pounds)

Reactions: Hyperproteinaemia, Sepsis, Aortic Aneurysm, Multiple Myeloma, Asthenia, Failure To Thrive, Cerebral Ischaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Multiple Myeloma
    Start date: 2010-07-01
    End date: 2010-08-04

Doxil
    Indication: Multiple Myeloma

Other drugs received by patient: Mucinex; Miralax; Zofran; Norvasc; Flomax; Zestril; Flomax; Zestril; Ambien; Apresoline; Prilosec; Lortab; Lopurin; Centrum Silver / 01292501 /; Cortef / 00028601 /; Ativan; Avodart; MS Contin



Possible Doxil side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: female, weighing 56.4 kg (124.1 pounds)

Reactions: Duodenal Ulcer Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Multiple Myeloma
    Start date: 2011-04-15
    End date: 2011-05-09

Doxil
    Dosage: 30 mg/m2, cyclic
    Indication: Multiple Myeloma
    Start date: 2011-04-15

Dexamethasone
    Dosage: 40 mg, cyclic
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-04-15

Other drugs received by patient: Bactrim DS; Acyclovir; Aloxi; Compazine; Fluconazole

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