Dilaudid

Note: This document contains side effect information about hydromorphone. Some of the dosage forms listed on this page may not apply to the brand name Dilaudid.

Applies to hydromorphone: oral solution, oral tablet, oral tablet extended release

Other dosage forms:

• injection solution

Along with its needed effects, hydromorphone (the active ingredient contained in Dilaudid) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking hydromorphone:

Less common

• Agitation
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody, black, or tarry stools
• blurred vision
• changes in behavior
• chest pain or discomfort
• decreased urination
• dry mouth
• fast, pounding, slow, or irregular heartbeat
• lightheadedness, dizziness, or fainting
• mood or mental changes
• rapid breathing
• severe stomach pain, cramping, or burning
• stiff neck
• sunken eyes
• thoughts of killing oneself
• trouble breathing
• unusual tiredness
• vomiting of material that looks like coffee grounds, severe and continuing
• wrinkled skin

Incidence not known

• Bluish lips or skin
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• confusion
• constricted, pinpoint, or small pupils (black part of the eye)
• cough
• decrease in frequency of urination or urine amount
• deep or fast breathing with dizziness
• difficulty in passing urine (dribbling)
• dizziness
• fast or weak pulse
• headache
• hives or welts, itching, skin rash
• irregular, fast or slow, or shallow breathing
• loss of appetite
• noisy breathing
• overactive reflexes
• painful urination
• pale or blue lips, fingernails, or skin
• poor coordination
• restlessness
• sweating
• talking or acting with excitement you cannot control
• tightness in the chest
• trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur while taking hydromorphone:

Symptoms of overdose

• Cold, clammy skin
• convulsions (seizures)
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pinpoint (small) pupils in the eyes
• slow heartbeat
• very slow or troubled breathing

Some side effects of hydromorphone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty having a bowel movement
• difficulty with moving
• joint pain
• muscle pain or stiffness
• nausea

Less common

• Back pain
• belching
• diarrhea
• discouragement
• feeling sad or empty
• heartburn
• indigestion
• irritability
• loss of interest or pleasure
• muscle spasms
• pain in the arms or legs
• stomach discomfort, upset, or pain
• tingling of the hands or feet
• trouble concentrating
• unusual weight gain or loss

Less common

• Being forgetful
• bleeding after defecation
• clumsiness
• continuing ringing or buzzing or other unexplained noise in the ears
• crying
• delusions of persecution, mistrust, suspiciousness, or combativeness
• difficulty with swallowing
• difficulty with walking
• double vision
• excess air or gas in the stomach or bowels
• feeling of constant movement of self or surroundings
• full feeling
• increased appetite
• joint pain, stiffness, or swelling
• loss in sexual ability, desire, drive, or performance
• loss of balance
• low body temperature
• muscle aches
• muscle twitching or jerking
• rhythmic movement of muscles
• runny nose
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• shivering
• slurred speech
• sneezing
• trouble with speaking

Incidence not known

• Bad, unusual or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• drowsiness
• dry mouth
• false or unusual sense of well-being
• fear or nervousness
• feeling of warmth
• muscle stiffness or tightness
• numbness of the feet, hands, and around the mouth
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm feeling
• shaking
• uncontrolled eye movements
• upper stomach pain

Applies to hydromorphone: compounding powder, injectable powder for injection, injectable solution, intravenous solution, oral capsule extended release, oral liquid, oral tablet, oral tablet extended release, rectal suppository

The most common adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

Very common (10% or more): Constipation (up to 31%), nausea (up to 28%), vomiting (up to 14%),

Common (1% to 10%): Dry mouth, dry mouth, abdominal pain, diarrhea, dyspepsia

Uncommon (0.1% to 1%): Ileus, cramps, taste alteration, gastritis, diverticulitis

Rare (less than 0.1%): Anal fissure, bezoar, duodenitis, impaired gastric emptying, painful defecation

Frequency not reported: Flatulence, dysphagia, hematochezia, abdominal distension, hemorrhoids, abnormal feces, intestinal obstruction, eructation, diverticulum, gastrointestinal motility disorder, large intestine perforation

Postmarketing reports: Oropharyngeal swelling

Very common (10% or more): Somnolence (up to 15%), headache (up to 12%), dizziness (up to 11%)

Common (1% to 10%): Lightheadedness, sedation, memory impairment, hypoesthesia, paresthesia

Uncommon (0.1% to 1%): Tremor, nystagmus, increased intracranial pressure, taste alteration, involuntary muscle contractions

Rare (less than 0.1%): Hyperreflexia

Frequency not reported: Balance disorder, encephalopathy

Postmarketing reports: Convulsions, drowsiness, dyskinesia, hyperalgesia, myoclonus, serotonin syndrome (with concomitant serotonergic drugs)

Common (1% to 10%): Dysphoria, euphoria, insomnia, anxiety, depression, nervousness, nightmares, mood swings

Uncommon (0.1% to 1%): Agitation, altered mood, hallucination, disorientation, abnormal dreams

Frequency not reported: Floating feelings, dreams, apprehension, panic attack, suicide ideation, aggression

Postmarketing reports: Confusional state

Postmarketing reports: Anaphylactic reactions, hypersensitivity reactions

Common (1% to 10%): Dyspnea

Uncommon (0.1% to 1%): Bronchospasm, laryngospasm

Frequency not reported: Respiratory depression, apnea, respiratory arrest, rhinorrhea, respiratory distress, hypoxia, sneezing, hyperventilation

Postmarketing reports: Dyspnea

Common (1% to 10%): Flushing, hypotension, peripheral edema, chest pain

Uncommon (0.1% to 1%): Tachycardia, bradycardia, palpitations, syncope, presyncope, hypertension

Frequency not reported: Circulatory depression, cardiac arrest, shock, extrasystoles

Postmarketing reports: Peripheral edema

Common (1% to 10%): Sweating, pruritus, hyperhidrosis, rash

Uncommon (0.1% to 1%): Urticaria, diaphoresis

Frequency not reported: Erythema

Postmarketing reports: Angioedema

Uncommon (0.1% to 1%): Injection site urticaria

Postmarketing reports: Injection site reactions

Common (1% to 10%): Urinary retention, urinary hesitancy

Postmarketing reports: Erectile dysfunction

Uncommon (0.1% to 1%): Biliary tract spasm

Rare (less than 0.1%): Biliary colic

Postmarketing reports: Hepatic enzyme increased

Common (1% to 10%): Asthenia (up to 11%), pain, pyrexia, fall

Uncommon (0.1% to 1%): Weakness, abnormal feeling, chills

Rare (less than 0.1%): Feeling drunk

Frequency not reported: Neonatal withdrawal syndrome, addiction, abuse, misuse, overdose, drug withdrawal syndrome, vertigo, tinnitus, malaise

Postmarketing reports: Fatigue, lethargy

Common (1% to 10%): Anorexia/decreased appetite, decreased weight, dehydration

Uncommon (0.1% to 1%): Fluid retention, increased appetite, hyperuricemia

Common (1% to 10%): Arthralgia, muscle spasms, back pain, extremity pain

Uncommon (0.1% to 1%): Muscle rigidity

Frequency not reported: Myalgia

Uncommon (0.1% to 1%): Blurred vision, diplopia, miosis, visual impairment

Frequency not reported: Dry eye

Uncommon (0.1% to 1%): Antidiuretic effects

Hydromorphone (the active ingredient contained in Dilaudid)

Uncommon (0.1% to 1%): Decreased libido, sexual dysfunction

Rare (less than 0.1%): Hypogonadism

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency