Arymo ER
- Generic Name: morphine sulfate extended-release tablets
- Brand Name: Arymo ER
Arymo ER(Morphine Sulfate Extended-release Tablets) side effects drug center
Arymo ER Side Effects Center
Arymo ER (morphine sulfate) extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Common side effects of Arymo ER include:
A single dose of Arymo ER greater than 60 mg, or a total daily dose greater than 120 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Arymo ER may interact with benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system, monoamine oxidase (MAO) inhibitors, butorphanol, nalbuphine, pentazocine, buprenorphine, muscle relaxants, cimetidine, diuretics, anticholinergic drugs, and quinidine. Tell your doctor all medications and supplements you use. Arymo ER is not recommended for use during pregnancy; it may harm a fetus. Prolonged use of opioid analgesics such as Arymo ER during pregnancy can cause neonatal opioid withdrawal syndrome. Arymo ER passes into breast milk and may cause adverse reactions in a nursing infant. Breastfeeding while using Arymo ER is not recommended. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Arymo ER.
Our Arymo ER (morphine sulfate) extended-release tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Arymo ER Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- slow heart rate, sighing, weak or shallow breathing, breathing that stops;
- chest pain, fast or pounding heartbeats;
- extreme drowsiness, feeling like you might pass out;
- serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or
- low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects may include:
- drowsiness, dizziness, tiredness;
- constipation, stomach pain, nausea, vomiting;
- sweating; or
- feelings of extreme happiness or sadness.
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 Arymo ER (Morphine Sulfate Extended-release Tablets)
Arymo ER Professional Information
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepines and Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ARYMO ER may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see OVERDOSAGE].
Most Frequently Observed Reactions
In clinical trials, the most common adverse reactions with morphine sulfate extended-release formulations were constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoric mood.
Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.
Less Frequently Observed Reactions
Cardiovascular disorders: tachycardia, bradycardia, palpitations
Eye disorders: visual impairment, vision blurred, diplopia, miosis
Gastrointestinal disorders: dry mouth, diarrhea, abdominal pain, constipation, dyspepsia
General disorders and administration site conditions: chills, feeling abnormal, edema, edema peripheral, weakness
Hepatobiliary disorders: biliary colic
Metabolism and nutrition disorders: anorexia
Musculoskeletal and connective tissue disorders: muscle rigidity, muscle twitching
Nervous system disorders: presyncope, syncope, headache, tremor, uncoordinated muscle movements, convulsion, intracranial pressure increased, taste alteration, paresthesia, nystagmus
Psychiatric disorders: agitation, mood altered, anxiety, depression, abnormal dreams, hallucination, disorientation, insomnia
Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effect
Reproductive system and breast disorders: reduced libido and/or potency
Respiratory, thoracic and mediastinal disorders: laryngospasm
Skin and subcutaneous tissue disorders: pruritus, urticaria, rash
Vascular disorders: flushing, hypotension, hypertension
Post-Marketing Experience
The following adverse reactions have been identified during postapproval use of morphine sulfate extended-release formulations. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events include: amenorrhea, asthenia, bronchospasm, confusional state, drug hypersensitivity, fatigue, hyperalgesia, hypertonia, ileus, increased hepatic enzymes, intestinal obstruction, lethargy, malaise, pulmonary edema, thinking disturbances, somnolence, and vertigo.
Serotonin Syndrome
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal Insufficiency
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis
Anaphylaxis has been reported with ingredients contained in ARYMO ER.
Androgen Deficiency
Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Arymo ER (Morphine Sulfate Extended-release Tablets)
&Copy; Arymo ER Patient Information is supplied by Cerner Multum, Inc. and Arymo ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.