Naloxone Side Effects: Do’s and Don’ts

Other Naloxone side effects:
Gastrointestinal disorders: vomiting, nausea
Nervous system disorders: convulsions, paraesthesia, grand mal convulsion
Psychiatric disorders: agitation, hallucination, tremulousness
Respiratory, thoracic, and mediastinal disorders: dyspnea, respiratory depression, hypoxia
Skin and subcutaneous tissue disorders: nonspecific injection site reactions, sweating
Vascular disorders: hypertension, hypotension, hot flashes, or flushing

DO know that this isn’t a complete list of Naloxone side effects and others may occur. DO call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Important information
DO know that excessive doses of Naloxone in postoperative patients may result in significant reversal of analgesia and may cause agitation.
DO know that several instances of the following have been reported from Naloxone use in opioid overdose:
• high or low blood pressure (hypotension and hypertension). Patients with mild to moderate hypertension who receive Naloxone during labor should be carefully monitored as severe hypertension may occur.
• rapid or irregular heartbeat (ventricular tachycardia and fibrillation)
• blood clots in the lung (pulmonary edema)
• heart attack (cardiac arrest)

These have resulted to coma, encephalopathy or death.
Naloxone should be used with caution in patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects such as hypotension, ventricular tachycardia or fibrillation and pulmonary edema.

Studies have also suggested that naloxone is effective as an antidote to overdose but its mechanism of work causes blood clots to form in the lung when it triggers a centrally mediated massive catecholamine response. This leads to a dramatic shift of blood volume into the lungs and a rise in the lung’s fluid pressure.

DO know that there aren’t enough studies to know if geriatric patients respond differently than younger patients. But in general, elderly patient should start at the low end of the dosing range.

Kidney and liver problems
DO know that the safety of naloxone in patients with renal insufficiency/failure has not been established in well-controlled clinical trials. Caution should be exercised when Naloxone is administered to patients with kidney problems.
DO know that the safety and effectiveness of naloxone in patients with liver disease has not been established in well-controlled clinical trials. Caution should be exercised when Naloxone is administered to patients with liver disease.

Important information
DON’T use this Naloxone if you are allergic to it.
In an emergency, it’s unlikely that you’d be able to tell your doctor if you’re pregnant or breastfeeding. But afterward, DO make sure that your doctor knows that you have received Naloxone.
DO know that Naloxone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
DO know that if you are using any narcotic pain medication, the pain-relieving effects of the narcotic will be reversed while you are also receiving naloxone.
DO know that drinking alcohol can increase certain side effects of naloxone.

If possible, before you receive naloxone, DO tell your doctor if you have:
• heart disease
• seizures
• a history of head injury or brain tumor
• a history of drug or alcohol addiction

Allergic side effects
DO get emergency medical help if you have any of these signs of an allergic reaction: hives difficulty breathing swelling of your face, lips, tongue, or throat. Call your doctor at once, if you have a serious side effect such as:
• sweating, severe nausea or vomiting
• dry cough, wheezing, feeling short of breath
• feeling like you might pass out or
• severe headache, agitation, anxiety, confusion, ringing in your ears
• chest pain, fast or irregular heartbeats
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop)
• seizure (convulsions)

Use in pregnancy
The FDA groups Naloxone as pregnancy category C.
DO tell your doctor if you are pregnant or plan to become pregnant while using this medication. It isn’t known if naloxone will harm an unborn baby.
DON’T use this medication without telling your doctor if you are breast-feeding a baby.
It isn’t known whether naloxone passes into breast milk or if it could harm a nursing baby.

Missing a dose
Because you will receive naloxone in a clinical setting, you are not likely to miss a dose.

Overdose
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include seizure (convulsions), feeling light-headed, or fainting.

What to avoid while taking Naloxone
DO know that Naloxone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of naloxone.

Drug interactions
DO tell your doctor about all other medicines you use, especially:
buprenorphine (Buprenex, Subutex)
methohexital (Brevital) or
narcotic pain medication such as codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid, Palladone), oxycodone (OxyContin, Percocet), fentanyl (Actiq, Duragesic), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph), and many others.

This list isn’t complete and other drugs may interact with naloxone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. DON’T start a new medication without telling your doctor.