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Fluticasone (Fluticasone Topical) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fluticasone (Fluticasone Topical) 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 (10)
Death (2)

Reports by Reaction Type

Polymedication (3)Mental Status Changes (3)Cushing's Syndrome (3)Hypokalaemia (3)Dysarthria (3)Hypertension (3)Condition Aggravated (2)Toxicity To Various Agents (2)Oedema Peripheral (2)Toxic Neuropathy (2)Drug Interaction (1)Headache (1)

Possible Fluticasone side effects in 72 year old male

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

Patient: 72 year old male

Reactions: Oedema Peripheral, Toxic Neuropathy

Adverse event resulted in: hospitalization

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

Albuterol
    Indication: Product Used FOR Unknown Indication

Fluticasone
    Indication: Product Used FOR Unknown Indication

Itraconazole

Itraconazole
    Indication: Aspergillosis



Possible Fluticasone side effects in 72 year old male

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

Patient: 72 year old male

Reactions: Oedema Peripheral, Toxic Neuropathy

Adverse event resulted in: hospitalization

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

Itraconazole
    Indication: Aspergillosis

Albuterol
    Indication: Product Used FOR Unknown Indication

Itraconazole

Fluticasone
    Indication: Product Used FOR Unknown Indication



Possible Fluticasone side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-22

Patient: 60 year old female

Reactions: Cushing's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisolone
    Indication: Lower Respiratory Tract Infection

Kaletra
    Indication: HIV Infection

Triamcinolone Acetonide
    Indication: Arthralgia

Fluticasone
    Indication: Lower Respiratory Tract Infection

Other drugs received by patient: Lamivudine; Amitriptyline HCL; Tramadol HCL; Gabapentin; Methotrexate; Abacavir



Possible Fluticasone side effects in 60 year old female

Reported by a physician from United Kingdom on 2012-06-21

Patient: 60 year old female

Reactions: Cushing's Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kaletra
    Indication: HIV Infection

Fluticasone
    Indication: Lower Respiratory Tract Infection

Prednisolone
    Indication: Lower Respiratory Tract Infection

Triamcinolone Acetonide
    Indication: Arthralgia

Other drugs received by patient: Tramadol HCL; Abacavir; Gabapentin; Methotrexate; Amitriptyline HCL; Lamivudine (Epivir Hbv)



Possible Fluticasone side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-20

Patient: 36 year old female

Reactions: Drug Interaction, Cushing's Syndrome

Drug(s) suspected as cause:
Verapamil HCL
    Dosage: unk
    Indication: Hypertension

Fluticasone
    Dosage: 1500 ug, qd



Possible Fluticasone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-15

Patient: female, weighing 89.4 kg (196.7 pounds)

Reactions: Dysarthria, Polymedication, Mental Status Changes, Headache, Hypertension, Asthenia, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lexapro
    Administration route: Oral
    Indication: Post-Traumatic Stress Disorder

Ambien
    Administration route: Oral
    Indication: Insomnia

Lyrica
    Administration route: Oral
    Indication: Fibromyalgia

Clonazepam
    Administration route: Oral
    Indication: Bipolar Disorder

Ibuprofen
    Administration route: Oral
    Indication: Fibromyalgia

Placebo
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Lexapro
    Administration route: Oral
    Indication: Bipolar Disorder

Robaxin
    Indication: Fibromyalgia

Zestoretic
    Dosage: 20/12.5 daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-12-04

Desvenlafaxine Succinate Monohydrate
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Placebo
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Loratadine
    Administration route: Oral
    Indication: Seasonal Allergy

Vicodin
    Dosage: 5/500 as needed
    Administration route: Oral
    Indication: Fibromyalgia

Vivelle
    Indication: Hormone Replacement Therapy

Desvenlafaxine Succinate Monohydrate
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Abilify
    Administration route: Oral
    Indication: Bipolar I Disorder

Fluticasone
    Indication: Seasonal Allergy



Possible Fluticasone side effects in female

Reported by a physician from United States on 2012-03-13

Patient: female, weighing 89.4 kg (196.7 pounds)

Reactions: Dysarthria, Polymedication, Mental Status Changes, Condition Aggravated, Hypertension, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Dosage: 15 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar I Disorder

Blinded Desvenlafaxine Succinate Monohydrate
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Lexapro
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Post-Traumatic Stress Disorder

Fluticasone
    Dosage: 2 sprays daily route: in
    Indication: Seasonal Allergy

Blinded Placebo
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Fibromyalgia

Robaxin
    Dosage: 750 mg, 3x/day
    Administration route: Oral
    Indication: Fibromyalgia

Clonazepam
    Dosage: 1 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder

Vicodin
    Dosage: 5/500 prn
    Administration route: Oral
    Indication: Fibromyalgia

Blinded Placebo
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Loratadine
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Seasonal Allergy

Robaxin
    Dosage: unknown

Lexapro
    Indication: Bipolar Disorder

Vivelle
    Dosage: 0.1 mg, unk
    Indication: Hormone Replacement Therapy

Ibuprofen
    Dosage: 800 mg, 3x/day
    Administration route: Oral
    Indication: Fibromyalgia

Ambien
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Insomnia

Blinded Desvenlafaxine Succinate Monohydrate
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Blinded NO Subject Drug
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Zestoretic
    Dosage: 20/12.5 daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-12-04

Blinded NO Subject Drug
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24



Possible Fluticasone side effects in 62 year old female

Reported by a physician from United States on 2012-01-23

Patient: 62 year old female

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Mevacor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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

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

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

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

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

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

Metformin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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

Albuterol
    Indication: Product Used FOR Unknown Indication

Docusate Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Iron (Unspecified)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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

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

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

Insulin
    Indication: Product Used FOR Unknown Indication



Possible Fluticasone side effects in 62 year old female

Reported by a physician from United States on 2012-01-11

Patient: 62 year old female

Reactions: Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Pepcid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Docusate Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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

Albuterol
    Indication: Product Used FOR Unknown Indication

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

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

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

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

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

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

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

Insulin
    Indication: Product Used FOR Unknown Indication

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

Iron (Unspecified)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

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



Possible Fluticasone side effects in female

Reported by a physician from United States on 2011-12-16

Patient: female, weighing 89.4 kg (196.7 pounds)

Reactions: Dysarthria, Polymedication, Condition Aggravated, Mental Status Changes, Hypertension, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lexapro
    Dosage: 20 mg, 1x/day

Vivelle
    Dosage: 0.1 mg, unk

Blinded NO Subject Drug
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Blinded Desvenlafaxine Succinate Monohydrate
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Blinded NO Subject Drug
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Blinded Placebo
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Loratadine
    Dosage: 10 mg, 1x/day

Robaxin
    Dosage: unknown

Abilify
    Dosage: 15 mg, 2x/day

Ibuprofen
    Dosage: 800 mg, 3x/day

Clonazepam
    Dosage: 1 mg, 2x/day

Fluticasone
    Dosage: 2 sprays daily

Zestoretic
    Dosage: 20/12.5 daily

Ambien
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Lyrica
    Dosage: 75 mg, 1x/day

Robaxin
    Dosage: 750 mg, 3x/day
    Administration route: Oral

Blinded Placebo
    Dosage: blinded therapy daily
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-09-09
    End date: 2008-11-22

Blinded Desvenlafaxine Succinate Monohydrate
    Dosage: blinded therapy daily
    Administration route: Oral
    Start date: 2008-11-29
    End date: 2008-12-24

Vicodin
    Dosage: 5/500 prn

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