6 ADVERSE REACTIONS
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)]
- Addiction, Abuse, and Misuse [see Warnings and Precautions (5.3)]
- Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)]
- Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.5)]
- Myoclonic Activity [see Warnings and Precautions (5.6)]
- Adrenal Insufficiency [see Warnings and Precautions (5.10)]
- Severe Hypotension [see Warnings and Precautions (5.11)]
- Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13)]
- Seizures [see Warnings and Precautions (5.14)]
- Withdrawal [see Warnings and Precautions (5.15)]
- Urinary Retention [see Warnings and Precautions (5.16)]
- Orthostatic Hypotension [see Warnings and Precautions (5.17)]
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 chronic use of opioids [see Clinical Pharmacology (12.2)].