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Exalgo Side Effects

Generic name: hydromorphone

Medically reviewed by Drugs.com. Last updated on Sep 15, 2023.

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

Applies to hydromorphone: injection solution. Other dosage forms:

Warning

Injection route (Solution)

Do not confuse HYDROmorphone hydrochloride Injection [high potency formulation (HPF)] with standard parenteral formulations of Hydromorphone Hydrochloride Injection or other opioids, as overdose and death could result.HYDROmorphone hydrochloride Injection and HYDROmorphone hydrochloride Injection [high potency formulation (HPF)] exposes users to risks of addictions, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.Prolonged use of HYDROmorphone hydrochloride Injection or HYDROmorphone hydrochloride Injection [high potency formulation (HPF)] during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Injection route (Solution)

HYDROmorphone hydrochloride injection exposes users to risks of addictions, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.Prolonged use of HYDROmorphone hydrochloride injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

Serious side effects of Exalgo

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 or nurse immediately if any of the following side effects occur while taking hydromorphone:

Incidence not known

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

Symptoms of overdose

Other side effects of Exalgo

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:

Incidence not known

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]

Frequently asked questions

References

1. Product Information. Dilaudid (hydromorphone). Knoll Pharmaceutical Company. 2001;PROD.

2. Multum Information Services, Inc. Expert Review Panel

3. Cerner Multum, Inc. UK Summary of Product Characteristics.

4. Cerner Multum, Inc. Australian Product Information.

5. Product Information. Exalgo (hydromorphone). Covidien. 2010.

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.