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Flector (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 Flector (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 (654)
Death (1)
Life Threatening Events (4)
Disability (1)

Reports by Reaction Type

Drug Ineffective (201)Pain (53)Dizziness (43)Nausea (39)Rash (32)Pruritus (29)Headache (25)Abdominal Discomfort (23)Malaise (23)Application Site Pain (17)Diarrhoea (17)Dyspnoea (16)

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

Possible Flector side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: False Positive Investigation Result

Drug(s) suspected as cause:
Flector



Possible Flector side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Rash Erythematous, Rash

Drug(s) suspected as cause:
Flector



Possible Flector side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Nuchal Rigidity

Drug(s) suspected as cause:
Flector



Possible Flector side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Gastrointestinal Haemorrhage

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 63 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Abdominal Discomfort, Abdominal Pain Upper

Drug(s) suspected as cause:
Flector
    Dosage: unk, 2x/day (1 patch every 12 hours)
    Indication: Fractured Coccyx
    Start date: 2012-08-13

Tylenol
    Dosage: unk
    Administration route: Oral



Possible Flector side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Drug Ineffective, Pain, Muscular Weakness

Drug(s) suspected as cause:
Flector



Possible Flector side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Cardiac Failure Congestive

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 65 year old male

Reported by a pharmacist from United States on 2012-08-23

Patient: 65 year old male

Reactions: Drug Ineffective, Product Adhesion Issue

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 71 year old female, weighing 53.1 kg (116.7 pounds)

Reactions: Asthma, Dyspnoea, Application Site Erythema, Throat Tightness, Cold Sweat, Influenza Like Illness

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Synthroid



Possible Flector side effects in 46 year old female

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

Patient: 46 year old female, weighing 75.7 kg (166.6 pounds)

Reactions: Drug Ineffective, Pain, Skin Erosion

Drug(s) suspected as cause:
Cortisone Acetate
    Dosage: unk

Flector
    Dosage: unk, 2x/day
    Indication: Bursitis
    Start date: 2012-07-27
    End date: 2012-01-01



Possible Flector side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Migraine, Application Site Irritation

Drug(s) suspected as cause:
Flector



Possible Flector side effects in female

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

Patient: female

Reactions: Abdominal Discomfort

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 87 year old female

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

Patient: 87 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Flector



Possible Flector side effects in male

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

Patient: male

Reactions: Application Site Reaction, Skin Haemorrhage, Ulcer

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 79 year old female

Reported by a physician from United States on 2012-08-21

Patient: 79 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Drug Ineffective, Haemorrhage Subcutaneous

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Methotrexate



Possible Flector side effects in 77 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 77 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Product Adhesion Issue, Feeling Abnormal

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Metformin



Possible Flector side effects in 78 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 78 year old female, weighing 76.6 kg (168.5 pounds)

Reactions: Dysstasia, Diverticulitis, Pain, Clostridial Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Spironolactone; Lasix; Plavix; Potassium; Zocor



Possible Flector side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 61 year old female, weighing 77.0 kg (169.4 pounds)

Reactions: Burning Sensation

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Cymbalta



Possible Flector side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 67 year old male

Reported by a pharmacist from United States on 2012-08-16

Patient: 67 year old male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 58 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Rash Pruritic

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Oxycodone



Possible Flector side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 73 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Application Site Bleeding

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Lipitor; Ibuprofen; Preservision EYE Vitamin



Possible Flector side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 73 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Application Site Bleeding

Drug(s) suspected as cause:
Flector
    Dosage: unk, daily
    Start date: 2012-08-09

Flector
    Dosage: unk, daily
    Indication: Arthritis
    Start date: 2012-03-14
    End date: 2012-08-06

Other drugs received by patient: Preservision EYE Vitamin; Lipitor; Ibuprofen



Possible Flector side effects in 22 year old male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 22 year old male, weighing 93.0 kg (204.5 pounds)

Reactions: Rash, Product Adhesion Issue, Blister

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 66 year old female, weighing 92.1 kg (202.5 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 67 year old female

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

Patient: 67 year old female, weighing 64.9 kg (142.7 pounds)

Reactions: Contusion

Drug(s) suspected as cause:
Flector
    Dosage: unk, 1x/day
    Administration route: Topical
    Indication: Meniscus Lesion
    Start date: 2012-08-03
    End date: 2012-08-04

Flector
    Indication: Back Disorder

Other drugs received by patient: Synthroid; Cozaar; Toprol-XL



Possible Flector side effects in 71 year old female

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

Patient: 71 year old female, weighing 53.1 kg (116.7 pounds)

Reactions: Asthma, Dyspnoea, Chills, Pyrexia, Application Site Erythema, Cold Sweat, Throat Tightness

Drug(s) suspected as cause:
Flector

Other drugs received by patient: Synthroid



Possible Flector side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Dermatitis Contact, Pruritus, Skin Exfoliation, Skin Burning Sensation, Erythema, Skin Irritation

Drug(s) suspected as cause:
Flector
    Dosage: unk, 1x/day
    Start date: 2012-01-01
    End date: 2012-08-03

Flector
    Dosage: unk, 1x/day
    Indication: Nerve Compression
    Start date: 2012-07-05
    End date: 2012-01-01



Possible Flector side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Drug Ineffective, Product Adhesion Issue

Drug(s) suspected as cause:
Flector



Possible Flector side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-09

Patient: 73 year old male

Reactions: Gastrointestinal Haemorrhage, Haemorrhagic Anaemia, Melaena, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 100 mg daily
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2011-04-16
    End date: 2012-05-11

Aspirin
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Start date: 2012-05-21

Escitalopram
    Dosage: 10 mg daily
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-04-01

Flector
    Dosage: unk
    Administration route: Topical
    End date: 2012-05-01

Glucophage
    Dosage: 850 mg daily
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    End date: 2012-05-01

Plavix
    Dosage: 75 mg, daily
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2011-04-26
    End date: 2012-05-11

Remeron
    Dosage: 30 mg daily
    Administration route: Oral
    Indication: Depression
    Start date: 2012-04-01

Other drugs received by patient: Tamsulosin HCL; Atorvastatin Calcium; Seroquel; Triatec Comp; Bisoprolol Fumarate; Lantus; Haldol

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