ADVERSE REACTIONS
In clinical studies the overall discontinuation rate related to IOPIDINE 0.5% Ophthalmic Solution was 15%. The most commonly reported events leading to discontinuation included (in decreasing order of frequency) hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation.
The following adverse reactions (incidences) were reported in clinical studies of IOPIDINE 0.5% (apraclonidine ophthalmic solution) as being possibly, probably, or definitely related to therapy:
Ocular
The following adverse reactions were reported in 5 to 15% of the patients: discomfort, hyperemia, and puritus. The following adverse reactions were reported in 1 to 5% of the patients: blanching, blurred vision, conjunctivitis, discharge, dry eye, foreign body sensation, lid edema, and tearing.
The following adverse reactions were reported in less than 1% of the patients: abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival follicles, corneal erosion, corneal infiltrate, corneal staining, edema, irritation, keratitis, keratopathy, lid disorder, lid erythema, lid margin crusting, lid retraction, lid scales, pain, photophobia.
Nonocular
Dry mouth occurred in approximately 10% of the patients.
The following adverse reactions were reported in less than 3% of the patients: abnormal coordination, asthenia, arrhythmia, asthma, chest pain, constipation, contact dermatitis, depression, dermatitis, dizziness, dry nose, dyspnea, facial edema, headache, insomnia, malaise, myalgia, nausea, nervousness, paresthesia, parosmia, peripheral edema, pharyngitis, rhinitis, somnolence, and taste perversion.
Clinical practice: The following events have been identified during post-marketing use of IOPIDINE® 0.5% Ophthalmic Solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to IOPIDINE 0.5% Ophthalmic Solution, or a combination of these factors, include: bradycardia.
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REPORTS OF SUSPECTED IOPIDINE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Iopidine. The information is not vetted and should not be considered as verified clinical evidence.
Possible Iopidine side effects / adverse reactions in 98 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 98 year old female
Reactions: Malaise, Overdose, Impaired Self-Care, Atrioventricular Block Complete, Condition Aggravated, Bradycardia
Adverse event resulted in: hospitalization
Suspect drug(s):
Duotrav Ophthalmic Solution (Duotrav)
Dosage: once daily ophthalmic
Start date: 2009-01-01
End date: 2011-07-04
Iopidine
Dosage: bid ophthalmic
Start date: 2009-01-01
End date: 2011-07-04
Other drugs received by patient: Calcium Carbonate; Lansoyl; Imovane
Possible Iopidine side effects / adverse reactions in 82 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-11
Patient: 82 year old male
Reactions: Retinal Pigment Epithelial Tear
Suspect drug(s):
Iopidine
Dosage: (bid ophthalmic)
Start date: 2011-02-02
End date: 2011-02-20
Lacrigel (Lacrigel) (Farmigea S.p.a.)
Dosage: (tid)
Start date: 2011-02-02
End date: 2011-02-06
Lucentis
Dosage: )10 mg/ml 1 administration per month)
Indication: AGE-Related Macular Degeneration
Start date: 2011-02-02
Ofloxacin
Dosage: (bid)
Start date: 2011-02-01
End date: 2011-02-06
Other drugs received by patient: Pentoxifylline; Alfuzosin HCL; Permixon
Possible Iopidine side effects / adverse reactions in 85 year old female
Reported by a physician from United Kingdom on 2012-06-13
Patient: 85 year old female
Reactions: Paradoxical Drug Reaction, Intraocular Pressure Increased
Suspect drug(s):
Acetazolamide
Dosage: (500 mg intravenous (not otherwise specified)), (250 mg qid), (125 mg qid)
Indication: Angle Closure Glaucoma
Azopt
Dosage: tid ophthalmic
Indication: Angle Closure Glaucoma
Iopidine
Dosage: tid ophthalmic
Indication: Eye Disorder
Isopto Carpine
Dosage: ophthalmic
Indication: Angle Closure Glaucoma
Pred Forte
Dosage: (qid)
Indication: Angle Closure Glaucoma
Other drugs received by patient: Metoclopramide; Voltaren
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