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Morphine (Morphine Sulfate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 Other CNS Depressants [see Warnings and Precautions]
  • Hypotensive Effect [see Warnings and Precautions]
  • Gastrointestinal Effects [see Warnings and Precautions]
  • Seizures [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.

Morphine sulfate extended-release tablets 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 tablets 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 effects

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 tablets: 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.

Anaphylaxis has been reported with ingredients contained in morphine sulfate extended-release tablets. Advise patients how to recognize such a reaction and when to seek medical attention.



REPORTS OF SUSPECTED MORPHINE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Morphine. The information is not vetted and should not be considered as verified clinical evidence.

Possible Morphine side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 59 year old male

Reactions: Drug Ineffective, Tension

Suspect drug(s):
Morphine

Other drugs received by patient: Ultram; Lasix; Meloxicam; Neurontin; Coreg; Coumadin; Lisinopril; Levothyroxine



Possible Morphine side effects / adverse reactions in 66 year old male

Reported by a pharmacist from United States on 2011-10-03

Patient: 66 year old male weighing 58.5 kg (128.7 pounds)

Reactions: Mental Status Changes

Adverse event resulted in: hospitalization

Suspect drug(s):
Morphine



Possible Morphine side effects / adverse reactions in 31 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2011-10-05

Patient: 31 year old female

Reactions: Back Pain, Pain in Extremity, Staphylococcal Infection

Suspect drug(s):
Morphine
    Dosage: 2 mg
    Indication: Procedural Pain

Morphine
    Dosage: 4 mg



See index of all Morphine side effect reports >>

Drug label data at the top of this Page last updated: 2014-05-23

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