{"id":62,"date":"2026-04-08T09:25:38","date_gmt":"2026-04-08T09:25:38","guid":{"rendered":"https:\/\/www.merckconnect.com\/ohtuvayre\/?page_id=62"},"modified":"2026-08-21T22:17:37","modified_gmt":"2026-08-21T22:17:37","slug":"adverse-reactions","status":"publish","type":"page","link":"https:\/\/www.merckconnect.com\/ohtuvayre\/adverse-reactions\/","title":{"rendered":"Safety profile"},"content":{"rendered":"\n\n
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OHTUVAYRE\u00ae (ensifentrine) safety profile<\/h1>

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Adverse reactions in the ENHANCE trials1<\/sup><\/h2><\/div>\n\n\n\n
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<\/span><\/span>Discontinuation of OHTUVAYRE due to adverse reactions<\/strong>.

7.6% in the OHTUVAYRE group vs 8.2% on placebo

Adverse reactions reported in the 48-week cohort were consistent with those observed in the pooled 24-week safety population.
<\/span>ENHANCE, E<\/strong>nsifentrine as a N<\/strong>ovel inHA<\/strong>led N<\/strong>ebulized C<\/strong>OPD thE<\/strong>rapy.<\/span><\/p><\/blockquote><\/div>\n<\/div>\n\n\n\n

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Adverse reactions \u22651% and more common than placebo in patients with COPD in the pooled 24-week safety population (ENHANCE-1 and ENHANCE-2)<\/h4><\/div>\n\n\n\n
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Adverse reactions<\/mark><\/strong><\/td>OHTUVAYRE
N=975<\/mark><\/strong>
n (%)<\/strong><\/td>		Placebo
N=574<\/strong><\/mark>
n (%)<\/strong><\/td><\/tr>
Back pain<\/strong><\/td>18 (1.8%)<\/strong><\/td>6 (1.0%)<\/strong><\/td><\/tr>
Hypertension<\/span><\/strong><\/td>17 (1.7%)<\/strong><\/td>5 (0.9%)<\/strong><\/td><\/tr>
Urinary tract infection<\/strong><\/td>13 (1.3%)<\/strong><\/td>6 (1.0%)<\/strong><\/td><\/tr>
Diarrhea<\/strong><\/td>10 (1.0%)<\/strong><\/td>4 (0.7%)<\/strong><\/td><\/tr><\/tbody><\/table>
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Please see additional <\/strong>Warnings and Precautions<\/strong><\/a> within the Select Safety Information, including acute episodes of bronchospasm, paradoxical bronchospasm, and psychiatric events including suicidality.<\/strong><\/p>\n\n\n\n

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Actor Portrayal<\/div><\/div>
Actor Portrayal<\/div><\/div><\/picture>

Learn about<\/mark> the delivery system of OHTUVAYRE.<\/h2>

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Learn about dosage and administration<\/span><\/a><\/div>\n<\/div>
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References<\/h3><\/div>\n\n\n\n
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  1. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phosphodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE trials). Am J Respir Crit Care Med<\/em>. 2023;208(4):406-416. doi:10.1164\/rccm.202306-0944OC<\/li>\n<\/ol>\n<\/div>\n\n\n\n
    <\/div>\n","protected":false},"excerpt":{"rendered":"

    Please see additional Warnings and Precautions within the Select Safety Information, including acute episodes of bronchospasm, paradoxical bronchospasm, and psychiatric events including…<\/p>\n","protected":false},"author":605,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[8],"ga4_page_birn_id":[],"ga4_page_branding":[25],"ga4_page_businessunit":[30],"ga4_page_campaign":[],"ga4_page_content_purpose":[81],"ga4_page_customer_journey_stage":[102],"ga4_page_customer_specialty":[163],"ga4_page_experience":[],"ga4_page_indication":[324],"ga4_page_material_intent":[364],"ga4_page_product":[],"ga4_page_region":[748],"ga4_page_therapeuticarea":[814],"user_role":[],"mhh-area-of-interest":[],"access":[],"user_status":[],"class_list":["post-62","page","type-page","status-publish"],"yoast_head":"\nAdverse Reactions for 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