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Qutenza (Capsaicin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Qutenza (Capsaicin) 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 (65)
Death (5)
Life Threatening Events (5)
Disability (1)

Reports by Reaction Type

Application Site Pain (26)Application Site Erythema (15)Condition Aggravated (8)Hypertension (7)Neuralgia (7)Pain (6)Application Site Swelling (5)Application Site Pruritus (5)Dizziness (5)Application Site Vesicles (5)Hypersensitivity (4)Drug Ineffective (4)

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

Possible Qutenza side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-02

Patient: 62 year old female

Reactions: Vomiting, Hypothermia, Nausea, Hypotension, Loss of Consciousness, Malaise, Syncope, Presyncope, Allodynia, Neuralgia

Drug(s) suspected as cause:
Qutenza
    Dosage: (df [patch, applied to the knee] topical)
    Administration route: Topical
    Indication: Allodynia
    Start date: 2012-07-12
    End date: 2012-07-12

Qutenza
    Dosage: (df [patch, applied to the knee] topical)
    Administration route: Topical
    Indication: Neuralgia
    Start date: 2012-07-12
    End date: 2012-07-12

Other drugs received by patient: Acetaminophen and Tramadol HCL



Possible Qutenza side effects in 75 year old

Reported by a health professional (non-physician/pharmacist) from Greece on 2012-08-02

Patient: 75 year old

Reactions: Angina Unstable

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza



Possible Qutenza side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-20

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Application Site Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Targin; Lyrica; Amitriptyline HCL



Possible Qutenza side effects in 64 year old male

Reported by a health professional (non-physician/pharmacist) from Norway on 2012-07-13

Patient: 64 year old male, weighing 85.0 kg (187.0 pounds)

Reactions: Post Herpetic Neuralgia, Condition Aggravated, Product Used FOR Unknown Indication

Drug(s) suspected as cause:
Morphine
    Dosage: (df [only occassionally]), (df [40 mg x 1])
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Morphine
    Dosage: (df [only occassionally]), (df [40 mg x 1])
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-04

Qutenza
    Dosage: topical
    Administration route: Topical
    Indication: Post Herpetic Neuralgia
    Start date: 2012-05-04
    End date: 2012-05-04



Possible Qutenza side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-10

Patient: male

Reactions: Chills, Anaphylactic Shock, Application Site Erythema, Rash

Drug(s) suspected as cause:
Qutenza
    Dosage: (1 df, [patch] topical)
    Administration route: Topical
    Indication: Scar

Qutenza
    Dosage: (1 df, [patch] topical)
    Administration route: Topical
    Indication: Neuralgia



Possible Qutenza side effects in female

Reported by a physician from France on 2012-06-19

Patient: female

Reactions: Application Site Pain, Hypertension

Drug(s) suspected as cause:
Qutenza
    Dosage: 4 df (patch) (topical)
    Administration route: Topical
    Indication: Back Pain
    Start date: 2012-06-01

Qutenza
    Dosage: 4 df (patch) (topical)
    Administration route: Topical
    Indication: Sciatica
    Start date: 2012-06-01



Possible Qutenza side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-15

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Ruptured Cerebral Aneurysm, Subarachnoid Haemorrhage, Circulatory Collapse, Cerebrovascular Disorder, Headache, Cerebral Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Emla; Amitriptyline HCL; Palexia; Naratriptan



Possible Qutenza side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-14

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Off Label Use, Drug Ineffective, Hypertension

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Lidocaine



Possible Qutenza side effects in male

Reported by a physician from Czech Republic on 2012-06-05

Patient: male

Reactions: Cerumen Impaction, Deafness Transitory

Drug(s) suspected as cause:
Qutenza



Possible Qutenza side effects in male

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

Patient: male

Reactions: Upper Respiratory Tract Infection, RED Blood Cells Urine Positive, Enterovirus Test Positive, Blood Albumin Decreased, CD4 / CD8 Ratio Decreased, White Blood Cells Urine Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Folic Acid; Qdcal; Gabapentin; Multi-Vitamins; Oxynorm; Omeprazole; Nevirapine; Tramadol HCL; Zopiclone; Clonazepam; Truvada



Possible Qutenza side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: female, weighing 67.6 kg (148.7 pounds)

Reactions: Feeling Hot, Pain, Post Herpetic Neuralgia, Condition Aggravated, Application Site Vesicles

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Topamax; Hydrocodone (Unknown); Cymbalta; Neurontin (Unknown)



Possible Qutenza side effects in female

Reported by a physician from Czech Republic on 2012-05-17

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Osteoarthritis, Hyperkalaemia, Urinary Tract Infection, Chest Pain, Condition Aggravated, Renal Cyst, Hypertension, Hepatic Steatosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Humulin R; Indap; Amprilan; Nitrofurantoin; Vasocardin; Kalnormin; Aspirin; Lantus; Pricoron



Possible Qutenza side effects in female

Reported by a physician from Czech Republic on 2012-05-17

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Phlebolith, Urinary Tract Infection, Condition Aggravated, Foreign Body, Renal Cyst, Hepatic Steatosis, Hypokalaemia, Osteoarthritis, Blood Calcium Decreased, Chest Pain, Hypertension, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Nitrofurantoin; Humulin R; Pricoron; Lantus; Aspirin; Indap; Kalnormin; Amprilan; Vasocardin



Possible Qutenza side effects in female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-05-17

Patient: female

Reactions: Movement Disorder, Application Site Swelling, Application Site Erythema, Application Site Pain

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Pregabalin; Tilidine



Possible Qutenza side effects in female

Reported by a physician from Germany on 2012-05-16

Patient: female, weighing 110.0 kg (242.0 pounds)

Reactions: Refusal of Treatment by Patient, Complex Regional Pain Syndrome, Application Site Swelling, Skin Burning Sensation, Application Site Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Analgescis



Possible Qutenza side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-15

Patient: male

Reactions: Upper Respiratory Tract Infection, RED Blood Cells Urine Positive, White Blood Cells Urine Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Qdcal; Zopiclone; Multi-Vitamins; Folic Acid; Tramadol Hydrochloride; Gabapentin; Omeprazole; Truvada; Oxynorm; Clonazepam; Nevirapine



Possible Qutenza side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-10

Patient: female

Reactions: Complex Regional Pain Syndrome, Disease Recurrence

Drug(s) suspected as cause:
Qutenza



Possible Qutenza side effects in female

Reported by a physician from Czech Republic on 2012-05-08

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Chest Pain, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza
    Dosage: (df [bimonthly application] topical)
    Administration route: Topical
    Indication: Polyneuropathy
    Start date: 2012-02-09
    End date: 2012-02-09

Study Drug
    Dosage: (df)
    Indication: Polyneuropathy

Other drugs received by patient: Anopyrin; Humulin R; Lantus; Amprilan



Possible Qutenza side effects in female

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

Patient: female, weighing 71.0 kg (156.2 pounds)

Reactions: Drug Tolerance Decreased, NO Therapeutic Response, Oedema Peripheral, Application Site Pain, Temperature Intolerance, Application Site Vesicles

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Clonidine; Lidocaine; Lidocain / 00033401 /; Metamizol / 06276704 /; Novamin / 06276704 /; Local Cooling



Possible Qutenza side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-03

Patient: 31 year old female

Reactions: Neuropathy Peripheral, Activities of Daily Living Impaired, Chest Pain, Condition Aggravated, Application Site Pain, Application Site Hyperaesthesia, Application Site Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza
    Dosage: (1.5 df, [applied to th 2-4 right] topical)
    Administration route: Topical
    Indication: Neuropathy Peripheral
    Start date: 2012-04-18
    End date: 2012-04-18

Qutenza
    Dosage: (1.5 df, [applied to th 2-4 right] topical)
    Administration route: Topical
    Indication: Chest Pain
    Start date: 2012-04-18
    End date: 2012-04-18

Qutenza
    Dosage: (1.5 df, [applied to th 2-4 right] topical)
    Administration route: Topical
    Indication: Procedural Pain
    Start date: 2012-04-18
    End date: 2012-04-18

Other drugs received by patient: Amitriptyline HCL; Palladone; Gabapentin; Lidocain / 00033401 /



Possible Qutenza side effects in

Reported by a physician from Czech Republic on 2012-05-02

Patient:

Reactions: Deafness

Drug(s) suspected as cause:
Qutenza



Possible Qutenza side effects in female

Reported by a physician from Belgium on 2012-04-27

Patient: female, weighing 83.0 kg (182.6 pounds)

Reactions: Off Label Use

Drug(s) suspected as cause:
Study Drug
    Dosage: (df)
    Indication: Neuropathy Peripheral
    Start date: 2012-02-02
    End date: 2012-02-02

Qutenza
    Dosage: (1 df 1x, [patch, applied to foot] topical)
    Administration route: Topical
    Indication: Neuropathy Peripheral
    Start date: 2012-02-02
    End date: 2012-02-02

Other drugs received by patient: Escitalopram Oxalate; Gabapentin; Depakene; Nortriptyline HCL



Possible Qutenza side effects in female

Reported by a consumer/non-health professional from Germany on 2012-04-25

Patient: female

Reactions: Complex Regional Pain Syndrome, Application Site Swelling, Skin Burning Sensation, Application Site Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Analgesics



Possible Qutenza side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-23

Patient: female

Reactions: Gastroenteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: B12-Vitamin; Lansoprazole; Metformin HCL; Risedronate Sodium; Prednisolone; Simvastatin



Possible Qutenza side effects in female

Reported by a physician from France on 2012-04-19

Patient: female

Reactions: Burns Second Degree, Application Site Papules, Application Site Burn, Application Site Pain, Application Site Vesicles, Erythema, Application Site Pruritus

Drug(s) suspected as cause:
Qutenza
    Dosage: (1.5 df, [patch, applied on her wrist] topical)
    Administration route: Topical
    Indication: Neuralgia
    Start date: 2012-02-16
    End date: 2012-02-16

Qutenza
    Dosage: (1.5 df, [patch, applied on her wrist] topical)
    Administration route: Topical
    Indication: Allodynia
    Start date: 2012-02-16
    End date: 2012-02-16

Other drugs received by patient: Oxycontin; Effexor; Prazepam; Temazepam; Ebastine; Zolpidem Tartrate



Possible Qutenza side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-17

Patient: female

Reactions: Gastroenteritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Risedronate Sodium; Lansoprazole; Prednisolone; Metformin HCL; B12-Vitamin; Simvastatin



Possible Qutenza side effects in male

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

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: death

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Lidocaine; Lyrica



Possible Qutenza side effects in 55 year old male

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

Patient: 55 year old male

Reactions: Application Site Pain, Allodynia

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Cymbalta; Lyrica; Norspan / 00444001 /; Neurocil / 00038602 /



Possible Qutenza side effects in male

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

Patient: male

Reactions: Guillain-Barre Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Qutenza
    Dosage: (2 df, [patch, on the feet] topical)
    Administration route: Topical
    Indication: Polyneuropathy
    Start date: 2011-08-01
    End date: 2011-08-01

Qutenza
    Dosage: (2 df, [patch, on the feet] topical)
    Administration route: Topical
    Indication: Pain
    Start date: 2011-08-01
    End date: 2011-08-01

Other drugs received by patient: Omeprazol / 00661203 /; Truvada; Dipiperon; Kaletra; Lyrica; Lidocaine; Ibuprofen



Possible Qutenza side effects in female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-04-03

Patient: female

Reactions: Movement Disorder, Application Site Swelling, Application Site Pain, Application Site Erythema

Drug(s) suspected as cause:
Qutenza

Other drugs received by patient: Pregabalin; Tilidine

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