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Combigan (Brimonidine / Timolol Ophthalmic) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Combigan (Brimonidine / Timolol 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 (147)
Death (3)
Disability (2)

Reports by Reaction Type

Ocular Hyperaemia (27)Eye Irritation (23)Eye Pruritus (17)Eye Pain (15)Dizziness (11)Headache (9)Hypersensitivity (8)Erythema of Eyelid (8)Vision Blurred (8)Dyspnoea (7)Lacrimation Increased (7)Erythema (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Combigan (Brimonidine / Timolol Ophthalmic). For a complete list or a specific selection of reports, please use the links above.

Possible Combigan side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Ventricular Extrasystoles

Drug(s) suspected as cause:
Combigan



Possible Combigan side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Dizziness, Disorientation

Drug(s) suspected as cause:
Combigan



Possible Combigan side effects in 60 year old male

Reported by a consumer/non-health professional from Brazil on 2012-08-10

Patient: 60 year old male

Reactions: Hallucination, Visual, Memory Impairment, Loss of Consciousness

Drug(s) suspected as cause:
Combigan



Possible Combigan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Burning Sensation, Erythema of Eyelid, Ocular Hyperaemia, DRY Skin, Eye Pruritus

Drug(s) suspected as cause:
Combigan
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Lumigan
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Combigan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Hair Growth Abnormal, Erythema, Pregnancy

Drug(s) suspected as cause:
Combigan
    Indication: Product Used FOR Unknown Indication

Lumigan
    Indication: Product Used FOR Unknown Indication



Possible Combigan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Ocular Hyperaemia

Drug(s) suspected as cause:
Combigan
    Dosage: unk
    Indication: Glaucoma

Lumigan
    Indication: Glaucoma



Possible Combigan side effects in 87 year old male

Reported by a physician from United States on 2012-07-30

Patient: 87 year old male

Reactions: Erythema of Eyelid, Eyelid Skin Dryness, Eyelid Irritation, Eyelid Exfoliation

Drug(s) suspected as cause:
Combigan
    Dosage: 2 gtt, bid
    Indication: Glaucoma
    Start date: 2010-01-01

Lumigan
    Dosage: 2 gtt, qhs
    Indication: Glaucoma
    Start date: 2010-01-01



Possible Combigan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Hypoaesthesia Oral, Heart Rate Increased

Drug(s) suspected as cause:
Combigan
    Indication: Product Used FOR Unknown Indication

Lumigan
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Combigan side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 69 year old female

Reactions: Eye Pruritus

Drug(s) suspected as cause:
Combigan
    Indication: Product Used FOR Unknown Indication

Lumigan
    Indication: Product Used FOR Unknown Indication

Trusopt
    Indication: Product Used FOR Unknown Indication



Possible Combigan side effects in female

Reported by a physician from United States on 2012-07-30

Patient: female

Reactions: Dermatitis Contact, Conjunctivitis Allergic

Drug(s) suspected as cause:
Azopt

Combigan
    Indication: Product Used FOR Unknown Indication

Lumigan
    Indication: Product Used FOR Unknown Indication



Possible Combigan side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 73 year old female

Reactions: Skin Discolouration, Ocular Hyperaemia

Drug(s) suspected as cause:
Combigan
    Dosage: 1 gtt, qam
    Indication: Intraocular Pressure Test

Lumigan
    Dosage: 1 gtt, qhs
    Indication: Intraocular Pressure Test



Possible Combigan side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: female

Reactions: Ecchymosis

Drug(s) suspected as cause:
Cascara TAB

Combigan

Coumadin
    Dosage: blue tab



Possible Combigan side effects in

Reported by a physician from United States on 2012-07-11

Patient:

Reactions: Deafness

Drug(s) suspected as cause:
Combigan



Possible Combigan side effects in 79 year old female

Reported by a pharmacist from Spain on 2012-07-06

Patient: 79 year old female

Reactions: Syncope, Sinus Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combigan

Other drugs received by patient: Emeproton 20 MG Capsulas Duras Gastrorresistentes , 14 Capsulas; Indapamida; Xalatan 0,005%, Colirio EN Solucion , 1 Frasco DE 5 ML; Vesicare 5 MG Comprimidos Recubiertos CON Pelicula , 30 Comprimidos; Alphagan 2 MG / ML Colirio EN Solucion , 1 Envase DE 5 ML; Lormetazepam; Duphalac Solucion Oral Sobres , 10 Sobres; Cymbalta 30mg 28 Capsulas Duras



Possible Combigan side effects in 60 year old male

Reported by a consumer/non-health professional from Brazil on 2012-07-03

Patient: 60 year old male

Reactions: Hallucination, Visual, Memory Impairment, Loss of Consciousness

Drug(s) suspected as cause:
Combigan



Possible Combigan side effects in 89 year old female

Reported by a physician from United States on 2012-06-25

Patient: 89 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Confusional State, Incorrect Dose Administered, Swollen Tongue, Speech Disorder, Overdose, DRY Mouth, Dehydration, Bradycardia, Transient Ischaemic Attack, Asthenia, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combigan

Other drugs received by patient: Plavix; Levothyroxine; Travatan Z



Possible Combigan side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-22

Patient: male

Reactions: Hallucination, Visual, Memory Impairment, Loss of Consciousness

Drug(s) suspected as cause:
Combigan



Possible Combigan side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: 44 year old male

Reactions: Dizziness, Headache, Eye Pain

Drug(s) suspected as cause:
Combigan
    Dosage: 1 gtt, bid
    Indication: Glaucoma
    Start date: 2011-12-01
    End date: 2012-01-01

Lumigan
    Dosage: 1 gtt, bid
    Indication: Glaucoma
    Start date: 2011-12-01



Possible Combigan side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: female

Reactions: Burning Sensation, Ocular Hyperaemia

Drug(s) suspected as cause:
Combigan
    Dosage: one drop to each eye, twice per day
    Indication: Intraocular Pressure Test
    Start date: 2012-03-02

Lumigan
    Dosage: one drop to each eye, once at night
    Indication: Intraocular Pressure Test
    Start date: 2012-03-02



Possible Combigan side effects in 68 year old male

Reported by a physician from United States on 2012-06-21

Patient: 68 year old male

Reactions: Eye Irritation, Lacrimation Increased

Drug(s) suspected as cause:
Combigan
    Dosage: 1 gtt, qhs
    Indication: Intraocular Pressure Increased
    Start date: 2007-01-01

Lumigan
    Dosage: 2 gtt, qam
    Indication: Intraocular Pressure Increased



Possible Combigan side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: 66 year old female

Reactions: Eye Irritation, Scleral Hyperaemia, Rash, Eye Disorder, Erythema, Eye Pruritus

Drug(s) suspected as cause:
Combigan
    Dosage: 2 gtt, bid
    Indication: Intraocular Pressure Increased
    Start date: 2012-02-01

Lumigan
    Dosage: 2 gtt, qhs
    Indication: Intraocular Pressure Increased
    Start date: 2012-02-01



Possible Combigan side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Ear Discomfort, Nasal Oedema, Dyspnoea, Swelling, Pain, Ear Pain, Headache

Drug(s) suspected as cause:
Azopt
    Dosage: unk, each eye 1x/day

Combigan
    Dosage: unk, each eye 2x/day

Latanoprost
    Dosage: unk

Lumigan
    Dosage: unk, each eye every night at bed time

Pilocarpine HCL
    Dosage: unk

Xalatan
    Dosage: unk, each eye every night at bed time



Possible Combigan side effects in 77 year old female

Reported by a physician from United States on 2012-06-15

Patient: 77 year old female

Reactions: Coronary Artery Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alphagan P
    Dosage: unk
    Indication: Glaucoma
    Start date: 2011-12-05
    End date: 2012-05-01

Combigan
    Indication: Glaucoma

Other drugs received by patient: Plavix; Lisinopril; Aspirin



Possible Combigan side effects in 42 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: 42 year old male, weighing 111.0 kg (244.2 pounds)

Reactions: Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Combigan
    Dosage: 2 gtt, bid
    Indication: Glaucoma
    Start date: 2010-04-01

Lumigan
    Dosage: 2 gtt, qhs
    Indication: Glaucoma
    Start date: 2005-07-01



Possible Combigan side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-21

Patient: 63 year old male

Reactions: Pain, Localised Oedema, Erythema

Drug(s) suspected as cause:
Azopt
    Dosage: (ophthalmic)
    Start date: 2012-04-17
    End date: 2012-04-23

Combigan
    Dosage: (ophthalmic)
    Start date: 2012-04-17
    End date: 2012-04-23



Possible Combigan side effects in 63 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-05-16

Patient: 63 year old male

Reactions: Local Reaction, Pain, Localised Oedema, Erythema

Drug(s) suspected as cause:
Azopt
    Dosage: unk
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-17
    End date: 2012-04-23

Combigan
    Dosage: unk
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-17
    End date: 2012-04-23



Possible Combigan side effects in 89 year old female

Reported by a physician from United States on 2012-05-11

Patient: 89 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Confusional State, Incorrect Dose Administered, Swollen Tongue, Asthenia, Lethargy

Drug(s) suspected as cause:
Combigan

Other drugs received by patient: Plavix; Levothyroxine Sodium



Possible Combigan side effects in 42 year old male

Reported by a physician from United States on 2012-05-03

Patient: 42 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Combigan
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01

Lumigan
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01



Possible Combigan side effects in female

Reported by a individual with unspecified qualification from United States on 2012-03-26

Patient: female, weighing 49.4 kg (108.8 pounds)

Reactions: Thinking Abnormal, Dizziness, Vertigo, Blindness Unilateral, Disorientation, Cerebrovascular Accident

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Combigan
    Dosage: 2@day

Travatan
    Dosage: 1 @day



Possible Combigan side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-20

Patient: 73 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Swelling Face, Diarrhoea, Headache, Throat Tightness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Combigan

Other drugs received by patient: Timolol Maleate; Zovirax; Azopt; Bendroflumethiazide; Bisoprolol Fumarate; Hypromellose; Amitriptyline HCL; Maxidex

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