Hydromorphone (Dilaudid) Warnings, Risks, and Complications

RISK OF ACCIDENTAL OVERDOSE: Taking too much hydromorphone can result in overdose and death. Make sure you understand the dosing instructions. Ask your doctor if you’re not sure how to take this medicine. 

Even one tablet of hydromorphone can result in an overdose in a child. Opioid overdoses can result in death if they are not recognized and treated in time. The risk of overdose is higher if you take the medicine at higher doses or more frequent doses than prescribed. 

A hydromorphone overdose is a medical emergency. You should seek emergency medical attention without delay. Symptoms of an overdose may include slowed breathing, slowed heartbeat, unusual tiredness, extreme drowsiness, sweating, cold and clammy skin, limp muscles, constricted pupils, bluish tinge to the lips and fingertips, and unresponsiveness. 

Talk to your doctor or pharmacist about having a rescue due called naloxone (Narcan) available to reverse the effects of an opioid overdose.

If you are taking liquid hydromorphone, use a calibrated dose-measuring cup or syringe to measure the dose accurately. Do not use a household spoon, as this can result in an overdose.

OPIOID MISUSE, ABUSE, AND ADDICTION: Hydromorphone is habit-forming. Taking this medicine, even at the prescribed doses, can lead to misuse, abuse, and opioid addiction. The risk is greater in people with a personal or family history of alcohol or substance use disorder or other mental health conditions such as major depression. Your doctor will prescribe the lowest dose of hydromorphone for the shortest possible time to treat your pain. Do not take hydromorphone at higher doses or more frequent doses than prescribed. Misuse and abuse of this medication can lead to serious complications, including overdose and death. 

 Hydromorphone is in the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) program. This program is designed to lower the risk of misuse, abuse, addiction, and overdose from narcotic medications. You can only fill your hydromorphone prescription at certified pharmacies. Healthcare providers who prescribe hydromorphone must undergo special education and training. Your doctor or pharmacist will give you a Medication Guide and discuss the proper use, risks, storage, and disposal of hydromorphone with you. Read this information carefully and make sure you understand it.

LIFE-THREATENING RESPIRATORY DEPRESSION: Taking hydromorphone can lead to serious breathing problems, including slowed or stopped breathing and death, even when you take the medicine at prescribed doses. This risk is highest in the first 24-72 hours of starting hydromorphone and after a dose increase. Children and elderly individuals (age 65 years and older) and those with severe bronchial asthma, other lung conditions, sleep apnea, or sleep-related hypoxemia are at a greater risk of breathing complications. Taking other medications that can also slow down breathing, such as certain muscle relaxants, benzodiazepines, sedatives, alcohol, and other CNS depressants, may also lead to respiratory depression.

NEONATAL OPIOID WITHDRAWAL SYNDROME: Using hydromorphone during pregnancy can lead to opioid dependence in the unborn baby. After birth, the baby can experience withdrawal effects with symptoms such as high-pitched crying, poor feeding, irritability, sleep difficulties, shakiness, and seizures. Neonatal opioid withdrawal syndrome can be life-threatening if it is not diagnosed and treated in time. Observe your baby carefully for opioid withdrawal symptoms if you took hydromorphone during the pregnancy. Seek medical help if they occur.

RISKS WITH OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS: Taking hydromorphone with certain medications that are also CNS depressants, for example, sedatives, hypnotics, tranquilizers, benzodiazepines, muscle relaxants, antipsychotics, other opioids, and alcohol, can lead to slowing of brain activity, slowed breathing, severe sleepiness, coma, and even death. 

Give your healthcare professional a complete list of your current medications. Take hydromorphone at the lowest dose for the shortest time to relieve pain. Be careful while driving or doing other activities that require focus. Tell your health care provider if you have a history of alcohol or substance abuse. Seek emergency medical attention if you experience any of the above-mentioned symptoms. The risk of CNS depression and respiratory depression is higher in older adults (age 65 plus), debilitated and cachectic patients, patients with chronic lung conditions, and those taking higher doses of hydromorphone.

ADRENAL INSUFFICIENCY: Use of hydromorphone (usually for more than 1 month) can lead to adrenal insufficiency (low levels of a hormone called cortisol produced by the adrenal glands in the body). This hormone helps to regulate mood, stress levels, blood pressure, and blood sugar. Tell your doctor right away if you develop symptoms such as nausea, vomiting, loss of appetite, dizziness, weakness, unusual tiredness, or decreased blood pressure. Your healthcare professional may prescribe corticosteroid medications or switch you from opioid medications to non-opioid medications to relieve pain.

SEVERE HYPOTENSION: Hydromorphone can cause a severe drop in blood pressure. This can lead to lightheadedness and fainting, especially when changing positions from sitting or lying to standing. Older adults (age 65 and above), those taking other medications that can also cause low blood pressure, and people taking antipsychotics called phenothiazines are at an increased risk of hypotension. Blood pressure changes are also more likely if you are dehydrated and after your hydromorphone dose is adjusted. Get up slowly from a lying or sitting position to avoid falls. Tell your doctor if these symptoms persist after a few days.

RISK IN PEOPLE WITH A HEAD INJURY, BRAIN TUMOR OR IMPAIRED CONSCIOUSNESS: Treatment with hydromorphone can reduce the respiratory drive and lead to intracranial carbon dioxide retention. This can be dangerous in people with elevated intracranial pressure, such as those with a brain tumor or head injury. Hydromorphone is generally avoided in people who have impaired consciousness or are in a coma.

RISK IN PEOPLE WITH GASTROINTESTINAL CONDITIONS: Hydromorphone is contraindicated in people with known or suspected obstructions in the gastrointestinal tract, including paralytic ileus. Before starting hydromorphone, tell your doctor if you have a history of gastrointestinal conditions, including increased liver enzymes, biliary tract disease, or pancreatitis. Call your doctor if you have worsening gastrointestinal symptoms after taking this medicine.

RISK IN PEOPLE WITH SEIZURE DISORDERS: Hydromorphone can increase seizure frequency in people with seizure disorders. If you have a history of seizures, your doctor will monitor you carefully for any worsening after starting hydromorphone therapy.

WITHDRAWAL EFFECTS: Do not stop taking hydromorphone suddenly after taking this medicine for a period of time. Your doctor will tell you how to gradually lower the dose. Rapidly lowering the dose or stopping the medicine abruptly can lead to a withdrawal syndrome and return of pain. Your doctor will also tell you to avoid using other types of pain medications, such as mixed agonists/antagonists (for example, nalbuphine, pentazocine, and butorphanol) or partial agonists (for example, buprenorphine) when you are receiving a full opioid agonist such as hydromorphone. Taking these other pain medicines can reduce the pain-relieving effect of hydromorphone and cause withdrawal effects.

RISKS WHILE DRIVING AND OPERATING MACHINERY: Hydromorphone can cause dizziness, drowsiness, and impaired mental and physical abilities. Be careful when performing potentially hazardous activities, such as driving a motor vehicle or operating machinery, until you know how you react to this medication.

SULFITE ALLERGY: Hydromorphone formulations contain sodium metabisulfite. People with a sulfite allergy can develop allergic reactions, including asthma episodes or even anaphylaxis (throat closing). Tell your doctor if you have asthma or a sulfite allergy.