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Pentazocine Side Effects

For the Consumer

Applies to pentazocine: oral tablets

Warning

    Concomitant Use with Benzodiazepines or Other CNS Depressants
  • Concomitant use of opiates with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.416 417 418 700 701 702 703

  • Reserve concomitant use of opiate analgesics and benzodiazepines or other CNS depressants for patients in whom alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation.700 703 (See Specific Drugs and Laboratory Tests under Interactions.)

REMS:

FDA approved a REMS for pentazocine to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of pentazocine and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]).

Side effects include:

Dizziness, lightheadedness, euphoria, sedation, nausea.

For Healthcare Professionals

Applies to pentazocine: injectable solution

General

The most commonly occurring adverse reactions have included nausea, dizziness or lightheadedness, vomiting, and euphoria.

Dermatologic

Postmarketing reports: Soft tissue induration, nodules and cutaneous depressions at injection sites; ulceration (sloughing), severe sclerosis of the skin and subcutaneous tissues and, rarely, underlying muscle; diaphoresis, sting on injection, flushed skin including plethora, dermatitis including pruritus[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, facial edema, toxic epidermal necrolysis[Ref]

Nervous system

Serotonin syndrome has been reported during concomitant use of opioids with serotonergic drugs.[Ref]

Postmarketing reports: Dizziness, lightheadedness, sedation, headache, weakness, flushing, syncope, tremor, paresthesia

Opioids:

Postmarketing reports: Serotonin syndrome[Ref]

Psychiatric

Postmarketing reports: Depression, euphoria, confusion, disorientation, disturbed dreams, insomnia, irritability, excitement, hallucinations[Ref]

Respiratory

Postmarketing reports: Respiratory depression, dyspnea, transient apnea (in infants whose mothers received this drug during labor)[Ref]

Cardiovascular

Postmarketing reports: Circulatory depression, shock, hypertension, tachycardia, syncope[Ref]

Gastrointestinal

Postmarketing reports: Nausea, vomiting, constipation, dry mouth, taste alteration, diarrhea and cramps[Ref]

Hematologic

Depression of the white blood cell count is usually reversible.[Ref]

Postmarketing reports: Depression of the white blood cell count (especially granulocytes), moderate transient eosinophilia[Ref]

Other

Postmarketing reports: Tinnitus, chills[Ref]

Ocular

Postmarketing reports: Visual blurring and focusing difficulty, blurred vision, diplopia, miosis, nystagmus[Ref]

Genitourinary

Postmarketing reports: Urinary retention, alteration in rate or strength of labor contractions[Ref]

Endocrine

Opioids:

Postmarketing reports: Adrenal insufficiency, Androgen deficiency

Cases of adrenal insufficiency have been reported with opioid use, generally use greater than 1 month. Cases of androgen deficiency have been reported with chronic opioid use.

References

1. "Product Information. Talwin NX (pentazocine)." Sanofi Winthrop Pharmaceuticals, New York, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.