Home FDA labels 75465ceb-e894-487d-aa80-671fa0841fce Naropin openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Naropin
Generic name ROPIVACAINE HYDROCHLORIDE
Manufacturer Fresenius Kabi USA, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 56dfabf7-f7a8-4601-b17a-cb16fb995b0f
SPL ID 75465ceb-e894-487d-aa80-671fa0841fce
Version 5
Effective date 2024-05-22
Source export date 2026-09-28
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:03:18 Harmonized routes table Harmonized routes EPIDURAL
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warnings WARNINGS: In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an IV line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after insuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (see also ADVERSE REACTIONS , PRECAUTIONS and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES ). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2 nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2 to 3 minutes, extended to the T10 level in 10 to 13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Naropin and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
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adverse reactions table <table><caption>Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Postoperative Pain Management, Peripheral Nerve Block and Local Infiltration) </caption><tbody><tr><td rowspan="2" align="left" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold"> Adverse Reaction</content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"> <paragraph><content styleCode="bold">Naropin</content></paragraph><content styleCode="bold">total N=1661</content></td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"> <paragraph><content styleCode="bold">Bupivacaine</content></paragraph><content styleCode="bold">total N=1433</content></td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold">N</content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Hypotension </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 536 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(32.3) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 408 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(28.5) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Nausea </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 283 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(17) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 207 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(14.4) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Vomiting </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">117</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(7) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 88</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(6.1) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Bradycardia </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 96 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(5.8) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 73</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(5.1) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Headache </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 84 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(5.1) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 68</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4.7) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Paresthesia </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">82</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4.9) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 57</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Back pain </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">73</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4.4) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 75</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(5.2) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Pain </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">71</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4.3) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 71</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(5) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Pruritus </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 63 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(3.8) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 40</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.8) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Fever </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 61 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(3.7) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 37 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.6) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Dizziness </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">42</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.5) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 23</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.6) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Rigors (Chills) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">42</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.5) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 24</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (1.7) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Postoperative complications </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 41 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.5) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 44 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(3.1) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Hypoesthesia </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 27 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.6) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 24</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.7) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Urinary retention </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">23</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.4) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 20</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.4) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Progression of labor poor/failed </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">23</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.4) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 22</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.5) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Anxiety </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 21 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.3) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 11</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(0.8) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Breast disorder, breast-feeding </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 21 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.3) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 12 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(0.8) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Rhinitis </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">18 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.1) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 13 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (0.9) </td></tr></tbody></table>
adverse reactions table <table><caption>Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies) </caption><tbody><tr><td rowspan="2" align="left" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold">Adverse Reaction</content></td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="bold">Naropin </content></paragraph><content styleCode="bold">total N=639 </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="bold">Bupivacaine </content></paragraph><content styleCode="bold">total N=573 </content> </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold"> N</content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Fetal bradycardia </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 77</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(12.1) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 68 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(11.9) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Neonatal jaundice </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 49 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(7.7) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 47 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(8.2) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Neonatal complication-NOS </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 42 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(6.6) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 38 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(6.6) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Apgar score low </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 18 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.8) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 14 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.4) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Neonatal respiratory disorder </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">17</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.7) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 18</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(3.1) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Neonatal tachypnea </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 14 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.2) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 15 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.6) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Neonatal fever </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 13 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 14 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.4) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Fetal tachycardia </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">13</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">12</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.1) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Fetal distress </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">11</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.7) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">10</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.7) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Neonatal infection </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 10 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.6) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 8 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.4) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> Neonatal hypoglycemia </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 8 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.3) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">16 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(2.8) </td></tr></tbody></table>
adverse reactions table <table><caption>Table 4 Common Events (Epidural Administration) </caption><tbody><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> <paragraph><content styleCode="bold">Adverse</content></paragraph><content styleCode="bold">Reaction</content></td><td colspan="6" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">Naropin </content> </td><td colspan="4" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">Bupivacaine </content></td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="bold">5 mg/mL </content></paragraph><content styleCode="bold"> total N=256 </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="bold">7.5 mg/mL </content></paragraph><content styleCode="bold"> total N=297 </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="bold">10 mg/mL </content></paragraph><content styleCode="bold"> total N=207 </content></td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="bold">5 mg/mL </content></paragraph><content styleCode="bold"> total N=236 </content></td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><paragraph><content styleCode="bold">7.5 mg/mL </content></paragraph><content styleCode="bold"> total N=174 </content></td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> N </content> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold">(%)</content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold">N</content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold">(%)</content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold">(%)</content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content></td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> hypotension</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 99 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (38.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 146</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (49.2)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">113</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (54.6)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">91</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(38.6)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">89</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(51.1)</td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> nausea</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 34</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (13.3)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 68</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (22.9)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"/><td align="center" styleCode="Lrule Rrule Toprule Botrule"> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">41</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(17.4)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">36</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(20.7)</td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> bradycardia</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 29 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (11.3)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 58</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (19.5)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">40</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (19.3)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">32</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(13.6)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">25</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(14.4)</td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> back pain</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 18 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 23</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (7.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">34</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (16.4)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">21</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(8.9)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">23</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(13.2)</td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> vomiting</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 18 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 33</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (11.1)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">23</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (11.1)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">19</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(8.1)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">14</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(8)</td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> headache</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 12</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (4.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 20</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (6.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">16</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (7.7) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">13</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(5.5)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">9</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(5.2)</td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> fever</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 8</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (3.1)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 5</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (1.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">18</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (8.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">11</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"/><td align="center" styleCode="Lrule Rrule Toprule Botrule"/></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> chills</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 6</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (2.3)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 7</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (2.4)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">6</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (2.9)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">4</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">3</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(1.7)</td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"><paragraph> urinary</paragraph> retention </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 5</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (2)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 8</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (2.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">10</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (4.8)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">10</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4.2)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"/><td align="center" styleCode="Lrule Rrule Toprule Botrule"/></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> paresthesia</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 5</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (2)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 10</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (3.4) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">5</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (2.4)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">7</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(3)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"/><td align="center" styleCode="Lrule Rrule Toprule Botrule"/></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> pruritus </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 14</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (4.7)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">3</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (1.4)</td><td align="center" styleCode="Lrule Rrule Toprule Botrule"/><td align="center" styleCode="Lrule Rrule Toprule Botrule"/><td align="center" styleCode="Lrule Rrule Toprule Botrule">7</td><td align="center" styleCode="Lrule Rrule Toprule Botrule">(4)</td></tr></tbody></table>
adverse reactions table <table><caption>Table 5 Effects of Age on Hypotension (Epidural Administration) Total N: Naropin = 760, bupivacaine = 410 </caption><tbody><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> </td><td colspan="6" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">Naropin </content> </td><td colspan="4" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> Bupivacaine </content> </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> AGE </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> 5 mg/mL </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> 7.5 mg/mL </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> 10 mg/mL </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">5 mg/mL </content> </td><td colspan="2" align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> 7.5 mg/mL </content> </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> <content styleCode="bold">N</content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold"> N </content></td><td align="center" styleCode="Lrule Rrule Toprule Botrule"><content styleCode="bold">(%) </content> </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> < 65 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 68 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (32.2) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 99 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (43.2) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">87 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (51.5) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 64 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (33.5) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">73 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (48.3) </td></tr><tr><td align="left" styleCode="Lrule Rrule Toprule Botrule"> ≥ 65 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 31 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (68.9) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 47 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (69.1) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule">26 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (68.4) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 27 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (60) </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> 16 </td><td align="center" styleCode="Lrule Rrule Toprule Botrule"> (69.6)</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.