Note: This document contains side effect information about meperidine. Some dosage forms listed on this page may not apply to the brand name Demerol.
Applies to meperidine: oral solution, oral syrup, oral tablet. Other dosage forms:
- injection solution
Warning
Oral route (Tablet; Solution)
Ensure accuracy when prescribing, dispensing, and administering meperidine hydrochloride oral solution. Dosing errors due to confusion between mg and mL, and other meperidine hydrochloride oral solutions of different concentrations can result in accidental overdose and death. Meperidine hydrochloride has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of meperidine hydrochloride, especially in children, can result in fatal overdose of meperidine hydrochloride. Prolonged use of meperidine hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use or discontinuation of concomitantly used cytochrome P450 3A4 inhibitors may effect meperidine plasma concentrations and lead to fatal respiratory depression, profound sedation, opioid toxicity, and/or opioid withdrawal. Careful monitoring of patients should occur when meperidine and cytochrome P450 3A4 inhibitors are concurrently used. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. Concomitant use of meperidine hydrochloride with MAOIs or use of MAOIs within the last 14 days is contraindicated and can lead to coma, severe respiratory depression, cyanosis, and hypotension.
Serious side effects of Demerol
Along with its needed effects, meperidine (the active ingredient contained in Demerol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking meperidine:
Incidence not known
- Agitation
- blurred vision
- chest pain or discomfort
- cold, clammy skin
- confusion
- cough
- darkening of the skin
- decrease in the frequency of urination
- decrease in urine volume
- diarrhea
- difficult or trouble breathing
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, slow, pounding, or irregular heartbeat
- feeling of warmth
- fever
- hives, itching, or skin rash
- irregular, fast, slow, or shallow breathing
- lightheadedness, dizziness, or fainting
- loss of appetite
- mental depression
- muscle twitching or jerking
- nausea
- overactive reflexes
- painful urination
- pale or blue lips, fingernails, or skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- restlessness
- rhythmic movement of the muscles
- seizures
- shakiness in the legs, arms, hands, or feet
- shivering
- sweating
- talking or acting with excitement you cannot control
- tightness in the chest
- trembling or shaking of the hands or feet
- twitching
- unusual tiredness or weakness
- upper abdominal or stomach pain
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur while taking meperidine:
Symptoms of overdose
- Bluish color of the fingernails, lips, skin, palms, or nail beds
- change in consciousness
- decreased awareness or responsiveness
- loss of consciousness
- severe sleepiness
- sleepiness or unusual drowsiness
Other side effects of Demerol
Some side effects of meperidine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Drowsiness
- relaxed and calm feeling
Incidence not known
- Blurred or loss of vision
- confusion about identity, place, and time
- deep or fast breathing with dizziness
- difficulty having a bowel movement
- disturbed color perception
- double vision
- dry mouth
- false or unusual sense of well-being
- halos around lights
- headache
- irritability
- nervousness
- night blindness
- numbness of the feet, hands, and around the mouth
- overbright appearance of lights
- redness of the skin
- seeing, hearing, or feeling things that are not there
- trouble sleeping
- tunnel vision
For Healthcare Professionals
Applies to meperidine: compounding powder, injectable solution, intravenous solution, oral syrup, oral tablet.
General
The most frequently reported adverse reactions have included lightheadedness, dizziness, sedation, nausea, vomiting, and sweating.[Ref]
Respiratory
Frequency not reported: Respiratory depression, respiratory arrest[Ref]
Nervous system
Frequency not reported: Serotonin syndrome, hyperexcitability, convulsions, weakness, headache, tremor, involuntary muscle movements (e.g. muscle twitches, myoclonus), delirium, dizziness, drowsiness, fainting, neurotoxicity, lightheadedness[Ref]
Therapeutic doses of this drug have precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received MAOIs within 14 days of receiving this drug. The mechanism of this reaction is unclear, but may be related to preexisting hyperphenylalaninemia. Reactions have included coma, severe respiratory depression, cyanosis, and hypotension. IV hydrocortisone or prednisolone have been used to treat severe reactions, with IV chlorpromazine used in cases exhibiting hypertension and hyperpyrexia. The usefulness and safety of narcotic antagonists is unknown.
Neurotoxicity associated with increased concentrations of active metabolite have occurred. Reactions have included a range of excitatory effects including tremor, hallucinations, seizures, coma, and mood changes.[Ref]
Psychiatric
Frequency not reported: Mood changes (e.g. euphoria, dysphoria), agitation, transient hallucinations and disorientation, confusion, dependence, anxiety, nervousness[Ref]
Cardiovascular
Frequency not reported: Severe hypotension, orthostatic hypotension, syncope, shock, cardiac arrest, circulatory depression, flushing, tachycardia, bradycardia, palpitations, hypotension, hypertension[Ref]
Hypersensitivity
Frequency not reported: Wheel and flare over the vein with IV injection, hypersensitivity reactions, anaphylaxis, histamine release leading to hypotension and/or tachycardia, sweating, flushing, and pruritus[Ref]
Local
Inadvertent injection about a nerve trunk may result in sensory-motor paralysis which is usually transitory. Phlebitis has been reported following IV injection.[Ref]
Frequency not reported: Sensory-motor paralysis, phlebitis, injection site pain, local tissue irritation and induration following subcutaneous injection[Ref]
Other
Frequency not reported: Vertigo, hypothermia[Ref]
Genitourinary
Frequency not reported: Urinary retention, micturition difficulties, decreased libido, renal colic, anuria[Ref]
Gastrointestinal
Frequency not reported: Dry mouth, constipation, biliary tract spasm, nausea, vomiting, decreased gastric emptying[Ref]
Dermatologic
Frequency not reported: Pruritus, urticaria, other skin rashes, sweating[Ref]
Musculoskeletal
Frequency not reported: Muscle twitching, muscle rigidity[Ref]
Endocrine
Frequency not reported: Adrenal insufficiency, androgen deficiency[Ref]
Hepatic
Frequency not reported: Biliary spasm, choledochoduodenal sphincter spasm[Ref]
Renal
Frequency not reported: Antidiuretic effect[Ref]
Ocular
Frequency not reported: Visual disturbances, dry eye, pupillary constriction, miosis, decreased corneal reflex, mydriasis[Ref]
Metabolic
Frequency not reported: Anorexia[Ref]
