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Medication Guide — Meperidine Hydrochloride

Patient-friendly FDA guidance and safety information.

Last updated · May 13, 2026Source: DailyMed ↗
Boxed Warning

Risk of Medication Errors

Ensure accuracy when prescribing, dispensing, and administering Meperidine Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other Meperidine Hydrochloride Oral Solutions of different concentrations can result in accidental overdose and death .

Addiction, Abuse, and Misuse

Because the use of Meperidine Hydrochloride Tablets and Oral Solution 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 and reassess all patients regularly for the development of these behaviors and conditions .

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Meperidine Hydrochloride Tablets and Oral Solution, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Meperidine Hydrochloride Tablets or Oral Solution are essential .

Accidental Ingestion

Accidental ingestion of Meperidine Hydrochloride Tablets and Oral Solution, especially by children, can result in a fatal overdose of meperidine .

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. Reserve concomitant prescribing of Meperidine Hydrochloride Tablets and Oral Solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate .

Neonatal Opioid Withdrawal Syndrome (NOWS)

Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery .

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription .

Cytochrome P450 3A4 (CYP3A4) Interaction

The concomitant use of Meperidine Hydrochloride Tablets or Oral Solution with all cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in meperidine plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 (CYP3A4) inducer may result in an increase in meperidine plasma concentration. Monitor patients receiving Meperidine Hydrochloride Tablets or Oral Solution, and any CYP3A4 inhibitor or inducer .

Concomitant use of Meperidine Hydrochloride Tablets and Oral Solution with Monoamine Oxidase Inhibitors (MAOIs)

Concomitant use of Meperidine Hydrochloride Tablets or Oral Solution with monoamine oxidase inhibitors (MAOIs) can result in coma, severe respiratory depression, cyanosis, and hypotension. Use of Meperidine Hydrochloride Tablets or Oral Solution with MAOIs within last 14 days is contraindicated .

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MEPERIDINE HYDROCHLORIDE TABLETS AND ORAL SOLUTION

See full prescribing information for complete boxed warning.

  • Ensure accuracy when prescribing, dispensing, and administering Meperidine Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL, and other Meperidine Hydrochloride Oral Solutions of different concentrations can result in accidental overdose and death.
  • Meperidine Hydrochloride Tablets and Oral Solution expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and reassess regularly for these behaviors and conditions.
  • Serious, life-threatening, or fatal respiratory depression may occur, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Meperidine Hydrochloride Tablets or Oral Solution are essential.
  • Accidental ingestion of Meperidine Hydrochloride Tablets or Oral Solution, especially by children, can result in a fatal overdose of meperidine.
  • 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. (5.7, 7)
  • Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.
  • Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.
  • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in fatal overdose of meperidine. (5.6, 7)
  • Concomitant use of Meperidine Hydrochloride Tablets or Oral Solution with monoamine oxidase inhibitors (MAOIs) can result in coma, severe respiratory depression, cyanosis and hypotension. Use of Meperidine Hydrochloride Tablets or Oral Solution with MAOIs within the last 14 days is contraindicated. (4, 5.8, 6)

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.

On this page

Medication Guide

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

Meperidine Hydrochloride Tablets and Oral Solution, USP, CII

(me per’ i deen hye” droe klor’ ide)

Rx only

Meperidine Hydrochloride Tablets and Oral Solution are:

  • •A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage the relief short-term (acute) pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • •An 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.

Important information about Meperidine Hydrochloride Tablets and Oral Solution:

  • • Get emergency help or call 911 right away if you take too much Meperidine Hydrochloride Tablets or Oral Solution (overdose). When you first start taking Meperidine Hydrochloride Tablets or Oral Solution, 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. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
  • •Taking Meperidine Hydrochloride Tablets and Oral Solution with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), 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 Meperidine Hydrochloride Tablets and Oral Solution. They could die from taking it. Selling or giving away Meperidine Hydrochloride Tablets and Oral Solution is against the law.
  • •Store Meperidine Hydrochloride Tablets and Oral Solution away from children and in a safe location not accessible by others, including visitors to the home.

Do not take Meperidine Hydrochloride Tablets and Oral Solution if you have:

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

Before taking Meperidine Hydrochloride Tablets and Oral Solution, tell your healthcare provider if you have a history of:

  • •head injury, seizures
  • •problems urinating
  • •liver, kidney, thyroid problems
  • •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 Meperidine Hydrochloride Tablets or Oral Solution, do not take more of Meperidine Hydrochloride Tablets or Oral Solution without first talking to your healthcare provider. Talk to your healthcare provider if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking Meperidine Hydrochloride Tablets or Oral Solution.
  • • pregnant or planning to become pregnant. Use of Meperidine Hydrochloride Tablets or Oral Solution for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • • breastfeeding. Meperidine hydrochloride passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
  • •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 Meperidine Hydrochloride Tablets and Oral Solution with certain other medicines can cause serious side effects that could lead to death.

When taking Meperidine Hydrochloride Tablets or Oral Solution:

  • •Do not change your dose. Take Meperidine Hydrochloride Tablets and Oral Solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • •For acute (short-term) pain, you may only need to take Meperidine Hydrochloride Tablets or Oral Solution for a few days. You may have some Meperidine Hydrochloride Tablets or Oral Solution left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused Meperidine Hydrochloride Tablets and Oral Solution.
  • •Always use a graduated measuring device for Meperidine Hydrochloride Oral Solution to correctly measure your dose. Never use a household teaspoon or tablespoon to measure Meperidine Hydrochloride Oral Solution.
  • •Mix each dose of Meperidine Hydrochloride Oral Solution into one-half glass of water before swallowing.
  • •Take your prescribed dose every 3 or 4 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • •Call your healthcare provider if the dose you are taking does not control your pain.
  • •If you have been taking Meperidine Hydrochloride Tablets and Oral Solution regularly, do not stop taking Meperidine Hydrochloride Tablets or Oral Solution without talking to your healthcare provider.
  • •Dispose of expired, unwanted, or unused Meperidine Hydrochloride Tablets and Oral Solution by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking Meperidine Hydrochloride Tablets and Oral Solution DO NOT:

  • •Drive or operate heavy machinery, until you know how Meperidine Hydrochloride Tablets or Oral Solution affects you. Meperidine Hydrochloride Tablets or Oral Solution 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 Meperidine Hydrochloride Tablets or Oral Solution may cause you to overdose and die.

The possible side effects of Meperidine Hydrochloride Tablets and Oral Solution:

  • •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 Meperidine Hydrochloride Tablets and Oral Solution. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information go to dailymed.nlm.nih.gov.

www.hikma.comor call 1-800-962-8364

Distributed by: Hikma

Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

C50000733/04

Revised February 2026

Sources

RxCUI: 861455

NDC: 0054-3545

Last fetched: May 13, 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.