What Is Dilaudid?

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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. Dilaudid is available in generic form.

• Generic Name: hydromorphone hydrochloride
• Brand Name: Dilaudid

What Are Side Effects of Dilaudid?

Common side effects of Dilaudid include

• flushing (warmth,
• redness, or tingling of skin),
• itching,
• sweating,
• nausea,
• vomiting,
• constipation,
• diarrhea,
• stomach pain,
• dizziness,
• drowsiness,
• blurred vision,
• double vision,
• headache,
• sleep problems (insomnia),
• strange dreams, and
• dry mouth.

Serious side effects of Dilaudid include

• shallow, weak, or very slow breathing,
• trouble breathing,
• slow heart rate,
• confusion,
• lightheadedness or fainting,
• seizures (convulsions),
• cold clammy skin,
• pounding heartbeats or fluttering in your chest,
• wheezing,
• confusion,
• severe weakness or drowsiness,
• mental/mood changes (such as agitations, confusion, hallucinations),
• severe stomach or abdominal pain,
• difficulty urinating, or
• death.

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.

Dosage for Dilaudid

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.

What Drugs, Substances, or Supplements Interact with Dilaudid?

Dilaudid may interact with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, other medicines that can make you sleepy or slow your breathing, buprenorphine, butorphanol, nalbuphine, pentazocine, atropine, belladonna, benztropine, dimenhydrinate, methscopolamine, scopolamine, bladderor urinary medicines, bronchodilators, irritable bowel medicines, or ulcer medications. Tell your doctor all medications and supplements you use.

Dilaudid During Pregnancy and Breastfeeding

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.

Additional Information

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• confusion, feelings of extreme happiness or sadness;
• severe weakness or drowsiness;
• a light-headed feeling, like you might pass out;
• low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

• drowsiness, tiredness;
• dizziness;
• headache; or
• constipation, nausea, vomiting, stomach pain.

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.

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
• Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
• Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
• Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
• Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
• Severe Hypotension [see WARNINGS AND PRECAUTIONS]
• Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Serious adverse reactions associated with DILAUDID include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.

The most common adverse effects are lightheadedness, 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

Cardiac disorders: tachycardia, bradycardia, palpitations

Eye disorders: vision blurred, diplopia, miosis, visual impairment

Gastrointestinal disorders: constipation, ileus, diarrhea, abdominal pain

General disorders and administration site conditions: weakness, feeling abnormal, chills

Hepatobiliary disorders: biliary colic

Metabolism and nutrition disorders: decreased appetite

Musculoskeletal and connective tissue disorders: muscle rigidity

Nervous system disorders: headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration, involuntary muscle contractions, presyncope

Psychiatric disorders: agitation, mood altered, nervousness, anxiety, depression, hallucination, disorientation, insomnia, abnormal dreams

Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects

Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm

Skin and subcutaneous tissue disorders: urticaria, rash, hyperhidrosis

Vascular disorders: flushing, hypotension, hypertension

Postmarketing Experience

The following adverse reactions have been identified during post approval use of hydromorphone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Confusional state, convulsions, drowsiness, dyskinesia, dyspnea, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in DILAUDID Oral Solution or DILAUDID Tablets.