Dilaudid Side Effects

Generic Name: hydromorphone

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.

For the Consumer

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

Other dosage forms:

Warning Oral route (Solution; Tablet) Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering HYDROmorphone oral solution. Dosing errors due to confusion between mg and mL can result in accidental overdose and death.Addiction, Abuse, and MisuseHYDROmorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing HYDROmorphone, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of HYDROmorphone. Monitor for respiratory depression, especially during initiation of HYDROmorphone or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of HYDROmorphone, especially by children, can result in a fatal overdose of HYDROmorphone.Neonatal Opioid Withdrawal SyndromeProlonged use of HYDROmorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of HYDROmorphone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. Oral route (Tablet, Extended Release) Addiction, Abuse, and MisuseHYDROmorphone hydrochloride exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing HYDROmorphone hydrochloride, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of HYDROmorphone hydrochloride. Monitor for respiratory depression, especially during initiation of HYDROmorphone hydrochloride or following a dose increase. Instruct patients to swallow HYDROmorphone hydrochloride extended-release tablets whole; crushing, chewing, or dissolving HYDROmorphone hydrochloride can cause rapid release and absorption of a potentially fatal dose of HYDROmorphone.Accidental IngestionAccidental ingestion of even one dose of HYDROmorphone hydrochloride, especially by children, can result in a fatal overdose of HYDROmorphone.Neonatal Opioid Withdrawal SyndromeProlonged use of HYDROmorphone hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of HYDROmorphone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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

For Healthcare Professionals

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

General

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

Gastrointestinal

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[Ref]

Nervous system

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)[Ref]

Psychiatric

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[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reactions, hypersensitivity reactions[Ref]

Respiratory

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[Ref]

Cardiovascular

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[Ref]

Dermatologic

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

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

Frequency not reported: Erythema

Postmarketing reports: Angioedema[Ref]

Local

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

Postmarketing reports: Injection site reactions[Ref]

Genitourinary

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

Postmarketing reports: Erectile dysfunction[Ref]

Hepatic

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

Rare (less than 0.1%): Biliary colic

Postmarketing reports: Hepatic enzyme increased[Ref]

Other

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[Ref]

Metabolic

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

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

Musculoskeletal

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

Uncommon (0.1% to 1%): Muscle rigidity

Frequency not reported: Myalgia[Ref]

Ocular

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

Frequency not reported: Dry eye[Ref]

Renal

Uncommon (0.1% to 1%): Antidiuretic effects[Ref]

Endocrine

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[Ref]

References 1. "Product Information. Dilaudid (hydromorphone)." Knoll Pharmaceutical Company, Whippany, NJ. 2. "Product Information. Exalgo (hydromorphone)." Covidien, Mansfield, MA. 3. "Multum Information Services, Inc. Expert Review Panel" 4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 5. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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