Trusopt (Dorzolamide Hydrochloride Ophthalmic) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Controlled clinical trials: The most frequent adverse reactions associated with TRUSOPT were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. Reactions occurring in approximately 1 to 5% of patients were conjunctivitis and lid reactions [see Warnings and Precautions], blurred vision, eye redness, tearing, dryness, and photophobia. Other ocular reactions and systemic reactions were reported infrequently, including headache, nausea, asthenia/fatigue; and, rarely, skin rashes, urolithiasis, and iridocyclitis.

In a 3-month, double-masked, active-treatment-controlled, multicenter study in pediatric patients, the adverse reactions profile of TRUSOPT was comparable to that seen in adult patients.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of TRUSOPT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: signs and symptoms of systemic allergic reactions including angioedema, bronchospasm, pruritus, and urticaria; Stevens-Johnson syndrome and toxic epidermal necrolysis; dizziness, paresthesia; ocular pain, transient myopia, choroidal detachment following filtration surgery, eyelid crusting; dyspnea; contact dermatitis, epistaxis, dry mouth and throat irritation.

REPORTS OF SUSPECTED TRUSOPT SIDE EFFECTS / ADVERSE REACTIONS

Possible Trusopt side effects / adverse reactions in 87 year old male

Reported by a physician from Japan on 2011-10-04

Patient: 87 year old male

Reactions: Oesophageal Carcinoma

Adverse event resulted in: death

Suspect drug(s):
Trusopt
    Dosage: daily dosage inknown
    Indication: Ocular Hypertension
    Start date: 2008-12-17
    End date: 2010-04-19

Timoptic
    Dosage: daily dosage unknown
    Indication: Glaucoma
    Start date: 2008-12-10
    End date: 2010-04-19

Timoptic
    Dosage: daily dosage unknown
    Indication: Hypertonia
    Start date: 2008-12-10
    End date: 2010-04-19

Trusopt
    Dosage: daily dosage inknown
    Indication: Glaucoma
    Start date: 2008-12-17
    End date: 2010-04-19

Other drugs received by patient: Tapros (Tafluprost)

Possible Trusopt side effects / adverse reactions in 82 year old female

Reported by a consumer/non-health professional from Canada on 2011-10-04

Patient: 82 year old female

Reactions: Diplopia, Amblyopia

Suspect drug(s):
Trusopt
    Dosage: 1 gtt in each eye, 10 min after the latanoprost
    Indication: Prophylaxis
    End date: 2011-01-01

Xalatan
    Dosage: 1 gtt, in both eyes at night, 1x/day
    Indication: Glaucoma
    Start date: 2005-01-01

Other drugs received by patient: Warfarin; Crestor; Verapamil; Cozaar; Warfarin

Possible Trusopt side effects / adverse reactions in 87 year old male

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

Patient: 87 year old male

Reactions: Oesophageal Carcinoma

Adverse event resulted in: death

Suspect drug(s):
Trusopt
    Dosage: both eyes and daily dosage unknown
    Indication: Hypertonia
    Start date: 2008-12-17
    End date: 2010-04-19

Timoptic
    Dosage: both eyes and daily dosage unknown
    Indication: Hypertonia
    Start date: 2008-12-10
    End date: 2010-04-19

Trusopt
    Dosage: both eyes and daily dosage unknown
    Indication: Glaucoma
    Start date: 2008-12-17
    End date: 2010-04-19

Timoptic
    Dosage: both eyes and daily dosage unknown
    Indication: Glaucoma
    Start date: 2008-12-10
    End date: 2010-04-19

Other drugs received by patient: Tapros (Tafluprost)