Palladone 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 Palladone.

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

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking hydromorphone (the active ingredient contained in Palladone) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• weak or shallow breathing;

• pounding heartbeats or fluttering in your chest;

• wheezing, chest tightness, trouble breathing;

• seizure (convulsions);

• confusion, severe weakness or drowsiness; or

• feeling like you might pass out.

Less serious side effects are more likely to occur, such as:

• blurred vision, double vision;

• flushing (warmth, redness, or tingly feeling);

• nausea, vomiting, constipation, diarrhea, stomach pain;

• dizziness, drowsiness;

• dry mouth;

• sweating;

• itching; or

• sleep problems (insomnia), or strange dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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

Nervous system

Nervous system side effects have included mental depression, respiratory depression (which is sometimes fatal), stupor, delirium, somnolence, agitation, increased intracranial pressure, and dysphoria. Myoclonus has also been reported.

Opioids may result in psychotic symptoms in some patients.

Other

Other side effects have included withdrawal symptoms which have occurred following either abrupt cessation or fast tapering of narcotic analgesics and have included agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.

Cardiovascular

Cardiovascular side effects have occurred rarely and have included hypotension, shock, and arrhythmias.

Gastrointestinal

Gastrointestinal side effects have included constipation, nausea, vomiting, biliary tract spasm, and dry mouth.

Dermatologic

Dermatologic side effects including rashes and systemic contact dermatitis have been reported rarely.

Narcotic-induced rashes may be related to direct stimulation of histamine release.

Local

Local side effects have included redness, swelling and pain which develop at the site of subcutaneous injection of hydromorphone (the active ingredient contained in Palladone) Two cases of fatal neurologic events have been reported following intravenous injection of hydromorphone. In one case, a known intravenous drug abuser injected two melted hydromorphone suppositories into the right antecubital vein and suffered a stroke. In the other, a known intravenous drug abuser injected ground hydromorphone tablets and presented in an akinetic mute state and later died.

Genitourinary

Genitourinary side effects including urinary retention have been reported for other narcotic analgesics.

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