Qutenza

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 3/8/2022
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.

QUESTION

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Qutenza Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash the skin and get medical attention right away if you have severe burning, pain, swelling, or blistering of the skin where you applied this medicine.

Stop using capsaicin topical and call your doctor at once if you have:

  • severe pain or skin redness where the medicine was applied;
  • loss of feeling;
  • trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

Common side effects may include pain or a burning sensation that can last for several hours or days (especially after your first use of capsaicin topical).

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.

Read the entire detailed patient monograph for Qutenza (Capsaicin 8% Patch)

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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 [see WARNINGS AND PRECAUTIONS]
  • Application-Associated Pain [see WARNINGS AND PRECAUTIONS]
  • Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Sensory Function Reduction [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 clinical trials, 2848 patients have received QUTENZA. A total of 924 patients received more than one treatment application and 732 patients were followed for 48 weeks or longer. A total of 590 DPN patients and 1112 PHN patients have received QUTENZA across all controlled and uncontrolled clinical trials.

Among patients treated with QUTENZA, 1% discontinued prematurely due to an adverse event.

Most Common Adverse Reactions In All Controlled Clinical Trials

In all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the QUTENZA group and at an incidence at least 1% greater than in the control group were application site erythema, application site pain, and application site pruritus.

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 trials had adverse reactions with a maximum intensity of “mild” or “moderate”.

Postherpetic Neuralgia (PHN)

Table 1 summarizes all adverse reactions, regardless of causality, occurring in >1% of patients with PHN in the QUTENZA group for which the incidence was at least 1% greater than in the control group.

TABLE 1: Adverse Reaction Incidence (%) in Controlled Double-blind 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

Less common adverse reactions (<1%) with QUTENZA observed during PHN clinical trials included: palpitations, tachycardia, eye pruritus, application site reactions (such as urticaria, paresthesia, dermatitis, hyperesthesia).

Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)

Table 2 summarizes all adverse reactions, regardless of causality, occurring in >1% of patients with DPN in the QUTENZA group for which the incidence was at least 1% greater than in the control group.

TABLE 2: Adverse Reaction Incidence (%) in Double-blind Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (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 30 minutes
(N=186) %
Control 30 minutes
(N=183) %
General Disorders and Administration Site Conditions
Application site reactions
Burning sensation 14 3
Application site pain 10 2
Erythema 2 0
Injury, Poisoning and Procedural Complications
Excoriation 2 0
Musculoskeletal and Connective Tissue Disorders
Pain in extremity 11 6
Nervous System Disorders
Headache 3 2
Respiratory, Thoracic and Mediastinal Disorders
Upper respiratory symptoms
Upper respiratory tract infection 4 < 1
Cough 2 < 1
Vascular Disorders
Hypertension 2 < 1

Less common adverse reactions (<1%) with QUTENZA observed during DPN clinical trials included: dizziness, dysesthesia, blister.

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).

DRUG INTERACTIONS

No clinical drug interaction studies have been performed.

Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed those measured in blood samples. Therefore, interactions with systemic medicinal products are unlikely.

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

© 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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