This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tobradex 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 (28)
Reports by Reaction Type
Lipogranuloma (8),
Off Label Use (7),
Wrong Drug Administered (3),
Ulcerative Keratitis (3),
Anterior Chamber Cell (3),
Conjunctival Hyperaemia (3),
Ocular Hyperaemia (3),
Corneal Perforation (2),
Diplopia (2),
Corneal Opacity (2),
Aqueous Humour Leakage (2),
Uveitis (2)
Possible Tobradex side effects in 42 year old female
Reported by a physician from Switzerland on 2012-08-01
Patient: 42 year old female
Reactions: Endophthalmitis, Scleritis, Eye Infection Bacterial, Ulcerative Keratitis, Treatment Noncompliance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tobradex
Other drugs received by patient: Ciprofloxacin
Possible Tobradex side effects in 65 year old female
Reported by a consumer/non-health professional from Spain on 2012-07-05
Patient: 65 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Increased Insulin Requirement, Blood Glucose Increased
Drug(s) suspected as cause:
Tobradex
Other drugs received by patient: Insulin; Actrapid; Lantus
Possible Tobradex side effects in 57 year old male
Reported by a physician from Switzerland on 2012-06-25
Patient: 57 year old male
Reactions: Amniotic Membrane Graft, Conjunctival Hyperaemia, Post Procedural Complication, Ocular Hyperaemia, Ulcerative Keratitis, Anterior Chamber Cell, Anterior Chamber Fibrin
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mitomycin
Dosage: (0.2 mg/ml for 2 min intraocular)
Indication: Surgery
Ofloxacin
Dosage: (every 2 hours ophthalmic)
Indication: Infection Prophylaxis
Tobradex
Dosage: (tid ophthalmic)
Indication: Postoperative Care
Vitamin A
Dosage: (tid ophthalmic)
Indication: Postoperative Care
Possible Tobradex side effects in female
Reported by a physician from Malta on 2012-06-08
Patient: female
Reactions: Corneal Perforation, Ocular Hyperaemia, Aqueous Humour Leakage, Eye Pain
Drug(s) suspected as cause:
Tobradex
Other drugs received by patient: Cyclosporine; Etanercept
Possible Tobradex side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: male, weighing 88.5 kg (194.6 pounds)
Reactions: Excoriation, Expired Drug Administered, Eye Disorder, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from Poland on 2012-05-21
Patient: 67 year old female, weighing 65.0 kg (143.0 pounds)
Reactions: Mouth Haemorrhage
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 76 year old female
Reported by a physician from Spain on 2012-05-10
Patient: 76 year old female
Reactions: Enterococcus Test Positive, Corneal Opacity, Corneal Leukoma, Infectious Crystalline Keratopathy
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-01
Patient: male, weighing 88.0 kg (193.6 pounds)
Reactions: Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diazepam
Dosage: 5 mg, tid or prn
Administration route: Oral
Indication: Bipolar Disorder
Tobradex
Dosage: unk
Indication: Laceration
Start date: 2012-02-01
Possible Tobradex side effects in female
Reported by a physician from Malta on 2012-05-01
Patient: female
Reactions: Corneal Perforation, Ocular Hyperaemia, Aqueous Humour Leakage, Eye Pain
Drug(s) suspected as cause:
Tobradex
Other drugs received by patient: Cyclosporine; Etanercept
Possible Tobradex side effects in 70 year old female
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: 70 year old female, weighing 64.5 kg (141.9 pounds)
Reactions: Hypersensitivity
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 28 year old female
Reported by a consumer/non-health professional from United States on 2012-03-19
Patient: 28 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Night Sweats, Skin Exfoliation, Insomnia, Rash, Hallucination, Delusion
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 58 year old male
Reported by a individual with unspecified qualification from United States on 2012-03-15
Patient: 58 year old male
Reactions: Diplopia, Vision Blurred
Drug(s) suspected as cause:
Tobradex
Dosage: (1 gtt tid os ophthalmic)
Indication: Postoperative Care
Tobradex ST
Dosage: (3 gtt qd os ophthalmic), (3 gtt qd os ophthalmic)
Indication: Postoperative Care
Tobradex ST
Other drugs received by patient: Simvastatin; Aspirin
Possible Tobradex side effects in 58 year old male
Reported by a consumer/non-health professional from United States on 2012-03-06
Patient: 58 year old male
Reactions: Diplopia, Vision Blurred
Drug(s) suspected as cause:
Tobradex
Dosage: (3 gtt qd os ophthalmic) ; (3 gtt qd os ophthalmic)
Indication: Postoperative Care
Tobradex
Dosage: (1 gtt tid os ophthalmic)
Indication: Postoperative Care
Tobradex
Other drugs received by patient: Aspirin; Simvastatin
Possible Tobradex side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-01
Patient: female, weighing 59.4 kg (130.7 pounds)
Reactions: Economic Problem, Eyelid Oedema, Erythema of Eyelid, Eyelid Bleeding
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in female
Reported by a pharmacist from Cyprus on 2012-02-16
Patient: female
Reactions: Purulence, Eye Swelling, Ulcerative Keratitis, Eye Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tobradex
Possible Tobradex 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:
Tobradex
Dosage: (ophthalmic)
Tobrex
Dosage: (every 2 hours ophthalmic)
Possible Tobradex 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:
Tobradex
Dosage: (ophthalmic)
Tobrex
Dosage: (every 2 hours ophthalmic)
Possible Tobradex 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:
Tobradex
Dosage: daily ophthalmic
Tobrex
Dosage: daily ophthalmic
Other drugs received by patient: Homatropine Hydrobromide
Possible Tobradex side effects in 34 year old male
Reported by a physician from United States on 2011-12-05
Patient: 34 year old male, weighing 74.8 kg (164.7 pounds)
Reactions: Lens Disorder
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 45 year old female
Reported by a physician from China on 2011-12-02
Patient: 45 year old female
Reactions: Off Label Use, Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 48 year old female
Reported by a physician from China on 2011-11-22
Patient: 48 year old female
Reactions: Off Label Use, Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 62 year old female
Reported by a physician from China on 2011-11-22
Patient: 62 year old female
Reactions: Off Label Use, Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 55 year old male
Reported by a physician from China on 2011-11-22
Patient: 55 year old male
Reactions: Off Label Use, Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 45 year old female
Reported by a physician from China on 2011-11-22
Patient: 45 year old female
Reactions: Off Label Use, Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 57 year old male
Reported by a physician from China on 2011-11-22
Patient: 57 year old male
Reactions: Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 51 year old female
Reported by a physician from China on 2011-11-22
Patient: 51 year old female
Reactions: Off Label Use, Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 60 year old male
Reported by a physician from China on 2011-11-22
Patient: 60 year old male
Reactions: Off Label Use, Lipogranuloma
Drug(s) suspected as cause:
Tobradex
Possible Tobradex side effects in 72 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-04
Patient: 72 year old female
Reactions: Blindness Transient, Ocular Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tobradex
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