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Medication Guide — Morphine Sulfate

Patient-friendly FDA guidance and safety information.

Last updated · May 12, 2026Source: DailyMed ↗
Boxed Warning

Addiction, Abuse, and Misuse

Morphine sulfate exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing morphine sulfate extended-release tablets, and monitor all patients regularly for the development of these behaviors and conditions .

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products . Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate. Monitor for respiratory depression, especially during initiation of morphine sulfate or following a dose increase.Instruct patients to swallow morphine sulfate extended-release tablets whole; crushing, chewing, or dissolving morphine sulfate extended-release tablets can cause rapid release and absorption of a potentially fatal dose of morphine .

Accidental Ingestion

Accidental ingestion of even one dose of morphine sulfate, especially by children, can result in a fatal overdose of morphine .

Neonatal Opioid Withdrawal Syndrome (NOWS)

Prolonged use of morphine sulfate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions, Drug Interactions (7)].

  • Reserve concomitant prescribing of morphine sulfate and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning .

  • Morphine sulfate exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing, and monitor regularly for these behaviors and conditions.
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
  • Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate extended-release tablets are essential. Instruct patients to swallow morphine sulfate extended-release tablets whole to avoid exposure to a potentially fatal dose of morphine.
  • Accidental ingestion of morphine sulfate extended-release tablets, especially by children, can result in a fatal overdose of morphine.
  • Prolonged use of morphine sulfate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.5, 7)

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

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MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration.

MEDICATION GUID

MORPHINE (MOR feen) SULFATE EXTENDED-RELEASE TABLETS, CII

Rx only

Morphine sulfate extended-release tablets are:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not for use to treat pain that is not around-the-clock.

Important information about morphine sulfate extended-release tablets:

  • Get emergency help or call 911 right away if you take too much morphine sulfate extended-release tablets (overdose). When you first start taking morphine sulfate extended-release tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • Taking morphine sulfate extended-release tablets 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.
  • Never give anyone else your morphine sulfate extended-release tablets. They could die from taking it. Selling or giving away morphine sulfate extended-release tablets is against the law.
  • Store morphine sulfate extended-release tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take morphine sulfate extended-release tablets if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before taking morphine sulfate extended-release tablets, tell your healthcare provider if you have a history of:

 • head injury, seizures   

 • liver, kidney, thyroid problems

 • problems urinating   

 • pancreas or gallbladder problems

 • abuse of street or prescription drugs, alcohol addiction,

opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

  • noticing your pain getting worse. If your pain gets worse after you take morphine sulfate extended-release tablets, do not take more of morphine sulfate extended-release tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking morphine sulfate extended-release tablets.
  • pregnant or planning to become pregnant.  Prolonged use of morphine sulfate extended-release tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with morphine sulfate. It may harm your baby living in a household where there are small children or someone who has abused street or prescription drugs
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking morphine sulfate extended-release tablets with certain other medicines can cause serious side effects.

When taking morphine sulfate extended-release tablets:

  • Do not change your dose. Take morphine sulfate extended-release tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest duration.
  • Take your prescribed dose every 8 to 12 hours, as directed by your healthcare provider. Do not take more than your prescribed dose. If you miss a dose, take your next dose at the usual time.
  • Swallow morphine sulfate extended-release tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject morphine sulfate extended-release tablets because this may cause you to overdose and die.
  • Call your healthcare provider if the dose you are ta king does not control your pain.
  • Do not stop taking morphine sulfate extended-release tablets without talking to your healthcare provider.

Dispose of expired, unwanted, or unused morphine sulfate extended-release tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of morphine sulfate extended-release tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking morphine sulfate extended-release tablets DO NOT:

  • Drive or operate heavy machinery,until you know how morphine sulfate extended-release tablets affect you. Morphine sulfate extended-release tablets can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with morphine sulfate extended-release tablets may cause you to overdose and die.

The possible side effects of morphine sulfate extended-release tablets are:

  • Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away 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.

These are not all the possible side effects of morphine sulfate extended-release tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

www.sunpharma.com or call 1-800-818-4555

September 2023                                 

FDA-10

Sources

RxCUI: 891874

NDC: 71335-3080

Last fetched: May 12, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.