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Exalgo 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 Exalgo.

For the Consumer

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

Other dosage forms:

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 .

Along with its needed effects, hydromorphone (the active ingredient contained in Exalgo) 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

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 Exalgo)

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. "Multum Information Services, Inc. Expert Review Panel"

3. "Product Information. Exalgo (hydromorphone)." Covidien, Mansfield, MA.

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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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