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Tobrex (Tobramycin Ophthalmic) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tobrex (Tobramycin 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 (7)

Reports by Reaction Type

Wrong Drug Administered (3)Anterior Chamber Cell (2)Conjunctival Hyperaemia (2)Swelling Face (2)Uveitis (2)Dermatitis Allergic (1)Device Material Issue (1)Post Procedural Complication (1)Anaphylactic Shock (1)Disease Progression (1)Photophobia (1)Dyspnoea (1)

Possible Tobrex side effects in 4 year old female

Reported by a health professional (non-physician/pharmacist) from Czech Republic on 2012-05-31

Patient: 4 year old female

Reactions: Dermatitis Allergic, Swelling Face, Drug Hypersensitivity, Rash Maculo-Papular, Rash Pruritic, Blister

Drug(s) suspected as cause:
Tobrex

Other drugs received by patient: Otobacid N



Possible Tobrex side effects in 82 year old female

Reported by a physician from Australia on 2012-03-15

Patient: 82 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Medication Error, Post Procedural Complication, Toxic Anterior Segment Syndrome

Drug(s) suspected as cause:
BSS Plus
    Dosage: intraocular
    Indication: Intraocular Lens Implant
    Start date: 2011-09-07
    End date: 2011-09-07

Tobrex
    Dosage: ophthalmic
    Indication: Intraocular Lens Implant
    Start date: 2011-09-07
    End date: 2011-09-07

Other drugs received by patient: Cefazolin



Possible Tobrex side effects in 24 month old male

Reported by a physician from Israel on 2012-02-06

Patient: 24 month old male, weighing 12.0 kg (26.4 pounds)

Reactions: Swelling Face, Pneumonia, Dyspnoea, Anaphylactic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobrex

Other drugs received by patient: Syntomycin



Possible Tobrex side effects in 1 month old

Reported by a physician from United States on 2012-02-03

Patient: 1 month old

Reactions: Wrong Drug Administered, Corneal Graft Rejection, Corneal Thickening, Corneal Opacity, Corneal Oedema, Disease Progression

Drug(s) suspected as cause:
Tobrex
    Dosage: daily ophthalmic

Tobradex
    Dosage: daily ophthalmic

Other drugs received by patient: Homatropine Hydrobromide



Possible Tobrex side effects in 65 year old male

Reported by a physician from Turkey on 2012-02-03

Patient: 65 year old male

Reactions: Wrong Drug Administered, Conjunctival Hyperaemia, Anterior Chamber Cell, Uveitis

Drug(s) suspected as cause:
Tobrex
    Dosage: (every 2 hours ophthalmic)

Tobradex
    Dosage: (ophthalmic)



Possible Tobrex side effects in 55 year old female

Reported by a physician from Turkey on 2012-02-03

Patient: 55 year old female

Reactions: Device Material Issue, Hypopyon, Photophobia, Conjunctival Hyperaemia, Wrong Drug Administered, Anterior Chamber Cell, Uveitis

Drug(s) suspected as cause:
Tobrex
    Dosage: (every 2 hours ophthalmic)

Tobradex
    Dosage: (ophthalmic)



Possible Tobrex side effects in 8 month old male

Reported by a health professional (non-physician/pharmacist) from Greece on 2011-10-28

Patient: 8 month old male

Reactions: Ocular Hyperaemia, Ophthalmia Neonatorum, Condition Aggravated

Drug(s) suspected as cause:
Tobrex

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