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Fluorescite (Fluorescein Ophthalmic) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fluorescite (Fluorescein Ophthalmic) 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 (19)
Death (2)
Life Threatening Events (4)
Disability (1)

Reports by Reaction Type

Anaphylactic Shock (6)Nausea (6)Infection (3)Abdominal Pain Upper (3)Conjunctivitis Bacterial (3)Anaphylactoid Reaction (3)Decreased Appetite (3)Stupor (3)Renal Impairment (3)Respiratory Arrest (3)Cardiac Arrest (3)Pyrexia (2)

Possible Fluorescite side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-06-05

Patient: 66 year old male

Reactions: Nausea, Fear, Hypotension, Coma, Anaphylactic Shock, Stupor, Abdominal Pain Upper, Hypoxic-Ischaemic Encephalopathy, Renal Failure, Respiratory Arrest, Cardiac Arrest, Infection

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

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 66 year old male

Reported by a physician from China on 2012-06-01

Patient: 66 year old male

Reactions: Nausea, Fear, Respiratory Arrest, Coma, Anaphylactic Shock, Cardiac Arrest, Stupor, Abdominal Pain Upper

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

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-07

Patient: 67 year old male

Reactions: Malaise, Pulse Absent, Anaphylactic Shock, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 62 year old male

Reported by a physician from Japan on 2012-03-29

Patient: 62 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Renal Failure, Anaphylactic Reaction, Disseminated Intravascular Coagulation, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite

Other drugs received by patient: Mucosta; Pravastatin Sodium; Sennoside; Zolpidem; Magnesium Oxide; Symmetrel; Candesartan Cilexetil; Vesicare; Famotidine; Aspirin; Amlodipine; Actos



Possible Fluorescite side effects in 85 year old female

Reported by a physician from Germany on 2012-03-13

Patient: 85 year old female

Reactions: Off Label Use, Aspiration, Lung Infiltration

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 85 year old female

Reported by a physician from Germany on 2012-02-17

Patient: 85 year old female

Reactions: Off Label Use, Lung Infiltration, Intracranial Hypotension

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 67 year old male

Reported by a physician from Japan on 2012-02-16

Patient: 67 year old male, weighing 67.0 kg (147.4 pounds)

Reactions: Haemophilus Infection, Pyrexia, Angioplasty, Conjunctivitis Bacterial, Renal Impairment, Decreased Appetite, Cough, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite
    Dosage: 250 mg milligram(s), qd, intravenous
    Indication: Diagnostic Procedure
    Start date: 2011-09-15
    End date: 2011-09-15

Pletal
    Dosage: 100 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 2011-09-17
    End date: 2011-09-21

Pletal
    Dosage: 100 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Renal Impairment
    Start date: 2011-09-17
    End date: 2011-09-21

Other drugs received by patient: Newtolide (Hydrochlorothiazide) Tablet; Mucodyne (Carbocisteine); Diovan; Fluvastatin; Atelec (Cilnidipine) Tablet; Cellcept; Neoral; Basen (Voglibose) Orodispersible Tablet



Possible Fluorescite side effects in 83 year old female

Reported by a pharmacist from Canada on 2012-02-16

Patient: 83 year old female

Reactions: Burning Sensation, Syncope, Nausea, Hypotension, Unresponsive To Stimuli, Pulmonary Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 65 year old male

Reported by a physician from China on 2012-02-09

Patient: 65 year old male

Reactions: Nausea, Respiratory Arrest, Anaphylactic Shock, Apparent Life Threatening Event, Cardiac Arrest, Stupor, Abdominal Pain Upper

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 55 year old male

Reported by a physician from Japan on 2012-02-08

Patient: 55 year old male

Reactions: Vomiting, Nausea, Anaphylactic Shock, Ischaemic Hepatitis, Hepatic Infarction, Hepatic Cirrhosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite

Other drugs received by patient: Warfarin Sodium



Possible Fluorescite side effects in 83 year old female

Reported by a pharmacist from Canada on 2012-02-03

Patient: 83 year old female

Reactions: Burning Sensation, Syncope, Nausea, Pulmonary Oedema, Blood Pressure Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-20

Patient: 49 year old female

Reactions: Dermatitis Contact

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

Fluorescite
    Indication: Product Used FOR Unknown Indication

Restasis
    Indication: Product Used FOR Unknown Indication

Xalatan
    Indication: Glaucoma



Possible Fluorescite side effects in 56 year old male

Reported by a physician from Japan on 2012-01-20

Patient: 56 year old male

Reactions: LIP Swelling, Hypoaesthesia Oral, Anaphylactoid Reaction, Urticaria

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 56 year old male

Reported by a physician from Japan on 2012-01-11

Patient: 56 year old male

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Fluorescite



Possible Fluorescite side effects in 56 year old male

Reported by a physician from Japan on 2012-01-10

Patient: 56 year old male

Reactions: Anaphylactoid Reaction

Drug(s) suspected as cause:
Fluorescite

Other drugs received by patient: Stronger NEO Minophagen C; Chlor-Trimeton; Solu-Cortef



Possible Fluorescite side effects in 83 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-23

Patient: 83 year old male

Reactions: Urticaria, Rash

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Fluorescite

Other drugs received by patient: Aspirin



Possible Fluorescite side effects in 67 year old male

Reported by a physician from Japan on 2011-11-02

Patient: 67 year old male, weighing 67.0 kg (147.4 pounds)

Reactions: Haemophilus Infection, Pyrexia, Haemodialysis, Conjunctivitis Bacterial, Renal Impairment, Dehydration, Decreased Appetite, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite
    Dosage: 250 mg milligram(s), qd, intravenous
    Indication: Diagnostic Procedure
    Start date: 2011-09-15
    End date: 2011-09-15

Pletal
    Dosage: 100 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Renal Impairment
    Start date: 2011-09-17
    End date: 2011-09-21

Pletal
    Dosage: 100 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Arteriosclerosis Obliterans
    Start date: 2011-09-17
    End date: 2011-09-21

Other drugs received by patient: Diovan; Neoral; Atelec (Clinidipine); Mucodyne (Carbocisteine); Fluvastatin; Basen (Voglibose); Newtolide (Hydrochlorothiazide); Cellcept



Possible Fluorescite side effects in 67 year old male

Reported by a physician from Japan on 2011-10-25

Patient: 67 year old male, weighing 67.0 kg (147.4 pounds)

Reactions: Transplant Rejection, Upper Respiratory Tract Inflammation, Conjunctivitis Bacterial, Renal Impairment, Dehydration, Decreased Appetite, Cough, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite
    Dosage: intravenous
    Start date: 2011-09-15
    End date: 2011-09-15

Pletal
    Dosage: 100 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Arteriosclerosis Obliterans
    Start date: 2011-09-17
    End date: 2011-09-21

Pletal
    Dosage: 100 mg milligram(s), bid, oral
    Administration route: Oral
    Indication: Renal Impairment
    Start date: 2011-09-17
    End date: 2011-09-21

Other drugs received by patient: Fluvastatin; Diovan; Cellcept; Newtolide (Hydrochlorothiazide); Basen (Voglibose); Mucodyne (Carbocisteine); Atelec (Clinidipine); Neoral



Possible Fluorescite side effects in 55 year old male

Reported by a physician from Japan on 2011-10-24

Patient: 55 year old male

Reactions: Anaphylactic Shock, Ischaemic Hepatitis, Hepatic Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorescite

Other drugs received by patient: Warfarin Sodium

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