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U.S. Department of Health and Human Services

Safety

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Morphine Sulfate Tablets, 15 mg and 30 mg

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012

 

Summary View

6 ADVERSE REACTIONS

Digestive System: anorexia, biliary pain, dyspepsia, dysphagia, gastroenteritis, abnormal liver function tests, rectaldisorder, thirst

Endocrine: hypogonadism

Hemic and Lymphatic System: anemia, thrombocytopenia Metabolic and Nutritional Disorders: edema, weight loss

Musculoskeletal: skeletal muscle rigidity, decreased bone mineral density

Nervous System: abnormal dreams, abnormal gait, agitation, amnesia, anxiety, ataxia, confusion, convulsions, coma, delirium, depression, dry mouth, euphoria, hallucinations, lethargy, nervousness, abnormal thinking, tremor, vasodilation, vertigo, headache

Urogenital System: abnormal ejaculation, dysuria, impotence, decreased libido, oliguria, urinary retention or hesitancy, anti-diuretic effect, amenorrhea

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy

Teratogenic Effects (Pregnancy Category C) 

  • No formal studies to assess the teratogenic effects of morphine in animals have been conducted.  It is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Morphine should be given to a pregnant woman only if clearly needed......

17 PATIENT COUNSELING INFORMATION

  • Instruct patients not to combine morphine sulfate with central nervous system depressants (such as sleep aids, tranquilizers,  antihistamines, general anesthetics, phenothiazines, other opioids, and monoamine oxidase [MAO] inhibitors) except by the orders of the prescribing physician, and not to combine with alcohol because dangerous additive effects may occur, resulting in serious injury or death.
  • If patients have been receiving treatment with morphine sulfate for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose as abrupt discontinuation of the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication.
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