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: 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 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 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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