Accidental Overdose

Accidental Overdose2025-06-26T21:14:33-04:00

What is an accidental opioid overdose?

An opioid overdose happens when the body has been overloaded with either a medication or an illicit opioid.

Accidents can lead to overdoses because while opioids affect the nerves that feel pain, they also affect the nerves that control breathing. If this slows breathing too much, a person can fall unconscious, experience a coma, brain damage or death.

It only takes 4 minutes

Permanent brain damage can occur within four minutes of oxygen deprivation.

Accidental opioid overdose is more common than you think

Accidental drug overdose is the leading cause of accidental death in the US.; most of these involve opioids.

Even when opioids are taken as prescribed by a healthcare provider, accidents can happen. You could accidentally take more than recommended. Your medicines may interact in ways you didn’t expect. You may have a medical condition that puts you at more risk than you thought. Someone could get into your medicine cabinet.

The bottom line: accidents happen

Just like you wear your seatbelt and keep a fire extinguisher in your home, having KLOXXADO® (naloxone HCl) Nasal Spray 8 mg in your first aid kit is a simple safety measure that could save a life.

Let your household members and friends know where to find KLOXXADO® so they can help in case of an opioid emergency.

How to recognize an opioid overdose emergency

During an opioid overdose breathing can decline drastically or stop, causing brain damage and death. Some signs of an opioid overdose include:

Person will not wake up and does not respond to your voice or touch

Breathing is very slow, irregular, or has stopped

Center part of their eye is very small, also known as “pinpoint pupils”

Take control of your safety. Talk to your doctor about your risk factors. Be ready with KLOXXADO®.

A bystander was present for nearly 40% of fatal overdoses.

Take action right away

Take action if you suspect an opioid overdose emergency, even if you’re not sure. It could save someone’s life.

Administer Naloxone

Naloxone is a life-saving medication that counters the effects of an opioid overdose.

Call 911

Explain that someone is not responsive and not breathing.

Stay With the Person

Help them feel more comfortable until emergency help arrives.

Give More Naloxone (if needed)

If a person doesn’t respond or responds then relapses into overdose symptoms, give additional doses of KLOXXADO® every 2-3 minutes until help arrives.

The Opioid Epidemic

With the spread of illegally-made, synthetic opioids like fentanyl, overdose deaths have grown across ages, races, ethnicities and communities.

Facts About Fentanyl

Facts About Fentanyl

Extremely potent, illegally-made synthetic opioids such as fentanyl and carfentanil are the most common drugs involved in overdose deaths in the United States.

How To Recognize An Opioid Overdose Emergency

Here’s what to look for and what to do if you suspect an opioid overdose emergency.

See More Resources ›

Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications

Hypersensitivity to naloxone hydrochloride or to any of the other ingredients

Warnings and Precautions

  • Use KLOXXADO® right away if you suspect an opioid overdose emergency, even if you are not sure, because an opioid overdose emergency can cause severe injury or death. Signs and symptoms of an opioid overdose emergency may include:
    • Unusual sleepiness; you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum).
    • Breathing problems, including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing.
    • The black circle in the center of the colored part of the eye (pupil) is very small (sometimes called “pinpoint pupils”) in someone difficult to awaken.
  • Family members, caregivers or other people who may have to use KLOXXADO® in an opioid overdose emergency should know where KLOXXADO® is stored and how to give KLOXXADO® before an opioid overdose emergency happens.
  • Get emergency medical help right away after using the first dose of KLOXXADO®. Rescue breathing or CPR (cardiopulmonary resuscitation) may be needed while waiting for emergency medical help.
  • The signs and symptoms of an opioid overdose emergency can return after KLOXXADO® is given. If this happens, give another dose after 2 to 3 minutes, using a new KLOXXADO® device, alternating nostrils, and watch the person closely until emergency medical help arrives.
  • Do not use KLOXXADO® if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO®.
  • KLOXXADO® can cause sudden and severe opioid withdrawal, the symptoms of which may include body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure.
  • In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.
  • Tell your doctor about all of your medical conditions before using KLOXXADO®, including if you have heart problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
  • Tell your doctor about all of the medicines you take, including prescription drugs and over-the-counter medicines, drugs, vitamins and herbal supplements.

Side Effects

The following serious side effect is discussed in the full Prescribing Information for KLOXXADO®:

  • Sudden and Severe Opioid Withdrawal

Symptoms of sudden and severe opioid withdrawal resulting from the use of KLOXXADO® in someone regularly using opioids include: body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure.

Infants may have seizures, cry more than normal and have increased reflexes.

Some people may become aggressive after abrupt reversal of opioid overdose.

In two clinical studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO®, one spray in one nostril. Side effects were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

These are not all of the possible side effects of KLOXXADO®. Contact your doctor for medical advice about side effects.

Pregnancy, Infancy and Breastfeeding, Children

Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant and opioid dependent, use of KLOXXADO® may cause withdrawal symptoms in you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO®.

There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production.

If the primary concern is an infant at risk of an overdose, consider whether other naloxone-containing products may be more appropriate.

KLOXXADO® nasal spray is safe and effective in children for known or suspected opioid overdose.

Dosage and Administration

Do not attempt to prime or test-fire the device. Each KLOXXADO® Nasal Spray contains only 1 dose of medicine and cannot be reused. Read the “instructions for use” at the end of the Prescribing Information and Medication Guide for detailed information about the right way to use KLOXXADO® Nasal Spray.

Storage and Handling

Store KLOXXADO® at room temperature between 68°F to 77°F (20°C to 25°C). Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C). Do not freeze KLOXXADO®. Keep KLOXXADO® in its box until ready to use. Protect from light. Replace KLOXXADO® before the expiration date on the box. Keep KLOXXADO® and all medicines out of the reach of children.

For more information, please see the full Prescribing Information and Medication Guide.

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

This website is intended for U.S. audiences
Customer Service: Phone 1-800-631-2174 | Email

© Hikma Pharmaceuticals USA Inc. All rights reserved.

KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
Better Health. Within Reach. Every Day.®️ is a registered trademark of Hikma Pharmaceuticals PLC.
Emergent Devices Inc. is wholly owned subsidiary of Emergent BioSolutions Inc.
KLOXXADO® is manufactured by Hikma Pharmaceuticals USA Inc. Columbus, OH 43228, and distributed by Emergent Devices Inc. Plymouth Meeting, PA 19462.

PP-KLOX-US-00029

July 2025

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Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications