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1. WELCOME

Welcome to www.onzetra.com, an official website of Avanir Pharmaceuticals, Inc. (“Avanir”). This Terms of Use Agreement, together with the Privacy Policy, (the “Agreement”) sets forth the terms and conditions governing your registration to use www.onzetra.com (the “Website”). For the purposes of this Agreement, Avanir includes the company, any subsidiaries, affiliates, and each of their members, officers, agents, partners and employees. The terms “you” or “your” each refers to you as the user of the Website.

THIS WEBSITE IS NOT INTENDED AS A SUBSTITUTE FOR MEDICAL CARE BY AN APPROPRIATE HEALTH CARE PROVIDER. YOU SHOULD CONSULT YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL REGARDING ANY MEDICAL CONDITION FOR DIAGNOSIS AND TREATMENT AND THE APPROPRIATE USE OF [ALL MEDICATIONS/NAME OF DRUG]. THE CONTENT AND SERVICES ON THIS WEBSITE ARE FOR INFORMATIONAL PURPOSES ONLY.

Use of the Website’s Services is intended solely for users who are at least 18 years of age. Individuals under the age of 18 are prohibited from using the Website’s Services. BY USING THIS WEBSITE YOU REPRESENT AND WARRANT THAT YOU ARE AT LEAST 18 YEARS OF AGE OR OLDER.

This Agreement may be updated, revised, supplemented, or modified by Avanir from time to time. Any such changes to the Agreement will be effective immediately upon posting on the Website. Avanir encourages You to review this Agreement periodically for changes.

2. ENTIRE AGREEMENT

This Agreement constitutes the entire agreement between you and Avanir regarding the Website, and supersedes and replaces any prior agreements/communications between you and Avanir. If any portion of this Agreement is declared or held unlawful, invalid, or unenforceable, then such portion of the Agreement will be deemed severed and will not affect the validity or enforceability of the remainder of the Agreement.

3. COPYRIGHTS AND TRADEMARKS

  1. Ownership

    To the best of its knowledge, Avanir owns or has the right to use all of the data, information, trademarks, service marks, text, images, streaming media, video, sounds, icons, and other content contained on this Website (the “Content”), and the copyrights, patents, trade secrets, right of publicity, and other intellectual property rights or proprietary rights therein, unless otherwise noted. You may review, download, and/or print one copy of the Content of this Website, but you may not make more than one copy of such Content, modify it in any way, distribute or transmit it to any other person or company, frame or otherwise display any of the Content of this Website on your own or any other website, or make any other use of it. Such copying, modification, distribution or transmission, display, or use is a breach of the Agreement and may infringe Avanir’s trademarks, service marks, copyrights, copyrights licensed to Avanir, rights of privacy and publicity of Avanir employees and others, and other intellectual property rights owned or licensed by Avanir.

  2. Notice and Procedure for Making Claims of Copyright Infringement

    Avanir respects the intellectual property rights of others. Avanir will not knowingly host or otherwise maintain content that infringes the copyright rights of others. As such, Avanir has designated an agent to receive notifications of alleged copyright infringement on the Website. If you believe that your work has been used in a way that constitutes copyright infringement, please send a notice including all of the following information: (1) a description of the work; (2) a description of the location of the work on the Website, including the URL; (3) your name, address, telephone number, and email address; (4) a signed statement by you that you have a good faith belief that the disputed use is unauthorized under current law; and (5) a signed statement by you that you believe, under penalty of perjury, that your allegations are true and that you are the copyright owner or acting on behalf of the copyright owner. Please submit these materials as follows:

    DMCA Designated Agent
    30 Enterprise, Suite 400
    Aliso Viejo, CA 92656
    Email: DMCA@avanir.com

4. LINKS

  1. Links to the Website

    You may create a link from your website to the home page of the Website, without prior written permission, through a plain-text link, namely www.avanir.com. You may not use any trademarks or service marks as links to the Website from other websites, or as machine-readable search terms such as metatags. Avanir reserves the right to revoke your permission to link to the Website at its absolute and sole discretion. Any third party website that links to the Website agrees that it: (1) will not create a frame around content of the Website; (2) will not replicate the content of the Website; (3) will not state or imply that Avanir sponsors or endorses the thirdparty website; (4) will not libel or present false or misleading information of any kind, including defamatory or disparaging information about Avanir; and (5) will not contain any content that may be construed as illegal, immoral, offensive, controversial, or inappropriate. The posting or creation of any link to the Website signifies that you have read and agree to abide by this Agreement. If you believe that any third-party website that links to the Website contains illegal, offensive, or inappropriate content, please contact Avanir.

  2. Links from the Website

    Links to other websites or internet locations controlled, owned, and operated by third parties (“third-party sites”) from the Website have been provided only for your entertainment or convenience. Avanir does not endorse, sponsor, or approve of any content of such third-party sites. Avanir has no control over any third-party sites that you may access through the Website, and is not responsible for the content or accuracy of the content of any such website or location. If you access any other website or Internet location through the Website, you do so at your own risk. If you believe that any link on the Website leads to an illegal, offensive, or inappropriate website, please contact Avanir.

5. WEBSITE SERVICES

For your convenience, information, or entertainment, the Website may offer you the opportunity to submit postings in connection with various features of the Website, including blog posts, questionnaires, images, and articles, and to register to receive information, newsletters, and alerts (the “Services”). You must be at least 18 years of age to participate in any Services. You must also (a) provide accurate and complete Personal Information (as defined in the Privacy Policy), which will be collected pursuant to the Privacy Policy of the Website, and (b) agree to be bound by the Agreement, including the Privacy Policy.

You must use the Services in a responsible manner. You must not transmit any materials of any kind (“Content”) in connection with any Service(s) that:

  1. restricts or inhibits any other user from using and enjoying the Website;
  2. is unlawful, threatening, abusive, bigoted, hateful, libelous, defamatory, obscene, vulgar, offensive, pornographic, profane, sexually explicit, or indecent;
  3. constitutes, advocates, or encourages conduct that would constitute or give rise to a criminal offense, civil liability, or other violation of any local, state, national, or international law;
  4. violates, plagiarizes, or infringes the rights of third parties including, without limitation, copyright, trademark, patent, rights of privacy or publicity, or any other proprietary right;
  5. constitutes or may be perceived or interpreted as medical or health care advice;
  6. constitutes or may be perceived or interpreted as financial or investment advice;
  7. contains a virus or other harmful component;
  8. contains any information, software, or other material of a commercial nature;
  9. contains advertising, promotions, or commercial solicitations of any kind;
  10. constitutes or contains false or misleading indications of origin or statements of fact; and/or
  11. contains material irrelevant to the subject matter of the Service(s).

Avanir has the right, but not the obligation, in its sole discretion, to review, edit, or delete any Content transmitted in any Service that: (1) violates any term of this Agreement; or (2) is otherwise illegal, offensive, or inappropriate. Upon such violation, Avanir will have the sole discretion to terminate your access to the Website. Avanir reserves the right to fully cooperate with any law enforcement authorities or court orders requesting or directing Avanir to disclose Personal Information of anyone who uses the Website and/or the Services.

As more fully explained in the Privacy Policy, to provide, maintain, and improve the Services Avanir may collect personally identifying information that you affirmatively provide to us, including, without limitation, your name, address, telephone number, social security number, and/or e-mail address as well as your health information such as your medical condition(s), medical history, prescription, insurance information, physician, etc. (“PII”). If you are a physician, Avanir may collect additional information that you affirmatively provide to us, including, without limitation, your specialty, National Provider Identifier, medical license number, and certain generic patient and practice information, but not protected health information or personally identifying information regarding such patients.

You assume all risks associated with your Content, including anyone’s reliance on its quality, accuracy, or reliability, or any disclosure by you of information in your Content that makes you personally identifiable. You may not imply that your Content is in any way sponsored or endorsed by Avanir.

Although Avanir may from time to time monitor or review Content submitted in response to blog posts, questionnaires, articles, and the like on the Website, Avanir is under no obligation to do so and assumes no responsibility or liability arising from the posting of any Content or for any error, defamation, libel, slander, omission, falsehood, obscenity, pornography, profanity, danger, or inaccuracy contained therein. Display of any Content in any Service(s) does not constitute approval or endorsement by Avanir. If you believe that any posting to the Website is illegal, offensive, or inappropriate, please contact privacy@avanir.com.

Content submitted to the Website by electronic mail or otherwise, including any data, questions, comments, suggestions, information, images, or the like are, and will be treated as, non-confidential and nonproprietary. By submitting Content to the Website and/or using any Service(s), you acknowledge that any information disclosed by you therein may be used by Avanir in any manner it sees fit, including, for example, publicly displaying it, reformatting it, incorporating it into advertisements and other works, creating derivative works from it, promoting it, distributing it, and allowing others to do the same in connection with their own websites and media platforms.

By posting Content on the Website, you automatically grant to Avanir an irrevocable, perpetual, non-exclusive, royalty-free, fully paid-up, worldwide right and license to (i) use, copy, store, perform, display, reproduce, record, play, adapt, modify and distribute the Content, (ii) prepare derivative works of the Content or incorporate the Content into other works, and (iii) grant and authorize sublicenses of the foregoing in any media now known or hereafter created. You represent and warrant that any use of your Content by Avanir does and will not infringe or violate the rights of any third party.

6. SOCIAL MEDIA

Avanir maintains social media pages on various websites (including, but not limited to Facebook and Twitter). In addition, you may be able to use your social media account to access the Website and Services. Avanir encourages you to post, comment, and interact with Avanir and other users on these social media pages and the Website using the Services. However, you assume all risk for your interactions with other users, including online interactions and physical interactions.

Avanir may use your comments and other materials obtained from Avanir’s social media pages and/or on the Website in connection with marketing and advertising campaigns. Such comments and other materials may be used by Avanir in a number of different ways, including publicly displaying them, reformatting them, incorporating them into advertisements and other works, creating derivative works from them, promoting them, distributing them, and allowing others to do the same in connection with their own websites and media platforms.

All content and posts on Avanir’s social media pages are bound by the terms and conditions of the social media websites as displayed on those websites. Avanir has the right, but not the obligation, in its sole discretion, to review, edit, or delete any content and posts from Avanir’s social media pages that are illegal, offensive, or inappropriate.

7. CONSENT FOR SMS/TEXTING SERVICES; SMS OPT-IN; TCPA

Consent to receive marketing text messages is not required as a condition of purchasing any goods or services. Consent may be revoked at any time and by reasonable means, as described below.

  1. Consent for SMS/Texting Services

    If you provide a mobile number to Avanir, you consent to receive marketing and other information about Avanir, its research, its products, medical conditions, and/or other information via text and/or SMS to your mobile device. You may receive approximately [9] text and/or SMS messages per week from us. While Avanir does not charge to send or receive text messages, messages and data rates may apply. Please consult with your wireless carrier for applicable text messaging fees. Supported mobile service providers include: Alltel (part of Verizon), Appalachian Wireless, AT&T, Bluegrass Cellular, Boost Mobile, Cellcom, Cellular One from Dobson (part of AT&T), Cellular One of East Central Illinois, Cellular South, Centennial Wireless, Cincinnati Bell, Cox Wireless, Immix Wireless, Nextel (part of Sprint), nTelos Wireless, Revol Wireless, Sprint, T-Mobile, Unicel, US Cellular, Verizon Wireless, Virgin Mobile USA, and West Central Wireless. Please note T-Mobile is not liable for delayed or undelivered messages.

    We may modify or terminate our messaging services from time to time, for any reason and without notice, including the right to terminate text messaging without notice, without liability to you, any other user or a third party.

  2. SMS Opt-In and Opt-Out

    To receive SMS messages from Avanir, you must opt-in to such message by replying YES to a SMS message that will be sent by Avanir or its service provider to you. If you opt-in to such SMS message program, you consent to the receipt of recurring messages from Avanir or its service provider and such messages may be sent using an automatic telephone dialing system. To cancel such text messaging, send STOP to [insert program short code]. For help or information regarding text messaging, send HELP to [insert program short code] or contact Avanir customer service at 855–468-3339. You expressly consent to receipt of a text message to confirm your “STOP” request. Standard message and data rates apply.

  3. Telephone Consumer Protection Act (“TCPA”)

    When you visit the Website, text, call, fax, or send emails to us, you communicate with us electronically and consent to receive communications from us electronically. We may communicate with you by: (a) emailing the email address indicated in your communications with us; (b) posting general notices on the Website; or (c) posting messages that are displayed to you when you log in to or access the Website. You agree that all agreements, notices, disclosures and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing.

    TCPA Disclosure: To ensure that consumer’s inquiries are handled promptly, courteously, and accurately, communications between you and Avanir, including phone calls between you and us or any of our affiliates, agents, assigns and service providers, may be monitored and recorded to enhance service to you. You consent to this monitoring and recording. You agree that Avanir may from time to time make calls, send emails, fax, and/or send text messages to you at any telephone number associated with your account, including wireless telephone numbers that could result in charges to you. The manner in which these communications are made to you may include, but is not limited to, the use of prerecorded/artificial voice messages and/or automatic telephone dialing system. You further agree that Avanir may send e-mails to you at any e-mail address you provide us or use other electronic means of communication to the extent permitted by law.

8. PROHIBITED USES

This Website and all of its Content is offered solely for your own personal, informational, non-competing use. In addition to the requirements set forth in other sections of the Agreement, you agree not to access and/or use the Website for any purpose not expressly authorized by the Agreement and/or to transmit, post, or distribute to the Website content that:

  1. constitutes an advertisement or solicitation of business of any kind, including but not limited to spam, chain letters, and pyramid schemes;
  2. contains or constitutes software, computer programs, or routines of any kind, including but not limited to viruses, bots, worms, and spiders;
  3. collects information about others, including but not limited to users’ e-mail addresses or other personal information;
  4. imposes an unreasonable load on the Website’s infrastructure; and/or
  5. reverse engineers or decompiles the software comprising or included in the Website.

9. YOUR ACCOUNT

If you create an Account on this Website you are responsible for maintaining the confidentiality of the username and password you designate to register for the Website’s Services, and you are solely responsible for all activities that occur under your username and password. You agree to immediately notify Avanir of any disclosure or unauthorized use of your username or password, or any other breach of security.

10. REMOVAL OF CONTENT POSTED BY MINORS

If you are less than 18 years of age (a “Minor”), you or your parent or guardian can request the removal of Content that you posted on the Website. To do so, please send an email to privacy@avanir.com and include the following information:

  • a link to the Website location where the Content is posted; and
  • the specific Content you are requesting to have removed from the Website.

The removal of this Content does not ensure complete or comprehensive removal of the Content posted on the Website (e.g., the content may remain on Avanir’s servers in some form). Avanir also will not remove the Content if:

  • any other provision of federal or state law requires Avanir to maintain the Content;
  • the Content is stored, republished, or reposted to the Website by a third party other than the Minor;
  • Avanir anonymizes the Content posted by the Minor, so that the Minor cannot be individually identified;
  • the Minor has received compensation or other consideration for providing the Content.

11. DISCLAIMER OF WARRANTIES

ALL CONTENT OF THIS SITE, INCLUDING, BUT NOT LIMITED TO, ANY INFORMATION OR ADVICE THAT MAY BE GIVEN OVER THIS WEBSITE, ARE PROVIDED “AS IS,” AND ALL USE OF THIS SITE IS AT YOUR OWN RISK. AVANIR DISCLAIMS, AND YOU HEREBY WAIVE, ANY AND ALL WARRANTIES AND LIABILITIES OF AVANIR, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.

YOU ACKNOWLEDGE THAT AVANIR DOES NOT REPRESENT OR WARRANT THAT THIS WEBSITE WILL BE ACCESSIBLE WITHOUT INTERRUPTION OR THAT THIS WEBSITE OR THE SERVER THAT MAKES THIS WEBSITE AVAILABLE ARE FREE FROM ERRORS, DEFECTS, DESIGN FLAWS, OMISSIONS, VIRUSES, OR OTHER HARMFUL COMPONENTS.

SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.

Avanir does not guarantee, warrant, or make any representations regarding the use of the information or materials on this Website in terms of its correctness, accuracy, reliability, or otherwise, and information on this Website may contain technical inaccuracies or typographical errors. For example, some information or materials on this Website is provided courtesy of third parties. While Avanir uses reasonable efforts to include accurate and up-to-date information on this Website, errors or omissions may occur. In addition, information may be changed or updated without notice.PLEASE DO NOT RELY ON THE ACCURACY OF ANY INFORMATION ON THE WEBSITE TO MAKE ANY HEALTHCARE DECISION. PLEASE TALK TO YOUR HEALTHCARE PROFESSIONAL REGARDING THE DIAGNOSIS AND TREATMENT OF ANY MEDICAL CONDITION.

Statements from third-party users contain opinions, viewpoints, advice, offers, or other third-party content. All such third-party content is the responsibility of the respective authors thereof and should not necessarily be relied upon. Such third-party authors are solely responsible for such content.

AVANIR DOES NOT: (I) GUARANTEE THE ACCURACY, LEGITIMACY, COMPLETENESS, OR USEFULNESS OF ANY THIRD-PARTY CONTENT ON THE WEBSITE, OR (II) ADOPT, ENDORSE, OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR RELIABILITY OF ANY THIRD-PARTY OPINION, ADVICE, OR STATEMENT. UNDER NO CIRCUMSTANCES WILL AVANIR BE RESPONSIBLE OR LIABLE FOR ANY LOSS OR DAMAGES RESULTING FROM YOUR RELIANCE ON THIRD-PARTY STATEMENTS OR OTHER CONTENT POSTED ON THE WEBSITE, OR OTHERWISE TRANSMITTED TO OR BY ANY USERS.

12. LIMITATION OF LIABILITY

USE OF THIS WEBSITE IS AT YOUR OWN RISK. IN NO EVENT WILL AVANIR BE LIABLE TO ANY PARTY FOR ANY DIRECT, INDIRECT, SPECIAL OR OTHER TYPES OF CONSEQUENTIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF THIS WEBSITE, THE CONTENT, THE SERVICES, OR ANY OTHER HYPERLINKED WEBSITE, WHETHER BASED ON CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE, INCLUDING WITHOUT LIMITATION, DEATH, DISABILITY, LOST PROFITS, BUSINESS INTERRUPTION, OR LOSS OF DATA, EVEN IF AVANIR IS EXPRESSLY ADVISED ABOUT THE POSSIBILITY OF SUCH DAMAGES.

13. INDEMNIFICATION

You agree to indemnify, defend, and hold harmless Avanir from and against all liabilities, claims, expenses, or demands, including reasonable attorneys’ fees and amounts paid to settle claims, made by any third-party due to or arising from the content you submit, post, or transmit to or through the Website, your use of the Website, your violation of the Agreement, or your violation of any rights of another.

14. NO WAIVER

The failure of Avanir to enforce any provision of the Agreement, or to respond to a breach of the Agreement, by you or other parties does not in any way constitute a waiver of Avanir’s rights to subsequently enforce any provision of the Agreement against you or any other party.

15. NOTICES

Subject to applicable laws and regulations, Avanir may give notices to users of the Website, at Avanir’s option, by posting a message on the Website, by e-mail, by text or by regular mail.

16. CALIFORNIA CIVIL CODE SECTION 1789.3

Under California Civil Code Section 1789.3, California consumers are entitled to the following specific consumer rights notice: The Complaint Assistance Unit of the Division of Consumer Services of the California Department of Consumer Affairs may be contacted in writing at 1625 N. Market Blvd., Suite N-112, Sacramento, California 95834, or by telephone at 1 (800) 952-5210.

17. LOCATION AND GOVERNING LAW

The Website is controlled, operated and administered by Avanir from its offices within the United States of America. Avanir makes no representation that materials on this Website are appropriate or available for use at locations outside of the U.S. and access to any such materials from territories where their contents are illegal is prohibited. You may not use the Website or export the Content in violation of U.S. export laws or regulations. If you access this Website from a location outside of the U.S., you are responsible for compliance with all local laws and regulations.

The Agreement and all matters relating to your access to or use of the Website, including all disputes, shall be governed by and construed in accordance with the laws of the state of California, without regard to choice of law or conflicts of law principles.

You hereby agree that any and all disputes arising out of or in connection with using the Services, and all matters relating to your access to or use of the Website, shall be resolved by arbitration pursuant to this provision and the code of procedures of either the judicial Arbitration and Mediation Services, Inc. (“JAMS”) or the American Arbitration Association (“AAA”), as selected by Avanir. The arbitration shall be held in California. To the extent the parties are permitted under this Agreement to initiate litigation in court, any litigation against Avanir may be commenced only in the federal or state courts located in California. You hereby irrevocably consent to the jurisdiction of those courts for such purposes.

18. U.S. GOVERNMENT RIGHTS

To the extent any part of the Website and/or Services are found to be commercial computer software, as such term is defined in 48 C.F.R. §2.101, if you are an agency of the US Government or any contractor thereof, you receive only those rights with respect to the Services as are granted to all other users under license, in accordance with (a) 48 C.F.R. §227.7201 through 48 C.F.R. §227.7204, with respect to the Department of Defense and their contractors, or (b) 48 C.F.R. §12.212, with respect to all other US Government licensees and their contractors.

19. CHANGES THE TO AGREEMENT; ASSIGNMENT

The Agreement is effective as of the date first written above. Avanir reserves the right to modify the Agreement at its sole discretion. If Avanir decides to change the Agreement, Avanir will post those changes here. We encourage you to visit this section of our site regularly in order to remain informed of any changes. Changes to the Agreement will not apply retroactively and become effective as of the time they are posted to the Website. Your continued use of the Website following changes to our terms constitutes your acceptance of our amended terms. Avanir reserves the right to assign or transfer our rights and obligations under t

20. HEADINGS

The section/paragraph headings appearing in the Terms of Use are inserted only as a matter of convenience and in no way define, limit, construe, or describe the scope of extent of such section or in any way affect such section/paragraph.

21. QUESTIONS

If you have any questions about the Agreement, the Website, or your dealings with Avanir, you can write to Avanir at 30 Enterprise, Suite 400, Aliso Viejo, CA 92656.

MLR-AVN-US-0193-0619

Tap for Safety Information

ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

Important Safety Information

What important information should I know about ONZETRA Xsail?
ONZETRA Xsail may cause serious side effects, including:

ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

Important Safety Information

What important information should I know about ONZETRA Xsail?

ONZETRA Xsail may cause serious side effects, including:

  • Heart attack and other heart problems, which may lead to death. Stop using ONZETRA Xsail and get emergency medical help right away if you have any symptoms of a heart attack like shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away
  • Changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • Stomach and intestinal problems (gastrointestinal and colonic ischemic events)
  • Problems with blood circulation to your legs and feet (peripheral vascular ischemia)
  • Serious allergic reactions (symptoms include hives; tongue, mouth, lip, or throat swelling; problems breathing)
  • Medication overuse headaches. Some people who use ONZETRA Xsail too many times may have worse headaches. If your headaches get worse your doctor may decide to stop your treatment with ONZETRA Xsail
  • Serotonin syndrome, a rare but serious problem that can happen in people using ONZETRA Xsail, especially if ONZETRA Xsail is used with antidepressant medicines called SSRIs, SNRIs, or TCAs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; trouble walking; or nausea, vomiting, or diarrhea
  • Seizures. Seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of ONZETRA Xsail are abnormal taste, discomfort of your nose or throat, runny nose, and stuffy nose. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Who should not take ONZETRA Xsail?
Do not take ONZETRA Xsail or stop using ONZETRA Xsail if you:

  • Have heart problems or a history of heart problems
  • Have had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • Have uncontrolled high blood pressure
  • Have hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your doctor
  • Have peripheral vascular disease (narrowing of blood vessels to the legs, arms, stomach, intestines, or kidneys)
  • Have taken other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications. Ask your doctor for a list of these medicines if you are not sure
  • Are taking a medicine called a monoamine oxidase inhibitor (MAOI). MAOIs cannot be taken within 14 days before or after taking ONZETRA Xsail
  • Have severe liver problems
  • Have an allergy to sumatriptan, the medicine in ONZETRA Xsail, or any of the components in ONZETRA Xsail

What should I tell my healthcare provider before taking ONZETRA Xsail?
Before you take ONZETRA Xsail, tell your doctor about all your medical conditions and all the medicines you take, including prescription medicines, especially antidepressants, and all over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ONZETRA Xsail?
ONZETRA Xsail can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088.

For additional Important Safety Information about ONZETRA Xsail, please see the full Prescribing Information, including Patient Information and Instructions for Use.