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Solaraze (Diclofenac Topical) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Solaraze (Diclofenac Topical) 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 (10)

Reports by Reaction Type

Headache (2)Erythema (2)Hallucination (2)Glaucoma (1)Seborrhoeic Dermatitis (1)Tachycardia (1)Application Site Exfoliation (1)Basal Cell Carcinoma (1)Application Site Erythema (1)Swelling Face (1)Application Site Atrophy (1)Arrhythmia (1)

Possible Solaraze side effects in 70 year old male

Reported by a consumer/non-health professional from Spain on 2012-08-06

Patient: 70 year old male

Reactions: Cardiac Pacemaker Insertion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Solaraze



Possible Solaraze side effects in male

Reported by a consumer/non-health professional from Spain on 2012-07-11

Patient: male

Reactions: Tachycardia, Hypertension, Arrhythmia

Drug(s) suspected as cause:
Solaraze

Other drugs received by patient: Diltiazem Hydrocholoride; Digoxin; Atorvastatin; Valsartan / Hydrochlorothiazide; Acenocumarol; Metformin HCL



Possible Solaraze side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-04

Patient: 63 year old male

Reactions: Erythema, Pemphigoid

Drug(s) suspected as cause:
Solaraze
    Administration route: Topical

Solaraze
    Administration route: Topical
    Indication: Actinic Keratosis



Possible Solaraze side effects in 95 year old male

Reported by a consumer/non-health professional from Germany on 2012-05-22

Patient: 95 year old male, weighing 69.8 kg (153.7 pounds)

Reactions: Headache, Hallucination

Drug(s) suspected as cause:
Solaraze
    Administration route: Topical
    Start date: 2011-12-09
    End date: 2011-12-15

Solaraze
    Administration route: Topical
    Indication: Actinic Keratosis
    Start date: 2011-12-01
    End date: 2011-12-08

Other drugs received by patient: Ramipril; Aspirin; Simvastatin; Pantoprazole; Allopurinol; Diclofenac Sodium; Euthyrox



Possible Solaraze side effects in 72 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-16

Patient: 72 year old male

Reactions: Glaucoma, Ocular Hypertension

Drug(s) suspected as cause:
Solaraze



Possible Solaraze side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-05-04

Patient: 64 year old male

Reactions: Seborrhoeic Dermatitis

Drug(s) suspected as cause:
Solaraze



Possible Solaraze side effects in 68 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-24

Patient: 68 year old male

Reactions: Swelling Face, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Solaraze
    Dosage: ;bid;top;bid;top
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-22
    End date: 2012-03-23

Solaraze
    Dosage: ;bid;top;bid;top
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-01-01



Possible Solaraze side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-04-24

Patient: 64 year old male

Reactions: Application Site Exfoliation, Application Site Erythema

Drug(s) suspected as cause:
Solaraze



Possible Solaraze side effects in 90 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-13

Patient: 90 year old male

Reactions: Headache, Hallucination

Drug(s) suspected as cause:
Solaraze



Possible Solaraze side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-11

Patient: male

Reactions: Application Site Atrophy, Basal Cell Carcinoma

Drug(s) suspected as cause:
Solaraze

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