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Macugen (Pegaptanib) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Macugen (Pegaptanib) 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 (35)
Death (6)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Visual Acuity Reduced (6)Cerebral Infarction (4)Glaucoma (3)Intraocular Pressure Increased (3)Fall (3)Retinal Haemorrhage (3)Hypertension (3)Drug Ineffective (2)Upper Limb Fracture (2)Aphasia (2)Gastritis (2)Death (2)

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

Possible Macugen side effects in male

Reported by a physician from Japan on 2012-08-09

Patient: male

Reactions: Cerebral Infarction

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Levofloxacin



Possible Macugen side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-27

Patient: female, weighing 73.5 kg (161.8 pounds)

Reactions: Glaucoma, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Micardis; Nerisona; Coniel; Xalcom; Novorapid; Kalimate; Hirudoid / 00723701 /; Azopt; Crestor; Famotidine



Possible Macugen side effects in male

Reported by a physician from Japan on 2012-07-19

Patient: male

Reactions: Cerebral Infarction

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Levofloxacin



Possible Macugen side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: female, weighing 74.8 kg (164.7 pounds)

Reactions: Off Label Use, Renal Transplant, Aphasia, Blindness Unilateral, Cerebrovascular Accident, Type 1 Diabetes Mellitus, Hypertension

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Macugen
    Dosage: (df intraocular) ; (df intraocular) ; (df intraocular)
    Indication: Diabetic Retinal Oedema
    Start date: 2008-09-05
    End date: 2008-09-05

Macugen
    Dosage: (df intraocular) ; (df intraocular) ; (df intraocular)
    Indication: Diabetic Retinal Oedema
    Start date: 2009-06-22
    End date: 2009-06-22

Macugen
    Dosage: (df intraocular) ; (df intraocular) ; (df intraocular)
    Indication: Diabetic Retinal Oedema
    Start date: 2009-03-30
    End date: 2009-03-30

Other drugs received by patient: Insulin



Possible Macugen side effects in

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

Patient:

Reactions: Off Label Use, Aphasia, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen
    Dosage: df, df, df
    Indication: Diabetic Retinal Oedema
    Start date: 2009-06-22
    End date: 2009-06-22

Macugen
    Dosage: df, df, df
    Indication: Diabetic Retinal Oedema
    Start date: 2008-09-05
    End date: 2008-09-05

Macugen
    Dosage: df, df, df
    Indication: Diabetic Retinal Oedema
    Start date: 2009-03-30
    End date: 2009-03-30



Possible Macugen side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-22

Patient: 73 year old female

Reactions: Procedural Pain, Eye Pain

Drug(s) suspected as cause:
Macugen



Possible Macugen side effects in 60 year old female

Reported by a physician from Japan on 2012-03-26

Patient: 60 year old female, weighing 73.5 kg (161.7 pounds)

Reactions: Dyslipidaemia, Glaucoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Sodium Polystyrene Sulfonate; Coniel (Benidipine Hydrochloride); Novolog; Xalacom (Latanoprost, Timolol Maleate); Hirudoid (Heparinoid); Micardis; Crestor; Azopt; Nerisone; Famotidine



Possible Macugen side effects in 60 year old female

Reported by a physician from Japan on 2012-03-21

Patient: 60 year old female, weighing 73.5 kg (161.7 pounds)

Reactions: Glaucoma, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Famotidine; Nerisone; Xalacom (Latanoprost, Timolol Maleate); Azopt; Hirudoid (Heparinoid); Novolog; Coniel (Benidipine Hydrochloride); Crestor; Sodium Polystyrene Sulfonate; Micardis



Possible Macugen side effects in 76 year old female

Reported by a physician from Italy on 2012-03-21

Patient: 76 year old female

Reactions: Upper Limb Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Combisartan (Hydrochlorothiazide, Valsartan); Simvastatin; Aspirin; Methylprednisolone; Pantoprazole



Possible Macugen side effects in 67 year old male

Reported by a physician from Germany on 2012-03-19

Patient: 67 year old male

Reactions: Epididymitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Roekan (Ginkgo Biloba Extract); Gabapentin; Opipramol Hydrochloride (Opipramol Hydrochloride)



Possible Macugen side effects in 72 year old male

Reported by a physician from Japan on 2012-03-19

Patient: 72 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Intraocular Pressure Increased, Gastritis

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Rinderon A (Betamethasone Sodium Phosphate, Neomycin Sulfate); Mucosta (Rebamipide); Methycobal (Mecobalamin); Bronuck (Bromfenac Sodium); Aspara K (Aspartate Potassium); Lomefloxacin Hydrochloride (Lomefloxacin Hydrochloride); Carnaculin (Pancreas Extract); Xalatan; Juvela (Tocopherol); Adona (Carbazochrome Sodium Sulfonate); Mikelan (Carteolol Hydrochloride); Hyalonsan (Hyaluronic Acid); Trusopt; Diamox



Possible Macugen side effects in 85 year old female

Reported by a physician from Slovakia (Slovak Republic) on 2012-03-19

Patient: 85 year old female

Reactions: Confusional State, Subdural Haematoma, Head Injury, RED Blood Cell Count Decreased, Fall, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Tarka; Fraxiparin (Heparin-Fraction, Calcium Salt); ALL Other Therapeutic Products; Betaserc (Betahistine Hydrochloride); ALL Other Therapeutic Products; Cavinton (Vinpocetine); Metformin Hydrochloride; Calcium Carbonate



Possible Macugen side effects in 78 year old male

Reported by a physician from Japan on 2012-03-19

Patient: 78 year old male

Reactions: Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Tazin (Carbazochrome Sodium Sulfonate); Carnaculin (Pancreas Extract); Lomefloxacin Hydrochloride (Lomefloxacin Hydrochloride); Pranoprofen (Pranoprofen); Betamethasone



Possible Macugen side effects in 81 year old female

Reported by a physician from Japan on 2012-03-14

Patient: 81 year old female, weighing 41.0 kg (90.2 pounds)

Reactions: Retinal Haemorrhage

Drug(s) suspected as cause:
Macugen
    Dosage: 0.3mg, single, intraocular
    Indication: Choroidal Neovascularisation
    Start date: 2010-12-22

Macugen
    Dosage: 0.3mg, single, intraocular
    Indication: AGE-Related Macular Degeneration
    Start date: 2010-12-22

Other drugs received by patient: Adona (Carbazochrome Sodium Sulfonate); Kary UNI (Pirenoxine); Levofloxacin



Possible Macugen side effects in male

Reported by a physician from Spain on 2012-03-05

Patient: male

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Macugen



Possible Macugen side effects in 76 year old female

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

Patient: 76 year old female

Reactions: Upper Limb Fracture, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Combisartan (Hydrochlorothiazide, Valsartan); Aspirin; Simvastatin; Methylprednisolone; Pantoprazole



Possible Macugen side effects in male

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

Patient: male

Reactions: Cardiac Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Macugen



Possible Macugen side effects in 95 year old male

Reported by a consumer/non-health professional from India on 2012-02-15

Patient: 95 year old male

Reactions: Hypertension, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen



Possible Macugen side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-09

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Avastin
    Indication: AGE-Related Macular Degeneration
    Start date: 2005-11-05
    End date: 2006-05-02

Lucentis
    Indication: AGE-Related Macular Degeneration
    Start date: 2004-12-05
    End date: 2006-12-06

Macugen
    Indication: AGE-Related Macular Degeneration
    Start date: 2005-02-18
    End date: 2005-09-27

Other drugs received by patient: Glipizide; Avapro; Coumadin; Flomax; Preservision Lutein



Possible Macugen side effects in 86 year old male

Reported by a physician from France on 2012-01-23

Patient: 86 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Vitreous Fibrin

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Macugen



Possible Macugen side effects in 81 year old male

Reported by a physician from Japan on 2012-01-13

Patient: 81 year old male

Reactions: Retinal Haemorrhage, Visual Acuity Reduced

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen
    Dosage: 0.3 mg, intraocular
    Indication: AGE-Related Macular Degeneration
    Start date: 2010-01-28
    End date: 2010-01-28

Macugen
    Dosage: 0.3 mg, intraocular
    Indication: Choroidal Neovascularisation
    Start date: 2010-01-28
    End date: 2010-01-28

Other drugs received by patient: Levofloxacin; Flomox (Cefcapene Pivoxil Hydrochloride)



Possible Macugen side effects in 81 year old male

Reported by a physician from Japan on 2012-01-06

Patient: 81 year old male

Reactions: Retinal Haemorrhage, Visual Acuity Reduced

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen



Possible Macugen side effects in 74 year old male

Reported by a physician from Japan on 2012-01-05

Patient: 74 year old male

Reactions: Retinal Pigment Epithelial Tear, Visual Acuity Reduced

Drug(s) suspected as cause:
Macugen
    Dosage: 0.3 mg, intraocular
    Indication: Choroidal Neovascularisation
    Start date: 2008-12-24
    End date: 2008-12-24

Macugen
    Dosage: 0.3 mg, intraocular
    Indication: AGE-Related Macular Degeneration
    Start date: 2008-12-24
    End date: 2008-12-24

Other drugs received by patient: Moxifloxacin HCL; Moxifloxacin HCL; Xylcoaine (Lidocaine Hydrochloride); Isodine (Povidone-Iodine); Mydrin P (Phenylephrine Hydrochloride, Tropicamide)



Possible Macugen side effects in 72 year old male

Reported by a physician from Japan on 2011-12-27

Patient: 72 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Intraocular Pressure Increased, Gastritis

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Mucosta (Rebamipide); Juvela (Tocopherol); Adona (Carbazochrome Sodium Sulfonate); Mikelan (Cartelol Hydrochloride); Carnaculin (Pancreas Extract); Diamox; Aspara K (Aspartate Potassium); Methycobal (Mecobalamin); Trusopt; Rinderon A (Betamethasone Sodium Phosphate, Neomycin Sulfate); Lomefloxacin Hydrochloride (Lomefloxacin Hydrochloride); Hyalonsan (Hyaluronic Acid); Bronuck (Bromfenac Sodium); Xalatan



Possible Macugen side effects in female

Reported by a individual with unspecified qualification from United States on 2011-12-08

Patient: female

Reactions: Dysphagia, Drug Ineffective, Ocular Discomfort, Injection Site Discharge, Local Swelling, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Percocet; Glimepiride; Aspirin; Synthroid



Possible Macugen side effects in 82 year old male

Reported by a physician from Japan on 2011-11-28

Patient: 82 year old male

Reactions: Cerebral Infarction

Drug(s) suspected as cause:
Macugen
    Dosage: 0.3 mg into the left eye, intraocular
    Indication: Choroidal Neovascularisation
    Start date: 2010-05-25

Macugen
    Dosage: 0.3 mg into the left eye, intraocular
    Indication: AGE-Related Macular Degeneration
    Start date: 2010-05-25

Other drugs received by patient: Levofloxacin



Possible Macugen side effects in 90 year old male

Reported by a physician from Japan on 2011-11-16

Patient: 90 year old male, weighing 51.0 kg (112.2 pounds)

Reactions: Cerebral Infarction, Blood Pressure Systolic Increased

Adverse event resulted in: death

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Levofloxacin; Humalin (Insulin); Urief (Silodosin); Bromfenac Sodium (Bromfenac Sodium); Fulcaliq (Amino Acids Nos, Electrolytes Nos, Glucose, Vitamins Nos); Xylocaine



Possible Macugen side effects in 72 year old female

Reported by a physician from Japan on 2011-11-14

Patient: 72 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Intraocular Pressure Increased

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Methycobal (Mecobalamin); Bronuck (Bromfenac Sodium); Carnaculin (Pancreas Extract); Adona (Carbazochrome Sodium Sulfonate); Rinderon A (Betamethasone Sodium Phosphate, Neomycin Sulfate); Mikelan (Carteolol Hydrochloride); Lomefloxacin Hydrochloride (Lomefloxacin Hydrochloride); Xalatan; Mucosta (Rebamipide); Hyalonsan (Hyaluronic Acid); Diamox; Juvela (Tocopherol); Trusopt; Aspara K (Aspartate Potassium)



Possible Macugen side effects in female

Reported by a physician from Japan on 2011-11-14

Patient: female

Reactions: Palpitations, Drug Ineffective, Oedema, Injection Site Pain, Visual Acuity Reduced, Blindness

Drug(s) suspected as cause:
Macugen



Possible Macugen side effects in 80 year old male

Reported by a physician from Japan on 2011-11-03

Patient: 80 year old male, weighing 42.0 kg (92.4 pounds)

Reactions: Vitreous Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Macugen

Other drugs received by patient: Pansporin T (Cefotiam Hexetil Hydrochloride); Adona (Carbazochrome Sodium Sulfonate; Bestron (Cefmenoxime Hydrochloride); Gatifloxacin

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