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Privacy Policy

The privacy of Site users' personal information is important to Purdue. This Privacy Policy describes information that may be collected about Site users; how Site user information is used; how Purdue protects it; and what choices Site users have on how that information is used.


  1. This Privacy Policy covers the following types of information:

    This Privacy Policy covers Purdue's treatment of personally identifiable information that Purdue collects when you are on this Web site, and when you use Purdue's services or click on Purdue's online advertisements on the Internet to access a Purdue Site. This Privacy Policy does not apply to the practices of companies that Purdue does not own or control, or to people that Purdue does not employ or manage. Information collection and use will be handled in the following manner set forth in this Privacy Policy.

  2. PERSONAL INFORMATION WE COLLECT

    Information we collect from visitors

    Visitors to Purdue Sites can access the Site's home page, and browse some areas of the site, without disclosing any personally identifiable information. We do track information provided to us by your browser, including the Site you came from (known as the referring URL), any Purdue online advertisements located on third party websites that you may have clicked on to access one of the Purdue Sites, the type of browser you use, the time and date of access, and other information that does not personally identify you. On some of our sites, you must register to access portions of the site.

    In addition, we gather information about you that is automatically collected by our Web server, such as your IP address and domain name. Purdue may use Web server and browser information to individually customize its offerings and presentations if you submit your personal information.

    Information we collect when you register

    Visitors registering for services on our Web sites are asked to provide identifying information, such as name, gender, and contact information. On the registration screen, we label which information is required for registration, and which information is optional and may be given at your discretion. Purdue Sites obtain visitors' consent before collecting personally identifiable information.

    Information from outside sources

    We may also collect information about physicians or other health care professionals who register on Purdue Sites from other sources in order to verify their licensure status and identity. In some cases, we ask customers for information after they register, such as credit card information. Where necessary (for example, to process an order for a purchase), our Web sites may contact financial or credit organizations to confirm customer credit card information.

    From time to time we may augment our existing user databases with legally obtained information from third parties. Some of this information may be personally identifiable, such as national change of address information. We do this to better target our information offerings and promotional campaigns and to provide pertinent offers in which we think you would be interested.

    Other information

    • We may also collect information that you voluntarily provide to us through responses to surveys, search functions, questionnaires, feedback, forms and the like.
    • On some of our Sites, we offer health assessment tools that ask you to provide self-assessment information.
    • We may also ask you to provide additional information such as your e-mail address if you want to obtain additional services or information or to resolve complaints or concerns.
  3. Purdue will take reasonable steps to safeguard any information you share with us. Purdue stores the information you provide about yourself in a database in order to provide you with the information you request. The information is stored for the lifetime of the database unless you request that it be removed.
  4. Purdue will limit the collection and use of your information that Purdue requires to deliver superior service to you, which includes advising you about Purdue's products, newsletters, services and other opportunities, and to administer Purdue's business.
  5. This Site is not intended or designed to attract children under the age of 13. We do not knowingly collect personally identifiable data from site visitors under the age of 13.
  6. Purdue will permit only authorized employees, consultants, third party vendors or other agents, who are trained in the proper handling of customer information, to have access to that information. Employees who violate Purdue's Privacy Policy will be subject to Purdue's normal disciplinary process.
  7. Except as described above, Purdue will not otherwise use or disclose any of your personally identifiable information, except to the extent reasonably necessary: (i) to correct technical problems and malfunctions, to technically process your information and to determine the effectiveness of our projects; (ii) to protect the security and integrity of our website; (iii) to protect our rights and property and the rights and property of others; (iv) to take precautions against liability; (v) to the extent required by law or to respond to judicial process; or (vi) to the enforcement agencies or for an investigation on a matter related to public safety, as applicable.
  8. Cookies, log files, and pixel-tags (Web beacons) are technologies used by the Purdue Sites to identify a user as the user moves through Purdue Sites, or as the user clicks on a Purdue online advertisement located on a third party website. Your browser allows us to place some information (session based IDs and/or persistent cookies) on your computer's hard drive that identifies the computer you are using. We may use cookies to personalize our Web sites and to track your usage across other Purdue Sites. Your Web browser can be set to allow you to control whether you will accept cookies, reject cookies, or to notify you each time a cookie is sent to you. If your browser is set to reject cookies, Web sites that are cookie-enabled will not recognize you when you return to the Web site, and some Web site functionality may be lost. The Help section of your browser will tell you how to prevent your browser from accepting cookies. On occasion, we contract with third parties to place cookies on your computer's hard drive. Although cookies do not normally contain personally identifiable information, if you have provided us information about you, we may associate your registration information with cookies or other tracking utilities our Web site places on your computer's hard drive. Associating a cookie with your registration data allows us to offer increased personalization and functionality. Without cookies, this functionality would not be possible. Some of our business partners may use cookies on our sites (for example, links to business partners). We do not want our business partners to use cookies to track our customers' activities once they leave our sites. However, we may not have total control over how our business partners may use cookies on our Web sites. In addition, we may use other tracking systems like pixel-tags. Pixel tags, sometimes called Web beacons, are similar in function to a cookie. But because of their insignificant size, it is not visible; though, they are used to pass certain information to our servers to personalize our Web sites and to track your usage across other Purdue Web sites where Purdue online advertisements are located. In addition, we may also use pixel tags in our HTML based e-mails.
  9. As a resource to Site visitors, Purdue may provide links to other websites. Site users should carefully review the privacy policies and practices of these websites, as Purdue cannot control or be responsible for the privacy practices of other Web sites.
  10. At any time, you can contact Purdue to remove your name from our marketing list.
  11. For the purpose of determining the effectiveness of our Site and other online marketing programs, Purdue may hire certain third party organizations that collect, analyze and report on non-personally identifiable data or provide website and/or program support services. To the extent possible, Purdue will require these organizations to conform to Purdue's Privacy Policy.
  12. THIRD PARTIES. Purdue may share some kinds of information with third parties as described below:
    • Companies and people who work for us: Purdue contracts with other companies and individuals to help Purdue provide services. For example, Purdue may host some of our Sites on another company's computers, hire technical consultants to maintain our Web-based health sites, or work with companies to remove repetitive information from customer lists, analyze data, provide marketing assistance, and provide customer service. In addition, if you are a health care professional, Purdue may validate your licensure status and other information against available databases that list licensed health care professionals. In order to perform their jobs, these other companies may have limited access to some of the personal information Purdue maintains about our users. Other companies may collect information on our behalf through their sites. This occasionally incorporates the use of frames on the site that will not show the URL you are visiting in the browser address window. We require such companies to comply with the terms of our privacy policies, to limit their access to any personal information to the minimum necessary to perform their obligations, and not to use the information they may access for purposes other than fulfilling their responsibilities to us. We use our best efforts to limit other companies' use of personally identifiable or health care information.
    • Promotional and informational offers: Sometimes Purdue sends offers to selected groups of customers. To accomplish this Purdue may use third parties working on behalf of Purdue. Purdue provides a variety of mechanisms for you to tell us you do not want to receive such promotional-informational offers. For example, Purdue may provide an opt-in box for customers to receive information that is sent by a third-party fulfillment house. You can elect not to receive promotional or informational material from us by following the instructions to opt-out as mentioned or included in each of our programs that Purdue sends to you.
    • Legal requirements: We may release account and other personal information when Purdue believes that its release is required to comply with the law, regulations, rules or local ordinances. We may release personal health information if, in our judgment after review by an attorney, the release is compelled by law or regulation, or if the release may be necessary to prevent the death or serious injury of an individual.

By using this Site and the contents and services available to you on our Website, you consent to our collection and use of your information as described above. Purdue will continuously assess its practices to ensure that your privacy is respected. Purdue may amend this Privacy Policy from time to time. If Purdue makes any substantial changes in the way Purdue uses your personal information Purdue will notify you by posting a prominent announcement on Purdue's Website.

See also Purdue's Terms & Conditions for additional information.

Purdue Pharma L.P. Privacy Policy updated: November 15, 2012


Social Security Number Protection Policy

Purdue is committed to the responsible protection of your Social Security number ("SSN"). This notice applies to any SSN that Purdue collects in the course of our business. Purdue protects the confidentiality of SSNs, including by maintaining manual and/or electronic security procedures to guard against unauthorized access to SSNs. Purdue also limits access to SSNs, including by only granting access to SSNs to Purdue employees who use that information to perform their job-related duties. In addition, Purdue discloses SSNs to third parties only where necessary for business purposes and not otherwise prohibited by law.



WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; WITHDRAWAL SYNDROME IN NEWBORNS; and RISKS FROM USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially in children, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

Use with Benzodiazepines or Other CNS Depressants

Use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, can result in severe drowsiness, breathing problems, coma and death.

What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate.

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant).

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare provider if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death.

  • Get emergency help right away if you take too much Butrans (overdose).

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing.

  • Taking Butrans with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Do not use these together unless you are directed to do so by your healthcare provider.

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law.

  • Accidental exposure, especially in a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch).

  • Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

  • Tell your healthcare provider if you are breastfeeding. Breastfeeding is not recommended during treatment with Butrans. It may harm your baby.

  • Tell your healthcare provider about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death.

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die.

  • Butrans could cause adrenal insufficiency, a potentially life-threatening condition which may cause symptoms of nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Seek medical attention if you experience these symptoms.

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position.

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma.

  • Do not stop using Butrans without talking to your healthcare provider.

  • Tell your healthcare provider if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or prolonged direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death.

  • Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

  • Butrans may increase the frequency of seizures in patients who experience seizures and may increase the risk of seizures in other settings associated with seizures. Tell your healthcare provider if you have a history of seizures.

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely.

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare provider if you have any of these symptoms and they are severe.

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indications and Usage
What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate.

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant).

Important Safety Information

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; WITHDRAWAL SYNDROME IN NEWBORNS; and RISKS FROM USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially in children, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

Use with Benzodiazepines or Other CNS Depressants

Use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, can result in severe drowsiness, breathing problems, coma and death.

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare provider if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death.

  • Get emergency help right away if you take too much Butrans (overdose).

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing.

  • Taking Butrans with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Do not use these together unless you are directed to do so by your healthcare provider.

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law.

  • Accidental exposure, especially in a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch).

  • Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

  • Tell your healthcare provider if you are breastfeeding. Breastfeeding is not recommended during treatment with Butrans. It may harm your baby.

  • Tell your healthcare provider about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death.

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die.

  • Butrans could cause adrenal insufficiency, a potentially life-threatening condition which may cause symptoms of nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Seek medical attention if you experience these symptoms.

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position.

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma.

  • Do not stop using Butrans without talking to your healthcare provider.

  • Tell your healthcare provider if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or prolonged direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death.

  • Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

  • Butrans may increase the frequency of seizures in patients who experience seizures and may increase the risk of seizures in other settings associated with seizures. Tell your healthcare provider if you have a history of seizures.

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely.

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare provider if you have any of these symptoms and they are severe.

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; WITHDRAWAL SYNDROME IN NEWBORNS; and RISKS FROM USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially in children, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

Use with Benzodiazepines or Other CNS Depressants

Use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, can result in severe drowsiness, breathing problems, coma and death.

What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate.

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant).

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare provider if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death.

  • Get emergency help right away if you take too much Butrans (overdose).

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing.

  • Taking Butrans with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Do not use these together unless you are directed to do so by your healthcare provider.

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law.

  • Accidental exposure, especially in a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch).

  • Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

  • Tell your healthcare provider if you are breastfeeding. Breastfeeding is not recommended during treatment with Butrans. It may harm your baby.

  • Tell your healthcare provider about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death.

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die.

  • Butrans could cause adrenal insufficiency, a potentially life-threatening condition which may cause symptoms of nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Seek medical attention if you experience these symptoms.

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position.

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma.

  • Do not stop using Butrans without talking to your healthcare provider.

  • Tell your healthcare provider if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or prolonged direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death.

  • Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

  • Butrans may increase the frequency of seizures in patients who experience seizures and may increase the risk of seizures in other settings associated with seizures. Tell your healthcare provider if you have a history of seizures.

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely.

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare provider if you have any of these symptoms and they are severe.

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.