morphine sulfate injection, USP VIAL Adverse Reactions

()

6 ADVERSE REACTIONS

The following serious adverse reactions are described, or described in greater detail, in other sections:

Addiction, Abuse, and Misuse [see Warnings and Precautions (5.2)]
Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)]
Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4)]
Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)]
Myoclonic Activity [see Warnings and Precautions (5.6)]
Opioid Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8)]
Adrenal Insufficiency [see Warnings and Precautions (5.11)]
Severe Hypotension [see Warnings and Precautions (5.12)]
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.14)]
Seizures [see Warnings and Precautions (5.15)]
Withdrawal [see Warnings and Precautions (5.16)]
Urinary Retention [see Warnings and Precautions (5.17)]
Orthostatic Hypotension [see Warnings and Precautions (5.18)]

The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these reactions were 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 serious adverse reactions encountered during administration of preservative-free morphine sulfate injection were respiratory depression and/or respiratory arrest.

Cardiovascular System: While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines.

Central Nervous System: Myoclonus, seizures, dysphoric reactions, toxic psychosis, dizziness, euphoria, anxiety, confusion, headache. Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation and generally responds to bed rest and/or other conventional therapy.

Gastrointestinal System: Nausea, vomiting, constipation.

Skin: Generalized pruritus, urticaria, wheals, and/or local tissue irritation. Single-dose epidural or intrathecal administration is accompanied by a high incidence of dose-related generalized pruritus.

Urinary System: Urinary retention, oliguria.

Peripheral edema: There are several reports of peripheral edema.

Other: Other adverse reactions reported following morphine therapy include depression of cough reflex, interference with thermal regulation, peripheral edema.

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 preservative-free morphine sulfate injection.

Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time. [see Clinical Pharmacology (12.2)].

Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.8)].

Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).

Find morphine sulfate injection, USP VIAL medical information:

Find morphine sulfate injection, USP VIAL medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

morphine sulfate injection, USP VIAL Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Adverse Reactions

6 ADVERSE REACTIONS

The following serious adverse reactions are described, or described in greater detail, in other sections:

Addiction, Abuse, and Misuse [see Warnings and Precautions (5.2)]
Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)]
Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4)]
Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)]
Myoclonic Activity [see Warnings and Precautions (5.6)]
Opioid Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8)]
Adrenal Insufficiency [see Warnings and Precautions (5.11)]
Severe Hypotension [see Warnings and Precautions (5.12)]
Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.14)]
Seizures [see Warnings and Precautions (5.15)]
Withdrawal [see Warnings and Precautions (5.16)]
Urinary Retention [see Warnings and Precautions (5.17)]
Orthostatic Hypotension [see Warnings and Precautions (5.18)]

The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these reactions were 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 serious adverse reactions encountered during administration of preservative-free morphine sulfate injection were respiratory depression and/or respiratory arrest.

Cardiovascular System: While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines.

Central Nervous System: Myoclonus, seizures, dysphoric reactions, toxic psychosis, dizziness, euphoria, anxiety, confusion, headache. Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation and generally responds to bed rest and/or other conventional therapy.

Gastrointestinal System: Nausea, vomiting, constipation.

Skin: Generalized pruritus, urticaria, wheals, and/or local tissue irritation. Single-dose epidural or intrathecal administration is accompanied by a high incidence of dose-related generalized pruritus.

Urinary System: Urinary retention, oliguria.

Peripheral edema: There are several reports of peripheral edema.

Other: Other adverse reactions reported following morphine therapy include depression of cough reflex, interference with thermal regulation, peripheral edema.

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 preservative-free morphine sulfate injection.

Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time. [see Clinical Pharmacology (12.2)].

Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.8)].

Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).

Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.