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Hydrostat IR 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 Hydrostat IR.

For the Consumer

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

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

Less common or rare
  • Agitation
  • bloody, black, or tarry stools
  • blurred vision
  • changes in behavior
  • chest pain or discomfort
  • convulsions
  • 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
  • cough
  • decrease in frequency of urination or urine amount
  • difficulty in passing urine (dribbling)
  • dizziness
  • fast or weak pulse
  • headache
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • noisy breathing
  • painful urination
  • pale or blue lips, fingernails, or skin
  • sweating
  • 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 (stool)
  • difficulty with moving
  • joint pain
  • muscle pain or stiffness
  • nausea
Less common
  • Acid or sour stomach
  • back pain
  • belching
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • 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 or rare
  • 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 intestines
  • 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
  • overactive reflexes
  • rhythmic movement of muscles
  • runny nose
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • shivering
  • slurred speech
  • sneezing
  • swelling of the feet or lower legs
  • trouble with speaking
Incidence not known
  • Bad, unusual or unpleasant (after) taste
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chills
  • constricted, pinpoint, or small pupils (black part of the eye)
  • deep or fast breathing with dizziness
  • drowsiness
  • dry mouth
  • false or unusual sense of well-being
  • fear or nervousness
  • feeling of warmth
  • hives or welts
  • itching
  • 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[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,[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. "UK Summary of Product Characteristics." O 0

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

Some side effects of Hydrostat IR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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