Morphine / naltrexone Side Effects

Some side effects of morphine / naltrexone 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 morphine / naltrexone: oral capsule extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking morphine / naltrexone: hives; difficult breathing; chest pain, anxiety, pounding heartbeats, fainting; swelling of your face, lips, tongue, or throat.

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

• mood changes, hallucinations, confusion, unusual thoughts or behavior;

• weak or shallow breathing, feeling like you might pass out;

• cold and clammy skin, blue lips or skin;

• painful or difficult urination;

• severe constipation or stomach pain; or

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects of morphine / naltrexone may include:

• drowsiness, dizziness, anxiety, feeling tired;

• dry mouth, nausea, vomiting, mild constipation, diarrhea;

• blurred vision, headache;

• sleep problems (insomnia); or

• itching, sweating, or flushing (warmth, redness, or tingly feeling).

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 morphine / naltrexone: oral capsule extended release

Gastrointestinal

Gastrointestinal side effects including constipation (up to 31.2%), nausea (up to 22.2%), vomiting (up to 8.4%), diarrhea (up to 7%), dry mouth (up to 5.7%), upper abdominal pain (up to 2.3%), dyspepsia, flatulence, stomach discomfort, abdominal distension, pancreatitis, abdominal discomfort, fecaloma, lower abdominal pain, and abdominal tenderness have been reported.

Nervous system

Nervous system side effects including somnolence (up to 13.9%), dizziness (up to 7.7%), headache (up to 6.9%), lethargy, sedation, tremor, depressed level of consciousness, mental impairment, memory impairment, disturbance in attention, stupor, paraesthesia, and abnormal coordination have been reported.

Dermatologic

Dermatologic side effects including pruritus (up to 6.2%), hyperhidrosis (up to 3.4%), rash, piloerection, cold sweat, and night sweats have been reported.

General

General side effects including fatigue (up to 4.1%), chills, peripheral edema, irritability, malaise, asthenia, jittery feeling, and drug withdrawal syndrome have been reported.

Psychiatric

Psychiatric side effects including insomnia (2.9%), anxiety (up to 2.2%), depression, restlessness, disorientation, abnormal thinking, mental status changes, confusional state, euphoric mood, hallucination, abnormal dreams, mood swings, and nervousness have been reported.

Cardiovascular

Cardiovascular side effects including flushing (up to 2.3%), hot flush, and hypotension have been reported.

Metabolic

Metabolic side effects including anorexia and decreased appetite have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia, muscle spasms, myalgia, and muscular weakness have been reported.

Ocular

Ocular side effects including blurred vision have been reported.

Hepatic

Hepatic side effects including increased ALT and increased AST have been reported.

Renal

Renal side effects including urinary retention and dysuria have been reported.

Genitourinary

Genitourinary side effects including erectile dysfunction have been reported.

Respiratory

Respiratory side effects including dyspnea and rhinorrhea have been reported.

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