"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
Dilaudid Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Dilaudid (hydromorphone hydrochloride) and Dilaudid Injection (also termed Dilaudid HP) are the tablet, liquid and IV forms of an opioid analgesic used for control of moderate to severe pain. It is available as a generic named hydromorphone hydrochloride. Common side effects that may occur with both tablet and IV forms of Dilaudid are redness or tingling of skin, itching, sweating, nausea, vomiting, constipation, dizziness, headache, and mouth dryness. Note that these drug preparations have serious side effects listed below and are often abused by drug-seeking patients.
Dilaudid is available in tablets in 8 mg strength, in liquid form in 5 mg strength per 5 ml of liquid, and Dilaudid Injection is available as sterile solution containing 1, 2, or 4 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. Dosage of tablets usually begins at 2-4 mg every 4-6 hours; liquid begins at 2.5 mg (2.5 ml) every 3-6 hours and may be modified according to patient response and doctor's prescription. Dilaudid injection starting dose is 1-2 mg subcutaneously or intramuscularly every 4 to 6 hours as necessary for pain; it can also be given IV slowly over 2-3 min but respiration needs to be monitored. However, the drug preparations are designated schedule 2 opioid antagonists and have the highest potential for abuse and risk of respiratory depression. Use of Dilaudid with alcohol, sedative or hypnotic drugs or other opioid drugs may depress breathing enough to cause death. Serious side effects of Dilaudid are shallow or very slow breathing, bradycardia, confusion, syncope, seizures, cold clammy skin, and death. In addition, after a few weeks of use, patients may develop both tolerance and physical dependence on Dilaudid and may need to be slowly weaned off the drug to avoid withdrawal symptoms. Dilaudid should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus or breastfeeding infant; the drug should not be used for labor or delivery; pregnant women taking the medication will usually cause the fetus/infant to be dependent on opioids and likely will have other effects on the infant. There are no Dilaudid studies on pediatric patients.
Our Dilaudid and Dilaudid Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Dilaudid in Detail - Patient Information: Side Effects
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 any of these serious side effects:
- shallow breathing, slow heartbeat;
- seizure (convulsions);
- cold, clammy skin;
- severe weakness or dizziness; or
- feeling light-headed, fainting.
Less serious side effects are more likely to occur, such as:
- nausea, vomiting, constipation, loss of appetite;
- warmth, tingling, or redness under your skin;
- dizziness, headache;
- dry mouth;
- sweating; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Dilaudid (Hydromorphone Hydrochloride) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Dilaudid Overview - Patient Information: Side Effects
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.
Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Dilaudid (Hydromorphone Hydrochloride)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Dilaudid FDA Prescribing Information: Side Effects
The major hazards of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS include respiratory depression and apnea. To a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest have occurred.
The most frequently observed adverse effects are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.
Less Frequently Observed Adverse Reactions
General and CNS: Weakness, headache, agitation, tremor, uncoordinated muscle movements, alterations of mood (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia and miosis, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial pressure
Respiratory: Bronchospasm and laryngospasm
Genitourinary:Urinary retention or hesitancy, antidiuretic effects
Dermatologic: Urticaria, other skin rashes, diaphoresis.
Drug Abuse And Dependence
DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 MG TABLETS contain hydromorphone, a Schedule II controlled opioid agonist. Schedule II opioid substances which include morphine, oxycodone, oxymorphone, fentanyl, and methadone have the highest potential for abuse and risk of fatal overdose. Hydromorphone can be abused and is subject to criminal diversion.
Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued opioid usage, but it may occur after as little as a week of opioid use. Physical dependence and tolerance are separate and distinct from abuse and addiction.
Addiction is a chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
"Drug seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with, forging or counterfeiting prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers, people suffering from untreated addiction and criminals seeking drugs to sell.
Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS are intended for oral use only. Misuse or abuse of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS pose a risk of overdose and death. This risk is increased with concurrent abuse of alcohol and other CNS depressants. Parenteral drug abuse can potentially result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. In addition, parenteral abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Safety And Handling Instructions
DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS pose little risk of direct exposure to health care personnel and should be handled and disposed of prudently in accordance with hospital or institutional policy. Significant absorption from dermal exposure is unlikely; accidental dermal exposure to DILAUDID (hydromorphone hydrochloride) ORAL LIQUID should be treated by removal of any contaminated clothing and rinsing the affected area with cool water. Patients and their families should be instructed to flush any DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS that are no longer needed.
Access to abuseable drugs such as DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by health care providers.
Read the entire FDA prescribing information for Dilaudid (Hydromorphone Hydrochloride) »
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