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Naropin SDV Side Effects

Generic Name: ropivacaine

Note: This document contains side effect information about ropivacaine. Some of the dosage forms listed on this page may not apply to the brand name Naropin SDV.

For the Consumer

Applies to ropivacaine: injection solution

Along with its needed effects, ropivacaine (the active ingredient contained in Naropin SDV) 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 ropivacaine:

Less common or rare
  • Burning or prickling sensation
  • fever
  • itching

Check with your doctor as soon as possible if any of the following side effects occur while taking ropivacaine:

Less common or rare

For Healthcare Professionals

Applies to ropivacaine: injectable solution

General

Reactions to this drug are characteristic of those associated with other amide-type local anesthetics. A major cause of side effects can me associated with excessive plasma levels which may be due to overdose, unintentional intravascular injection, or slow metabolic degradation.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (up to 54.6%), bradycardia (up to 19.5%), fetal bradycardia (12.1%)
Common (1% to 10%): Hypertension, tachycardia, chest pain, fetal tachycardia, fetal distress
Uncommon (0.1% to 1%): Syncope, severe hypotension
Rare (less than 0.1%): Cardiac arrest, cardiac arrhythmia
Frequency not reported: Vasovagal reaction, postural hypotension, non-specific ECG abnormalities, extrasystole, nonspecific arrhythmia, atrial fibrillation, ST segment changes, myocardial infarction, deep vein thrombosis, phlebitis, pulmonary embolism[Ref]

Nervous system

Common (1% to 10%): Paresthesia, headache, dizziness, hypoesthesia
Uncommon (0.1% to 1%): CNS toxicity, convulsion, grand mal convulsions, seizure, lightheadedness, circumoral paresthesia, numbness of the tongue, hyperacusis, dysarthria, tremor
Frequency not reported: Horner's syndrome, paresis, dyskinesia, neuropathy, coma, convulsion, hypokinesia, hypotonia, ptosis, stupor, spinal cord dysfunction, anterior spinal artery syndrome, arachnoiditis, cauda equine, total spinal block, persistent anesthesia, weakness, paralysis of lower extremities, loss of sphincter control, septic meningitis[Ref]

Local

Frequency not reported: Injection site pain[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 29.4%), vomiting (up to 14.6%)
Common (1% to 10%): Neonatal vomiting
Frequency not reported: Fecal incontinence, tenesmus[Ref]

Other

Common (1% to 10%): Fever, pain, postoperative complication, rigors, neonatal complication, Apgar score low, neonatal fever, neonatal infection, temperature elevation, chills
Uncommon (0.1% to 1%): Tinnitus, hypothermia, neonatal sepsis
Frequency not reported: Malaise, asthenia, accident/injury, hearing abnormal, vertigo[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, oliguria, urinary tract infection, progression of labor poor/failed
Frequency not reported: Uterine atony, urinary incontinence, micturition disorder[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Rare (less than 0.1%): Angioedema, urticaria
Frequency not reported: Rash[Ref]

Hematologic

Common (1% to 10%): Anemia[Ref]

Hepatic

Common (1% to 10%): Neonatal jaundice
Frequency not reported: Jaundice[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, neonatal hypoglycemia
Uncommon (0.1% to 1%): Fetal acidosis
Frequency not reported: Hypomagnesemia[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 16.4%)
Common (1% to 10%): Cramps
Uncommon (0.1% to 1%): Muscular twitch, muscular rigidity, hypotonia
Frequency not reported: Myalgia[Ref]

Ocular

Frequency not reported: Vision abnormal, vision blurred, pupil constriction[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia
Frequency not reported: Agitation, confusion, somnolence, nervousness, amnesia, hallucination, emotional lability, nightmares, restlessness, drowsiness, unconsciousness[Ref]

Respiratory

Common (1% to 10%): Dyspnea, rhinitis, neonatal respiratory disorder, neonatal tachypnea, hypoxia, hypercapnia, apnea
Frequency not reported: Bronchospasm, coughing, underventilation, apnea, respiratory paralysis[Ref]

Endocrine

Common (1% to 10%): Breast disorder/breastfeeding disorder[Ref]

Immunologic

Rare (less than 0.1%): Allergic reaction, anaphylactic reaction[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Naropin (ropivacaine)." Astra USA, Westborough, MA.

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.

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