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Foscarnet (Foscarnet) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Foscarnet 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 (25)
Death (18)
Life Threatening Events (1)

Reports by Reaction Type

Encephalitis Cytomegalovirus (8)Nephropathy Toxic (7)Hydrocephalus (5)Death (4)Pneumonia (4)Neurological Decompensation (4)Cytomegalovirus Viraemia (3)Disorientation (3)Multi-Organ Failure (3)Renal Abscess (3)Pancytopenia (3)Cytomegalovirus Infection (3)

Possible Foscarnet side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-24

Patient: 34 year old female

Reactions: Drug Resistance, Cytomegalovirus Viraemia

Drug(s) suspected as cause:
Prednisolone
    Dosage: 20 mg, bid
    Administration route: Oral
    Indication: Transplant Rejection

Foscarnet
    Dosage: unk
    Indication: Cytomegalovirus Viraemia

Leflunomide
    Dosage: 20 mg, daily maintenance
    Indication: Cytomegalovirus Viraemia

Ganciclovir
    Dosage: unk
    Indication: Cytomegalovirus Viraemia

Methylprednisolone
    Dosage: 500 mg, unk
    Indication: Transplant Rejection

Leflunomide
    Dosage: 100 mg, unk

Tacrolimus
    Dosage: unk
    Indication: Immunosuppression

Valganciclovir
    Dosage: 900 mg, daily
    Administration route: Oral
    Indication: Antiviral Prophylaxis

Cidofovir
    Dosage: unk
    Indication: Cytomegalovirus Viraemia



Possible Foscarnet side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-03

Patient: female

Reactions: Multi-Organ Failure, Septic Shock, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Foscarnet



Possible Foscarnet side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-28

Patient: female

Reactions: Cytomegalovirus Viraemia, Cytomegalovirus Infection, Peripheral Sensory Neuropathy, Pathogen Resistance

Drug(s) suspected as cause:
Valganciclovir
    Dosage: 900mg daily for 5m
    Administration route: Oral
    Indication: Antiviral Prophylaxis

Ganciclovir
    Indication: Cytomegalovirus Viraemia

Tacrolimus
    Indication: Immunosuppressant Drug Therapy

Leflunomide
    Dosage: 20mg daily maintenance

Campath
    Dosage: on d8, 12 of admission
    Indication: Transplant Rejection

Leflunomide
    Dosage: 100mg daily for 3d; then 20mg daily
    Indication: Cytomegalovirus Viraemia

Methylprednisolone
    Dosage: 500mg daily
    Indication: Transplant Rejection

Valganciclovir
    Administration route: Oral

Prednisolone
    Administration route: Oral
    Indication: Transplant Rejection

Cidofovir
    Dosage: received 3 doses
    Indication: Cytomegalovirus Viraemia

Foscarnet
    Indication: Cytomegalovirus Viraemia



Possible Foscarnet side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Histiocytosis Haematophagic, Intestinal Perforation, Pancytopenia, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Ganciclovir
    Indication: Cytomegalovirus Infection

Mycophenolate Mofetil
    Indication: Liver Transplant

Foscarnet
    Indication: Cytomegalovirus Infection

Tacrolimus
    Indication: Liver Transplant

Other drugs received by patient: Steroid



Possible Foscarnet side effects in 65 year old male

Reported by a physician from United States on 2012-04-17

Patient: 65 year old male

Reactions: Encephalitis Cytomegalovirus, Graft Versus Host Disease, Central Nervous System Lesion, Panencephalitis, CNS Ventriculitis

Adverse event resulted in: death, hospitalization

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

Thiotepa
    Indication: Myeloid Leukaemia

Thiotepa
    Indication: Myelodysplastic Syndrome

Rituximab
    Indication: Diffuse Large B-Cell Lymphoma

Rituximab
    Indication: Myeloid Leukaemia

Rituximab
    Indication: Myelodysplastic Syndrome

Idarubicin HCL
    Indication: Diffuse Large B-Cell Lymphoma

Idarubicin HCL
    Indication: Myelodysplastic Syndrome

Idarubicin HCL
    Indication: Myeloid Leukaemia

Fludarabine Phosphate
    Indication: Diffuse Large B-Cell Lymphoma

Fludarabine Phosphate
    Indication: Myelodysplastic Syndrome

Fludarabine Phosphate
    Indication: Myeloid Leukaemia

Etoposide
    Indication: Diffuse Large B-Cell Lymphoma

Etoposide
    Indication: Myelodysplastic Syndrome

Etoposide
    Indication: Myeloid Leukaemia

Valaciclovir
    Indication: Myeloid Leukaemia

Valaciclovir
    Indication: Cytomegalovirus Infection

Valaciclovir
    Indication: Myelodysplastic Syndrome

Depocyt
    Indication: Diffuse Large B-Cell Lymphoma

Depocyt
    Indication: Myelodysplastic Syndrome

Depocyt
    Indication: Myeloid Leukaemia

Mitoxantrone
    Indication: Myelodysplastic Syndrome

Mitoxantrone
    Indication: Myeloid Leukaemia

Mitoxantrone
    Indication: Diffuse Large B-Cell Lymphoma

Anti-Thymocyte Globulin Equine NOS
    Indication: Diffuse Large B-Cell Lymphoma

Anti-Thymocyte Globulin Equine NOS
    Indication: Myelodysplastic Syndrome

Anti-Thymocyte Globulin Equine NOS
    Indication: Myeloid Leukaemia

Foscarnet
    Indication: Myelodysplastic Syndrome

Foscarnet
    Indication: Cytomegalovirus Infection

Foscarnet
    Indication: Myeloid Leukaemia

Acyclovir
    Indication: Myeloid Leukaemia

Acyclovir
    Indication: Cytomegalovirus Infection

Acyclovir
    Indication: Myelodysplastic Syndrome



Possible Foscarnet side effects in 41 year old male

Reported by a individual with unspecified qualification from United Kingdom on 2012-04-10

Patient: 41 year old male

Reactions: Neurological Decompensation, Nephropathy Toxic, Acute Leukaemia, Encephalitis, Disorientation, Disease Progression, Renal Failure, Memory Impairment

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet
    Dosage: 60, mg/kg milligram(s)/kilogram, 1,1, days, intravenous (not otherwise specified)
    Indication: Cytomegalovirus Viraemia

Foscarnet
    Dosage: 90, mg/kg milligram(s)/kilogram, 1. 12 hoursintravenous (not otherwise specified)
    Indication: Cytomegalovirus Viraemia

Foscarnet
    Dosage: 60, mg/kg milligram(s)/kilogram 1, 12, hours , intravenous (not otherwise specified)
    Indication: Encephalitis Cytomegalovirus

Other drugs received by patient: Prednisone TAB; Cidofovir; Fludarabine Phosphate; Cyclosporine; Anti-Thymocyte Globulin NOS; Ganciclovir; Cyclophosphamide - Coated Tablet / Cyclophosphamide; Mycophenolate Mofetil; Valganciclovir HCL; Immunoglobulin / Immunoglobulins



Possible Foscarnet side effects in 6 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-04-10

Patient: 6 year old female

Reactions: Gastrointestinal Haemorrhage, Creatinine Renal Clearance Decreased, Necrosis, Abscess Fungal, Cytomegalovirus Viraemia, Headache, Pyrexia, Multi-Organ Failure, Abdominal Distension, Circulatory Collapse, Hydrocephalus, Immunosuppression, White Blood Cell Count Decreased, Pneumonia, Renal Abscess, Pancytopenia, Grand MAL Convulsion, Disease Recurrence, Acute Sinusitis, Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet
    Dosage: 90, mg/kg milligram(s)/kilogram, 1, 2, weeks
    Indication: Encephalitis Cytomegalovirus

Foscarnet
    Indication: Encephalitis Cytomegalovirus

Foscarnet
    Dosage: 60, mg/kg milligram(s)/kilogram, 1, 8, hours
    Indication: Encephalitis Cytomegalovirus

Other drugs received by patient: Gamma Globuline; Cidofovir - Concentrate FOR Solution FOR Infusion / Cidofovir; Probenecid - Tablet: Oral / Probenecid; Human Cytomegalovirus Immunoglobulins - Solution FOR Infusion / Granul; Ganciclovir



Possible Foscarnet side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-10

Patient: 6 year old female

Reactions: Pneumonia, Fungal Sepsis, Hydrocephalus

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet
    Dosage: 90, mg/kg milligram(s)/kilogram, ,?, unspecified interval
    Indication: Cytomegalovirus Viraemia

Foscarnet
    Dosage: 90, mg/kg milligram(s)/kilogram, ,?, unspecified interval
    Indication: Cytomegalovirus Viraemia

Other drugs received by patient: Methylprednisolone - Cream / Methylprednisolone; Ganciclovir; Cidofovir - Concentrate FOR Solution FOR Infusion / Cidofovir; Monoclonal Antibodies, Granulocyte; Ganciclovir



Possible Foscarnet side effects in 48 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-29

Patient: 48 year old female

Reactions: Encephalitis Cytomegalovirus, Nephropathy Toxic, Retinitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet



Possible Foscarnet side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from Israel on 2012-03-29

Patient: 54 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet

Other drugs received by patient: Ganciclovir



Possible Foscarnet side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-21

Patient: 55 year old male

Reactions: Weight Decreased, Death, Neurological Decompensation, Nephropathy Toxic, Brain Stem Infarction, Graft Versus Host Disease in Intestine, Lethargy

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Foscarnet

Foscarnet
    Indication: Encephalitis Cytomegalovirus

Foscarnet
    Indication: Cytomegalovirus Viraemia

Foscarnet

Other drugs received by patient: Prednisolone; Ganciclovir; Anti-Thymocyte Globulin NOS; Mycophenolate Mofetil; Cyclosporine; Ganciclovir; Ganciclovir; Ganciclovir; Fludarabine Phosphate; Immunoglobulins; Busulfan; Ganciclovir; Cidofovir



Possible Foscarnet side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-21

Patient: 6 year old female

Reactions: Encephalitis Cytomegalovirus, Pneumonia, Abscess Fungal, Fungal Sepsis, Renal Abscess, Hydrocephalus

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Foscarnet

Other drugs received by patient: Thiotepa; Corticosteroids NOS; Methylprednisolone; Immunoglobulins; Ganciclovir; Rabbit Anti-Human Thymocyte Immunoglobulin; Ganciclovir; Cyclophosphamide; Monoclonal Antibodies, Granulocyte; Cidofovir



Possible Foscarnet side effects in 41 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-21

Patient: 41 year old male

Reactions: Death, Renal Failure, Neurological Decompensation, Nephropathy Toxic, Encephalitis, Disorientation, Memory Impairment

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Foscarnet

Foscarnet
    Indication: Cytomegalovirus Viraemia

Foscarnet
    Indication: Encephalitis Cytomegalovirus

Foscarnet

Foscarnet

Foscarnet

Foscarnet

Foscarnet

Other drugs received by patient: Anti-Thymocyte Globulin NOS; Immunoglobulins; Cidofovir; Ganciclovir; Cyclosporine; Prednisone; Valganciclovir; Fludarabine Phosphate; Ganciclovir; Mycophenolate Mofetil; Prednisone; Cyclophosphamide



Possible Foscarnet side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-21

Patient: 65 year old male

Reactions: Neurological Decompensation, General Physical Health Deterioration, Disorientation, Epilepsy, Encephalitis Cytomegalovirus, Nervous System Disorder, Disturbance in Attention, Hydrocephalus, Lethargy, CNS Ventriculitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Foscarnet

Other drugs received by patient: Acyclovir Actavis; Mitoxantrone; Rituximab; Rabit Anti-Human Thymocyte Immunoglobulin; Valaciclovir; Etoposide; Idarubicin HCL; Cytarabine; Thiotepa; Fludarabine Phosphate



Possible Foscarnet side effects in 6 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-20

Patient: 6 year old female

Reactions: White Blood Cell Count Decreased, Gastrointestinal Haemorrhage, Creatinine Renal Clearance Decreased, Pneumonia, Renal Abscess, Pancytopenia, Headache, Pyrexia, Multi-Organ Failure, Grand MAL Convulsion, Acute Sinusitis, Circulatory Collapse, Abdominal Distension, Hydrocephalus, Hypertension, Immunosuppression

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Foscarnet
    Indication: Encephalitis Cytomegalovirus

Foscarnet

Foscarnet

Other drugs received by patient: Ganciclovir; Gamma Globuline; Cidofovir; Ganciclovir; Ganciclovir; Probenecid; Human Cytomegalovirus Immunoglobulins; Cidofovir; Granulocyte Macrophage Colony Stim Factor



Possible Foscarnet side effects in 48 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-19

Patient: 48 year old female

Reactions: Encephalitis Cytomegalovirus, Cytomegalovirus Chorioretinitis, Nephropathy Toxic

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Foscarnet

Other drugs received by patient: ATG Fresenius; Ganciclovir; Prednisolone; Ganciclovir; Mycophenolate Mofetil; Ganciclovir; Ganciclovir



Possible Foscarnet side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-19

Patient: 54 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet

Other drugs received by patient: Fludarabine Phosphate; Neupogen; Ganciclovir; Melphalan Hydrochloride; Thiotepa



Possible Foscarnet side effects in 30 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-19

Patient: 30 year old female

Reactions: Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet
    Indication: Cytomegalovirus Infection

Immune Globulin NOS
    Indication: Cytomegalovirus Infection

Ganciclovir
    Indication: Cytomegalovirus Infection

Other drugs received by patient: Steroid NOS; Fludarabine Phosphate; Thiotepa; Anti-Thymocyte Globulin NOS



Possible Foscarnet side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-14

Patient: 55 year old male

Reactions: Confusional State, Encephalitis Cytomegalovirus, Monoparesis, Muscular Weakness, Sensory Loss, Hyporeflexia, Urinary Retention, Radiculopathy, Paraesthesia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Foscarnet

Other drugs received by patient: Melphalan Hydrochloride; Thiotepa; Immunoglobulin A / Immunoglobulins; Atgam; Immune Globulin Intravenous (Human); Fludarabine Phosphate



Possible Foscarnet side effects in 28 year old female

Reported by a individual with unspecified qualification from Japan on 2012-02-13

Patient: 28 year old female

Reactions: Encephalitis Cytomegalovirus

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet
    Dosage: unspecified unit, unspecified interval
    Indication: Encephalitis Cytomegalovirus

Ganciclovir
    Dosage: unspecified unit, unspecified interval
    Indication: Encephalitis Cytomegalovirus



Possible Foscarnet side effects in 28 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-03

Patient: 28 year old female

Reactions: Encephalitis Cytomegalovirus

Adverse event resulted in: death

Drug(s) suspected as cause:
Foscarnet
    Indication: Encephalitis Cytomegalovirus

Ganciclovir
    Indication: Encephalitis Cytomegalovirus



Possible Foscarnet side effects in 34 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2012-01-18

Patient: 34 year old female

Reactions: Neuropathy Peripheral, Immune Reconstitution Syndrome, Nephropathy Toxic

Drug(s) suspected as cause:
Foscarnet
    Dosage: unk/ reintroduced, intravenous (not otherwise specified) formulation: solution
    Indication: Pneumonitis

Foscarnet
    Dosage: unk/ reintroduced, intravenous (not otherwise specified) formulation: solution
    Indication: Cytomegalovirus Infection



Possible Foscarnet side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-05

Patient: 34 year old female

Reactions: Neuropathy Peripheral, Nephropathy Toxic

Drug(s) suspected as cause:
Foscarnet
    Indication: Cytomegalovirus Infection

Foscarnet
    Dosage: reintroduced

Foscarnet
    Dosage: reintroduced

Foscarnet
    Indication: Pneumonitis



Possible Foscarnet side effects in 15 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-22

Patient: 15 year old female

Reactions: Potentiating Drug Interaction, Oesophagitis Ulcerative, Oesophagitis Haemorrhagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Foscarnet
    Dosage: 80 mg/kg daily
    Indication: Cytomegalovirus Infection

Mycophenolate Mofetil
    Administration route: Oral
    Indication: Graft Versus Host Disease

Other drugs received by patient: Omeprazole; Nicardipine HCL; Cotrim; Voriconazole; Phenoxymethylpenicillin; Deferoxamine Mesylate; Prednisolone



Possible Foscarnet side effects in 15 year old female

Reported by a physician from France on 2011-12-14

Patient: 15 year old female

Reactions: Oesophagitis Ulcerative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycophenolate Mofetil
    Administration route: Oral
    Indication: Graft Versus Host Disease

Foscarnet
    Indication: Cytomegalovirus Infection

Other drugs received by patient: Phenoxymethyl Penicillin; Nicardipine HCL; Omeprazole; Deferoxamine Mesylate; Prednisolone Sodium Sulfate; Cotrim; Voriconazole

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