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Qutenza

Last reviewed on RxList: 2/22/2016
Qutenza Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/17/2016

Qutenza (capsaicin) 8% Patch is a manmade version of a naturally occurring compound found in chili peppers used to manage neuropathic pain associated with postherpetic neuralgia (nerve pain following an outbreak of shingles). Common side effects of Qutenza Patch include application site reactions (pain, redness, itching, swelling, burning, dryness, rash or bumps), increased blood pressure, runny or stuffy nose, sore throat, cough, nausea, or vomiting.

The recommended dose of Qutenza is a single, 60-minute application of up to four patches. Treatment may be repeated every three months or as warranted by the return of pain (not more frequently than every three months). Qutenza is only administered under the close supervision of a physician. Qutenza may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Qutenza. It is unknown if this drug passes into breast milk. Mothers can reduce infant exposure by not breastfeeding after treatment on the day of treatment. Consult your doctor before breastfeeding.

Our Qutenza (capsaicin) 8% Patch Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Qutenza Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Application-Associated Pain [see WARNINGS AND PRECAUTIONS]
  • Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in clinical practice.

Across all controlled and uncontrolled trials, more than 1,600 patients have received Qutenza. A total of 394 patients received more than one treatment application and 274 patients were followed for 48 weeks or longer.

In controlled clinical studies, 98% of patients completed ≥ 90% of the intended patch application duration. Among patients treated with Qutenza, 1% discontinued prematurely due to an adverse event.

Controlled Clinical Studies

Common Adverse Reactions

Adverse reactions occurring in ≥ 5% of patients in the Qutenza group and at an incidence greater than in the control group were application site erythema, application site pain, application site pruritus and application site papules.

Table 1 summarizes all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with postherpetic neuralgia in the Qutenza group for which the incidence was greater than in the control group. The majority of application site reactions were transient and self-limited. Transient increases in pain were commonly observed on the day of treatment in patients treated with Qutenza. Pain increases occurring during patch application usually began to resolve after patch removal. On average, pain scores returned to baseline by the end of the treatment day and then remained at or below baseline levels. A majority of Qutenza-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.

TABLE 1: Treatment-emergent adverse reaction incidence (%) in controlled trials in Postherpetic Neuralgia (Events in ≥ 1% of Qutenza-treated patients and at least 1% greater in the Qutenza group than in the Control group)

Body System Preferred Term Qutenza 60 minutes
(N = 622) %
Control 60 minutes
(N = 495) %
General Disorders and Administration Site Conditions
Application Site Erythema 63 54
Application Site Pain 42 21
Application Site Pruritus 6 4
Application Site Papules 6 3
Application Site Edema 4 1
Application Site Swelling 2 1
Application Site Dryness 2 1
Infections and Infestations
Nasopharyngitis 4 2
Bronchitis 2 1
Sinusitis 3 1
Gastrointestinal Disorders
Nausea 5 2
Vomiting 3 1
Skin and Subcutaneous Tissue Disorder
Pruritus 2 < 1
Vascular Disorders
Hypertension 2 1

Other Adverse Reactions Observed During the Clinical Studies of Qutenza

General Disorders and Administration Site Conditions: Application site urticaria, Application site paresthesia, Application site dermatitis, Application site hyperesthesia, Application site excoriation, Application site warmth, Application site anesthesia, Application site bruising, Application site inflammation, Application site exfoliation, Peripheral edema

Nervous System Disorders: Headache, Burning sensation, Peripheral sensory neuropathy, Dizziness, Dysgeusia, Hyperesthesia, Hypoesthesia

Respiratory, Thoracic and Mediastinal Disorders: Cough, Throat irritation

Skin and Subcutaneous Tissue Disorders: Abnormal skin odor

Read the entire FDA prescribing information for Qutenza (Capsaicin 8% Patch)

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Related Resources for Qutenza

© Qutenza Patient Information is supplied by Cerner Multum, Inc. and Qutenza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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