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Omnipred (Prednisolone Ophthalmic) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Omnipred (Prednisolone 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 (10)

Reports by Reaction Type

Toxic Anterior Segment Syndrome (7)Drug Ineffective (3)Eye Oedema (3)Intraocular Pressure Increased (3)Vision Blurred (3)Visual Acuity Reduced (2)Off Label Use (2)Pain (1)Post Procedural Complication (1)Cataract Operation Complication (1)Polyarthritis (1)

Possible Omnipred side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30

Patient: 68 year old female

Reactions: Drug Ineffective, Cataract Operation Complication, Eye Oedema, Intraocular Pressure Increased, Vision Blurred, Polyarthritis

Drug(s) suspected as cause:
Celebrex
    Dosage: 200 mg; qd
    Indication: Polyarthritis

Acetazolamide
    Dosage: 125 mg;qd
    Indication: Eye Oedema

Ketorolac Tromethamine
    Dosage: oph
    Indication: Eye Oedema

Tobramycin
    Dosage: oph
    Indication: Eye Oedema
    End date: 2011-10-01

Omnipred
    Dosage: oph
    Administration route: Oral
    Indication: Eye Oedema

Propylene Glycol
    Dosage: oph
    Indication: Eye Oedema

Naproxen
    Indication: Polyarthritis
    End date: 2011-12-01

Simvastatin
    Indication: Blood Cholesterol Increased
    End date: 2011-10-01

Cortisone
    Dosage: qid
    Indication: Eye Oedema
    Start date: 2011-05-01

Lipitor
    Dosage: 20 mg;qd;po
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2011-10-01

Pred Forte
    Dosage: oph
    Indication: Eye Oedema

Other drugs received by patient: Thiazide; Levoxyl



Possible Omnipred side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22

Patient: 68 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Drug Ineffective, Pain, Eye Oedema, Intraocular Pressure Increased, Visual Acuity Reduced, Vision Blurred

Drug(s) suspected as cause:
Pred Forte
    Indication: Eye Oedema

Tobramycin
    Indication: Eye Oedema

Propylene Glycol
    Indication: Eye Oedema

Naproxen
    Indication: Arthritis
    End date: 2011-12-01

Simvastatin
    Indication: Blood Cholesterol Increased
    End date: 2011-10-01

Lipitor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Naproxen
    End date: 2011-12-01

Celebrex
    Indication: Polyarthritis

Acetazolamide
    Indication: Eye Oedema

Ketorolac Tromethamine
    Indication: Eye Oedema

Omnipred
    Indication: Eye Oedema

Cortisone Acetate
    Indication: Eye Oedema
    Start date: 2011-05-01

Other drugs received by patient: Thiazide; Levoxyl



Possible Omnipred side effects in 68 year old female

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

Patient: 68 year old female, weighing 90.7 kg (199.6 pounds)

Reactions: Drug Ineffective, Eye Oedema, Intraocular Pressure Increased, Visual Acuity Reduced, Vision Blurred

Drug(s) suspected as cause:
Naproxen
    Indication: Arthritis
    End date: 2011-12-01

Simvastatin
    Indication: Blood Cholesterol Increased
    End date: 2011-10-01

Cortisone Acetate
    Indication: Eye Oedema
    Start date: 2011-05-01

Celebrex
    Indication: Polyarthritis

Ketorolac Tromethamine
    Indication: Eye Oedema

Propylene Glycol
    Indication: Eye Oedema

Pred Forte
    Indication: Eye Oedema

Tobramycin
    Indication: Eye Oedema

Acetazolamide
    Indication: Eye Oedema

Lipitor
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Omnipred
    Indication: Eye Oedema

Other drugs received by patient: Levoxyl; Thiazide



Possible Omnipred side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-25

Patient: 66 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Off Label Use, Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
Tetracaine Polygyl Sterile Ophthalmic Solution
    Dosage: (ophthalmic)
    Start date: 2011-10-14
    End date: 2011-10-14

Omnipred
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Nevanac
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS

BSS
    Dosage: (intraocular) ; (intraocular)
    Indication: Cataract Operation
    Start date: 2011-10-14
    End date: 2011-10-14

BSS
    Dosage: (intraocular) ; (intraocular)
    Indication: Cataract Operation
    Start date: 2011-10-14
    End date: 2011-10-14

Vigamox
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Other drugs received by patient: Povidone Iodine



Possible Omnipred side effects in 70 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-25

Patient: 70 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Off Label Use, Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
Nevanac
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS
    Dosage: (intraocular) ; (intraocular)
    Indication: Cataract Operation
    Start date: 2011-11-15
    End date: 2011-11-15

BSS
    Dosage: (intraocular) ; (intraocular)
    Indication: Cataract Operation
    Start date: 2011-11-15
    End date: 2011-11-15

Tetracaine Polygyl Sterile Ophthalmic Solution
    Dosage: (ophthalmic)
    Indication: Cataract Operation
    Start date: 2011-11-15
    End date: 2011-11-15

Omnipred
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS

Vigamox
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Other drugs received by patient: Povidone Iodine



Possible Omnipred side effects in 78 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-25

Patient: 78 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Post Procedural Complication, Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
Nevanac
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS
    Dosage: (intraocular), ((intraocular)
    Indication: Cataract Operation
    Start date: 2011-10-21
    End date: 2011-10-21

BSS
    Dosage: (intraocular), ((intraocular)
    Indication: Cataract Operation
    Start date: 2011-10-21
    End date: 2011-10-21

BSS

Vigamox
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Omnipred
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Tetracaine Polygyl Sterile Ophthalmic Solution
    Dosage: (ophthalmic)
    Indication: Cataract Operation
    Start date: 2011-10-21
    End date: 2011-10-21

Other drugs received by patient: Povidone Iodine



Possible Omnipred side effects in 70 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-27

Patient: 70 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
BSS

Nevanac
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Vigamox
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS
    Dosage: (intraocular), (intraocular)
    Indication: Cataract Operation
    Start date: 2011-11-15
    End date: 2011-11-15

BSS
    Dosage: (intraocular), (intraocular)
    Indication: Cataract Operation
    Start date: 2011-11-15
    End date: 2011-11-15

Omnipred
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Tetracaine Polygyl Sterile Ophthalmic Solution
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Other drugs received by patient: Betadine



Possible Omnipred side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-27

Patient: 66 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
BSS

Omnipred
    Dosage: ophthalmic
    Indication: Cataract Operation

Tetracaine Polygyl Sterile Ophthalmic Solution
    Dosage: ophthalmic
    Indication: Cataract Operation

BSS
    Dosage: intraocular
    Indication: Cataract Operation
    Start date: 2011-10-14
    End date: 2011-10-14

BSS
    Dosage: intraocular
    Indication: Cataract Operation
    Start date: 2011-10-14
    End date: 2011-10-14

Nevanac
    Dosage: ophthalmic
    Indication: Cataract Operation

Vigamox
    Dosage: ophthalmic
    Indication: Cataract Operation

Other drugs received by patient: Betadine



Possible Omnipred side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-02

Patient:

Reactions: Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
Vigamox
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Nevanac
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS
    Start date: 2011-10-14
    End date: 2011-10-14

BSS
    Dosage: (intraocular), (intraocular)
    Indication: Cataract Operation
    Start date: 2011-10-14
    End date: 2011-10-14

Omnipred
    Dosage: (ophthalmic)
    Indication: Cataract Operation



Possible Omnipred side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-02

Patient:

Reactions: Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
Vigamox
    Dosage: (ophthalmic)
    Indication: Cataract Operation

Nevanac
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS
    Dosage: (intraocular)
    Start date: 2011-11-15
    End date: 2011-11-15

Omnipred
    Dosage: (ophthalmic)
    Indication: Cataract Operation

BSS
    Dosage: (intraocular)
    Indication: Cataract Operation
    Start date: 2011-11-15
    End date: 2011-11-15

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