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Qutenza

Last reviewed on RxList: 7/31/2020
Qutenza Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Qutenza?

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).

What Are Side Effects of Qutenza?

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.

Dosage for Qutenza

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.

What Drugs, Substances, or Supplements Interact with Qutenza?

Qutenza may interact with other drugs. Tell your doctor all medications and supplements you use.

Qutenza During Pregnancy and Breastfeeding

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>

Additional Information

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:

  • Severe Irritation Due to Accidental Exposure of Eyes, Skin, Respiratory Tract, and Mucous Membranes]
  • 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 QUTENZA 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 QUTENZA application usually began to resolve after QUTENZA 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 TermQUTENZA 60 minutes
(N = 622) %
Control 60 minutes
(N = 495) %
General Disorders and Administration Site Conditions
Application Site Erythema6354
Application Site Pain4221
Application Site Pruritus64
Application Site Papules63
Application Site Edema41
Application Site Swelling21
Application Site Dryness21
Infections and Infestations
Nasopharyngitis42
Bronchitis21
Sinusitis31
Gastrointestinal Disorders
Nausea52
Vomiting31
Skin and Subcutaneous Tissue Disorder
Pruritus2< 1
Vascular Disorders
Hypertension21

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, Application site vesicles, Application site irritation, 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

Eye disorders: Eye irritation, Eye pain

Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post approval use of QUTENZA: second degree burn and scarring; accidental exposure (including eye pain, cough, eye and throat irritation).

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

QUESTION

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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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