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Embeda

"People who suffer chronic pain face a good news/bad news situation in choosing a treatment. There are powerful medicines called opioids that can help manage pain when prescribed for the right condition and when used properly. But when prescribed "...

Embeda

Embeda Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Embeda (morphine sulfate and naltrexone hydrochloride) is a combination of a narcotic pain reliever (morphine) and a special narcotic drug (naltrexone) that blocks the effects of other narcotic medicines and alcohol, used to treat moderate to severe pain when around-the-clock pain relief is needed for a long time period. Common side effects include drowsiness, dizziness, nausea, vomiting, constipation, lightheadedness, or headache.

The starting dose of Embeda is individualized, and patients are monitored closely for respiratory depression within the first 24-72 hours. Embeda may interact with other medications that can make you sleepy or slow your breathing (such as cold or allergy medicine, sedatives, narcotics, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety), pentazocine, nalbuphine, butorphanol, buprenorphine, diuretics, quinidine, atropine, belladonna, benztropine, dimenhydrinate, methscopolamine or scopolamine, bronchodilators, ulcer or irritable bowel medications, bladder or urinary medications, antibiotics, antifungals, heart or blood pressure medications, HIV/AIDS medications, or medicines used to prevent organ transplant rejection. Tell your doctor all medications and supplements you use. During pregnancy, this medication should be used only when prescribed. Tell your doctor if you are pregnant or if you plan to become pregnant. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Using it for a long time or near the expected delivery date may harm the fetus. Tell the doctor if you notice any symptoms in your newborn such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Embeda (morphine sulfate and naltrexone hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Embeda in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Embeda (Morphine Sulfate and Naltrexone Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Embeda Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Embeda (Morphine Sulfate and Naltrexone Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Embeda FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

In the randomized study, the most common adverse reactions with EMBEDA therapy were constipation, nausea, and somnolence. The most common adverse reactions leading to study discontinuation were nausea, constipation (sometimes severe), vomiting, fatigue, dizziness, pruritus, and somnolence.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Short-Term Randomized Study

This study utilized an enriched enrollment with a randomized withdrawal design in which subjects were titrated to effect on open-label EMBEDA for up to 45 days. Once their pain was controlled, 344 of 547 subjects were randomized to either an active treatment with EMBEDA or were tapered off EMBEDA using a double-dummy design and placed on placebo. The maintenance Period was 12 weeks. Adverse reactions, reported in ≥ 2% of subjects in either the titration or maintenance phase of the 12-week study are presented in Table 1.

Table 1: Adverse Reactions Reported in ≥ 2% of Subjects in the Randomized Study

Adverse Reaction Titration Maintenance
EMBEDA
(N=547)
n (%)
EMBEDA
(N=171)
n (%)
Placebo
(N=173)
n (%)
Constipation 165 (30%) 12 (7%) 7 (4%)
Nausea 106 (19%) 19 (11%) 11 (6%)
Somnolence 76 (14%) 2 (1%) 5 (3%)
Vomiting 46 (8%) 7 (4%) 2 (1%)
Dizziness 42 (8%) 2 (1%) 2 (1%)
Pruritus 34 (6%) 0 1 (1%)
Dry mouth 31 (6%) 3 (2%) 2 (1%)
Headache 22 (4%) 4 (2%) 2 (1%)
Fatigue 16 (3%) 1 (1%) 2 (1%)
Insomnia 7 (1%) 5 (3%) 4 (2%)
Diarrhea 6 (1%) 12 (7%) 12 (7%)
Abdominal pain upper 6 (1%) 4 (2%) 3 (2%)
Flushing 0 4 (2%) 1 (1%)

Long-Term Open-Label Safety Study

In the long-term open-label safety study, 465 patients with chronic non-malignant pain were enrolled and 124 patients were treated for up to 1 year. The distributions of adverse events were similar to that of the randomized, controlled studies, and were consistent with the most common opioid-related adverse reactions. Adverse reactions reported in > 2.0% of subjects are presented in Table 2.

Table 2: Adverse Reactions Reported by ≥ 2.0% of Subjects in Long-Term Safety Study

Adverse Reaction EMBEDA
(N=465)
n (%)
Constipation 145 (31%)
Nausea 103 (22%)
Vomiting 37 (8%)
Somnolence 34 (7%)
Headache 32 (7%)
Pruritus 26 (6%)
Fatigue 19 (4%)
Dizziness 19 (4%)
Dry mouth 17 (4%)
Hyperhidrosis 16 (3%)
Insomnia 13 (3%)
Diarrhea 10 (2%)
Anxiety 10 (2%)

Adverse Reactions Observed in the Phase 2/3 Studies

Most common ( ≥ 10%): constipation, nausea, somnolence

Common ( ≥ 1% to < 10%): vomiting, headache, dizziness, pruritus, dry mouth, diarrhea, fatigue, insomnia, hyperhidrosis, anxiety, chills, abdominal pain, lethargy, edema peripheral, dyspepsia, anorexia, muscle spasms, depression, flatulence, restlessness, decreased appetite, irritability, stomach discomfort, tremor, arthralgia, hot flush, sedation

Less Common ( < 1%):

Eye disorders: vision blurred, orthostatic hypotension

Gastrointestinal disorders: abdominal distension, pancreatitis, abdominal discomfort, fecaloma, abdominal pain lower, abdominal tenderness

General disorders and administration site conditions: malaise, asthenia, feeling jittery, drug withdrawal syndrome

Hepatobiliary disorders: cholecystitis

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased

Musculoskeletal and connective tissue disorders: myalgia, muscular weakness

Nervous system disorders: depressed level of consciousness, mental impairment, memory impairment, disturbance in attention, stupor, paresthesia, coordination abnormal

Psychiatric disorders: disorientation, thinking abnormal, mental status changes, confusional state, euphoric mood, hallucination, abnormal dreams, mood swings, nervousness

Renal and urinary disorders: urinary retention, dysuria

Reproductive system and breast disorders: erectile dysfunction

Respiratory, thoracic and mediastinal disorders: dyspnea, rhinorrhea

Skin and subcutaneous tissue disorders: rash, piloerection, cold sweat, night sweats

Vascular disorders: hypotension, flushing

Anaphylaxis has been reported with ingredients contained in EMBEDA. Advise patients how to recognize such a reaction and when to seek medical attention.

Read the entire FDA prescribing information for Embeda (Morphine Sulfate and Naltrexone Hydrochloride) »

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Embeda - User Reviews

Embeda User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Embeda sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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