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adverse reactions ADVERSE REACTIONS Clinical Trial Experience: In 2 multicenter vehicle-controlled clinical trials of once-daily application of CUTIVATE ® Lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%. Events were local cutaneous events, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and inclusively were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection. The incidence of drug-related events on drug compared to vehicle (4% and 5%, respectively) was similar. The incidence of drug-related events between study populations of 242 pediatric patients (age 3 months to < 17 years) and 196 adult patients (17 years or older) (4% and 5%, respectively) was also similar. In an open-label study of 44 pediatric patients applying CUTIVATE ® Lotion to at least 35% of body surface area twice daily for 3 or 4 weeks, the overall incidence of drug-related adverse events was 14%. Events were local, cutaneous, and inclusively were dry skin (7%), stinging at application site (5%), and excoriation (2%). Table 2: Drug Related Adverse Events from Controlled Clinical Trials (n=438) Adverse Events CUTIVATE® Lotion Vehicle N=221 N=217 Burning/Stinging skin 4 (2%) 3 (1%) Contact Dermatitis 0 1 (<1%) Exacerbation of Atopic dermatitis 0 1 (<1%) Folliculitis of legs 2 (<1%) 0 Irritant Contact Dermatitis 0 1 (<1%) Pruritus 1 (<1%) 1 (<1%) Pustules on Arms 1 (<1%) 0 Rash 1 (<1%) 2 (<1%) Skin Infection 0 3 (1%) Table 3: Drug Related Adverse Events From Pediatric Open Label Trial (n=44) Adverse Events CUTIVATE ® Lotion Twice Daily Dry skin at multiple sites 3 (7%) Stinging at Application Sites 2 (5%) Excoriation 1 (2%) The table below summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in controlled clinical trials. Table 4: Adverse Events Occurring in ≥ 1% of Patients from Either Arm from Controlled Clinical Trials (n=438) Body System CUTIVATE ® Lotion Vehicle Lotion N = 221 N = 217 Any Adverse Event 77 (35%) 82 (38%) Skin Burning and Stinging 4 (2%) 3 (1%) Pruritus 3 (1%) 5 (2%) Rash 2 (<1%) 3 (1%) Skin Infection 0 3 (1%) Ear, Nose, Throat Common Cold 9 (4%) 5 (2%) Ear Infection 3 (1%) 3 (1%) Nasal Sinus Infection 2 (<1%) 4 (2%) Rhinitis 1 (<1%) 3 (1%) Upper Respiratory Tract Infection 6 (3%) 7 (3%) Gastrointestinal Normal Tooth Eruption 2 (< 1%) 3 (1%) Diarrhea 3 (1%) 0 Vomiting 3 (1%) 2 (<1%) Lower Respiratory Cough 7 (3%) 6 (3%) Influenza 5 (2%) 0 Wheeze 0 3 (1%) Neurology Headache 4 (2%) 5 (2%) Non-Site Specific Fever 8 (4%) 8 (4%) Seasonal Allergy 2 (<1%) 3 (1%) During the clinical trials, eczema herpeticum occurred in a 33-year-old male patient treated with CUTIVATE ® Lotion. Additionally, a 4-month-old patient treated with CUTIVATE ® Lotion in the open-label trial had marked elevations of the hepatic enzymes AST and ALT. Post Marketing Experience: Systemic adverse events with CUTIVATE ® Cream and CUTIVATE ® Ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling). The following localized adverse reactions have been reported during post approval use of CUTIVATE® Lotion: erythema, edema/swelling, bleeding, and a reported lack of efficacy. Because these 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.
adverse reactions table <table ID="_Reft2" width="100%"> <caption>Table 2: Drug Related Adverse Events from Controlled Clinical Trials (n=438)</caption> <col width="36%"/> <col width="40%"/> <col width="24%"/> <tbody> <tr> <td styleCode="Rrule Lrule Toprule " valign="top"> <paragraph>Adverse Events</paragraph> </td> <td styleCode="Rrule Toprule " valign="bottom"> <paragraph> CUTIVATE® Lotion</paragraph> </td> <td align="center" styleCode="Rrule Toprule " valign="bottom"> <paragraph>Vehicle</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"/> <td styleCode="Rrule Botrule " valign="top"> <paragraph> N=221</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>N=217</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Burning/Stinging skin</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 4 (2%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Contact Dermatitis</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Exacerbation of Atopic dermatitis</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Folliculitis of legs</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 2 (<1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Irritant Contact Dermatitis</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Pruritus</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Pustules on Arms</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Rash</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 2 (<1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Skin Infection</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph> 0</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> </tbody> </table>
adverse reactions table <table ID="_Reft3" width="100%"> <caption>Table 3: Drug Related Adverse Events From Pediatric Open Label Trial (n=44)</caption> <col width="37%"/> <col width="63%"/> <tbody> <tr> <td styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph>Adverse Events</paragraph> </td> <td align="center" styleCode="Rrule Botrule Toprule " valign="top"> <paragraph>CUTIVATE<sup>®</sup> Lotion Twice Daily</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Dry skin at multiple sites</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph>3 (7%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Stinging at Application Sites</paragraph> </td> <td align="center" styleCode="Rrule " valign="top"> <paragraph>2 (5%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph>Excoriation</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 (2%)</paragraph> </td> </tr> </tbody> </table>
adverse reactions table <table ID="_Reft4" width="100%"> <caption>Table 4: Adverse Events Occurring in ≥ 1% of Patients from Either Arm from Controlled Clinical Trials (n=438)</caption> <col width="26%"/> <col width="30%"/> <col width="44%"/> <tbody> <tr> <td styleCode="Rrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Body System</content> </paragraph> </td> <td styleCode="Rrule Toprule " valign="bottom"> <paragraph> <content styleCode="bold">CUTIVATE</content> <sup>®</sup> <content styleCode="bold"> Lotion</content> </paragraph> </td> <td styleCode="Rrule Toprule " valign="bottom"> <paragraph> <content styleCode="bold">Vehicle Lotion</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"/> <td styleCode="Rrule " valign="top"> <paragraph> <content styleCode="bold">N = 221</content> </paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> <content styleCode="bold">N = 217</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Any Adverse Event</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 77 (35%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 82 (38%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Skin</paragraph> </td> <td styleCode="Rrule " valign="top"/> <td styleCode="Rrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Burning and Stinging</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 4 (2%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Pruritus</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 5 (2%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Rash</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 2 (<1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Skin Infection</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Ear, Nose, Throat</paragraph> </td> <td styleCode="Rrule " valign="top"/> <td styleCode="Rrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Common Cold</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 9 (4%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 5 (2%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Ear Infection</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Nasal Sinus Infection</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 2 (<1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 4 (2%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Rhinitis</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 1 (<1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Upper Respiratory Tract Infection</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 6 (3%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 7 (3%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Gastrointestinal</paragraph> </td> <td styleCode="Rrule " valign="top"/> <td styleCode="Rrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Normal Tooth Eruption</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 2 (< 1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Diarrhea</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Vomiting</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 2 (<1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Lower Respiratory</paragraph> </td> <td styleCode="Rrule " valign="top"/> <td styleCode="Rrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Cough</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 7 (3%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 6 (3%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Influenza</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 5 (2%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Wheeze</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 0</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Neurology</paragraph> </td> <td styleCode="Rrule " valign="top"/> <td styleCode="Rrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Headache</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 4 (2%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 5 (2%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph>Non-Site Specific</paragraph> </td> <td styleCode="Rrule " valign="top"/> <td styleCode="Rrule " valign="top"/> </tr> <tr> <td styleCode="Rrule Lrule " valign="top"> <paragraph> Fever</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 8 (4%)</paragraph> </td> <td styleCode="Rrule " valign="top"> <paragraph> 8 (4%)</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph> Seasonal Allergy</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph> 2 (<1%)</paragraph> </td> <td styleCode="Rrule Botrule " valign="top"> <paragraph> 3 (1%)</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.