Zoryve Side Effects Center

Last updated on RxList: 8/12/2022
Zoryve Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Zoryve?

Zoryve (roflumilast) Cream is a phosphodiesterase 4 inhibitor indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

What Are Side Effects of Zoryve?

Side effects of Zoryve include:

  • diarrhea,
  • headache,
  • insomnia,
  • application site pain,
  • upper respiratory tract infections, and
  • urinary tract infections (UTIs).

Zoryve may cause serious side effects including:

  • hives, 
  • difficulty breathing, 
  • swelling of your face, lips, tongue, or throat, 
  • dizziness, 
  • mood or behavior changes, 
  • anxiety, 
  • depression, 
  • trouble sleeping, 
  • impulsive thoughts, 
  • thoughts of self-harm, 
  • rapid and unintended weight loss, 
  • pain or burning when you urinate, and 
  • tremors

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Zoryve

The dose of Zoryve is a once daily application to affected areas.

Zoryve In Children

The safety and effectiveness of Zoryve have been established in pediatric patients ages 12 years and older for the treatment of plaque psoriasis.

The safety and effectiveness of Zoryve in pediatric patients below the age of 12 years have not been established.

What Drugs, Substances, or Supplements Interact with Zoryve?

Zoryve may interact with other medicines such as:

  • systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) and
  • oral contraceptives containing gestodene and ethinyl estradiol.

Tell your doctor all medications and supplements you use.

Zoryve During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Zoryve; it is unknown if it might affect a fetus. Zoryve should not be used during labor and delivery. It is unknown if Zoryve passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Zoryve (roflumilast) Cream, for Topical Use 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.

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.

SLIDESHOW

Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Zoryve Professional Information

SIDE EFFECTS

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 another drug and may not reflect the rates observed in practice.

In two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2), 881 subjects 2 years of age or older with plaque psoriasis were treated with ZORYVE or vehicle once daily for 8 weeks.

The median age was 47 years (range 6 to 88). The majority of the subjects were male (64%) and White (82%). The median body surface area (BSA) affected was 5.5% (range 2%to 20%).

The proportion of subjects who discontinued treatment due to adverse reaction was1.0% for subjects treated with ZORYVEand 1.3% for subjects treated with vehicle. The most common adverse reactions that led to discontinuation of ZORYVE was application site urticaria (0.3%).

Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE, and for which the rate exceeded the rate for vehicle.

Table 1: Adverse Reactions Reported in ≥1% of Subjects Treated with ZORYVE for 8 Weeks

Adverse Reaction ZORYVE
(N=576) n (%)
Vehicle
(N=305) n (%)
Diarrhea 18 (3.1) 0 (0.0)
Headache 14 (2.4) 3 (1.0)
Insomnia 8 (1.4) 2 (0.7)
Nausea 7 (1.2) 1 (0.3)
Application site pain 6 (1.0) 1 (0.3)
Upper respiratory tract infection 6 (1.0) 1 (0.3)
Urinary tract infection 6 (1.0) 2 (0.7)

In 594 subjects who continued treatment with ZORYVE for up to 64 weeks in open-label extension trials, the adverse reaction profile was similar to that observed in vehicle-controlled trials.

DRUG INTERACTIONS

No formal drug-drug interaction studies were conducted with ZORYVE.

Drugs That Inhibit Cytochrome P450 (CYP) Enzymes

The coadministration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit [see CLINICAL PHARMACOLOGY].

Oral Contraceptives Containing Gestodene And Ethinyl Estradiol

The coadministration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects. The risk of such concurrent use should be weighed carefully against benefit [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Zoryve (Roflumilast Cream)

QUESTION

Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer

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

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