Infumorph Side Effects Center

Last updated on RxList: 3/1/2022
Infumorph Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Infumorph?

Infumorph (morphine sulfate injection) is a narcotic pain reliever indicated only for intrathecal or epidural infusion in the treatment of intractable chronic pain.

What Are Side Effects of Infumorph?

Common side effects of Infumorph include:

  • itching
  • difficulty urinating/lessened urine production
  • constipation
  • headache
  • swelling of the extremities
  • dizziness
  • euphoria
  • anxiety
  • weak cough reflex
  • difficulty maintaining body temperature
  • hives
  • local injection site irritation
  • nausea, or
  • vomiting

Dosage for Infumorph

The starting dose of Infumorph must be individualized, based upon in hospital evaluation of the response to serial single-dose intrathecal bolus injections of regular Duramorph (morphine sulfate injection) 0.5 mg/mL or 1 mg/mL, with close observation of the analgesic efficacy and adverse effects prior to surgery involving the continuous microinfusion device.

What Drugs, Substances, or Supplements Interact with Infumorph?

Infumorph may interact with other drugs. Tell your doctor all medications and supplements you use.

Infumorph During Pregnancy and Breastfeeding

Infumorph should only be given to pregnant women when no other method of controlling pain is available and means are at hand to manage the delivery and perinatal care of the opiate-dependent infant. Infumorph passes into breast milk. Effects on a nursing infant are unknown. Consult your doctor before breastfeeding. Withdrawal effects may occur if you suddenly stop taking Infumorph.

Additional Information

Our Infumorph (morphine sulfate injection) 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.

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Infumorph 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 give naloxone and/or 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, shallow breathing, breathing that stops;
  • extreme drowsiness, feeling like you might pass out;
  • flushing (sudden warmth, redness, or tingly feeling);
  • a seizure;
  • high levels of serotonin in the body--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:

  • breathing problems;
  • drowsiness, dizziness;
  • constipation, nausea, vomiting;
  • sweating; or
  • numbness, tingling, or cold feeling in your hands and feet.

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 Infumorph (Morphine Sulfate Preservative-free Sterile Solution)

QUESTION

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Infumorph Professional Information

SIDE EFFECTS

Serious adverse drug reactions (ADRs) observed in patients receiving ALPHANATE include anaphylaxis/hypersensitivity reactions. Thromboembolic events also have been observed in patients receiving ALPHANATE for VWD [see WARNINGS AND PRECAUTIONS].

Clinical Trial Experience

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

Hemophilia A

In a prospective clinical study with ALPHANATE, 23 subjects were exposed to 1217 infusions (median=42, range 2-160). The total number of exposure days was 1133, and the total number of months on study across all subjects was 234 (19.5 subject years). No ADRs or inhibitors to FVIII were reported during the study.

von Willebrand Disease

In the prospective clinical study of ALPHANATE[using both ALPHANATE Solvent Detergent (A-SD, a previous generation product) and ALPHANATE Solvent Detergent/Heat Treated (A-SD/HT, the current generation product)] in subjects with von Willebrand Disease, ADRs occurred in 5 of 36 subjects (13.9%) treated with ALPHANATE.

Sixty-one total ADRs were reported in 204 infusions. The majority of ADRs were rated as mild (55 of 61 [90.2%]). Six ADRs (9.8%) were rated as moderate. No reactions rated as serious were reported. The adverse drug reaction grading scale is defined as follows:

  • Mild: the event was noted but the administration of the compound was not interrupted; the event resolved spontaneously or no treatment was required beyond administration of nonprescription analgesics.
  • Moderate: the administration of the compound was not necessarily interrupted; the event required momentary treatment with prescription drugs and produced no sequelae.

Overall, the proportion of infusions associated with ADRs was 14 of 204 infusions (6.9%).

The most common ADRs reported (> 1% of infusions) were pruritus, headache, backpain, paresthesia, respiratory distress, facial edema, pain, rash, and chills.

One incident of pulmonary embolism was reported that was considered to have a possible relationship to the product. This subject received a dose of 60 IU VWF:RCo/kg body weight and the FVIII:C level achieved was 290%.

In the retrospective study conducted to determine the efficacy and safety of ALPHANATE (A-SD/HT) in a surgical or invasive procedure setting as perioperative prophylaxis against excessive bleeding, [see Clinical Studies], 3 out of 39 subjects (7.7%) experienced 6 adverse drug reactions. Four were considered mild and 2 were considered moderate. No subject discontinued their treatment due to an adverse drug reaction. The adverse drug reactions were pruritus, paresthesia (2 events) and hemorrhage (all considered mild), and one event each of moderate hematocrit decrease and orthostatic hypotension.

One adverse drug reaction (pain) related to the treatment with heat-treated ALPHANATE (A-SD/HT) was reported in the four pediatric subjects with von Willebrand Disease during the course of the prospective study and in none of the five pediatric subjects in the retrospective clinical study.

Post-Marketing Experience

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.

The most common post-marketing ADRs reported include allergic/hypersensitivity reactions, nausea, fever, joint pain, fatigue, and infusion site pain.

Read the entire FDA prescribing information for Infumorph (Morphine Sulfate Preservative-free Sterile Solution)

© Infumorph Patient Information is supplied by Cerner Multum, Inc. and Infumorph Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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