Hydrostat IR Side Effects

Generic name: hydromorphone

Medically reviewed by Drugs.com. Last updated on Oct 14, 2023.

Note: This document provides detailed information about Hydrostat IR Side Effects associated with hydromorphone. Some dosage forms listed on this page may not apply specifically to the brand name Hydrostat IR.

Applies to hydromorphone: injection solution.

Other dosage forms:

• oral solution, oral tablet, oral tablet extended release

Important warnings This medicine can cause some serious health issues

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 Hydrostat IR

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

• abdominal or stomach pain
• blurred vision
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• chest pain or discomfort
• cold, clammy skin
• confusion
• cough
• difficult or troubled breathing
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• irregular, fast, slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• loss of appetite
• noisy breathing
• pale or blue lips, fingernails, or skin
• severe constipation
• severe vomiting
• slow or irregular heartbeat
• sweating
• tightness in the chest
• trouble with sleeping
• unusual tiredness
• very slow heartbeat or pulse
• vomiting

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

Symptoms of overdose

• change in consciousness
• cold and clammy skin
• convulsions (seizures)
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pale or blue lips, fingernails, or skin
• pinpoint (small) pupils in the eyes
• sleepiness or unusual drowsiness
• slow heartbeat
• unable to speak
• very slow or troubled breathing
• weak muscle tone

Other side effects of Hydrostat IR

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

• anxiety
• bad, unusual, or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• chills
• constricted, pinpoint, or small pupils (black part of the eye)
• decrease in the frequency or amount of urination
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty in passing urine (dribbling)
• double vision
• dry mouth
• false or unusual sense of well-being
• fast or rapid breathing
• feeling of warmth
• hives or welts
• irritability
• itching
• loss of appetite
• muscle stiffness or tightness
• nausea
• painful urination
• redness, pain, or swelling at the injection site
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed or calm feeling
• seeing, hearing, or feeling things that are not there
• seeing double
• shaking
• sleepiness
• uncontrolled eye movements
• upper stomach pain
• weight loss

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 adverse events

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

• Uncommon (0.1% to 1%): Decreased libido, sexual dysfunction
• Rare (less than 0.1%): Hypogonadism

Opioids:

• Postmarketing reports: Adrenal insufficiency, androgen deficiency^[Ref]

Hydromorphone (the active ingredient contained in Hydrostat IR)

Frequently asked questions

• Which painkiller should you use?
• Oxymorphone vs Hydromorphone - How do they compare?

Further information

Hydrostat IR side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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