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Bupivacaine Side Effects

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Common Bupivacaine Side Effects


The most commonly reported Bupivacaine side effects (click to view or check a box to report):

Anaesthetic Complication (48)
Chondrolysis (46)
Hypotension (44)
Convulsion (24)
Hearing Impaired (22)
Loss Of Consciousness (22)
Musculoskeletal Pain (20)
Pain (20)
Cardiac Arrest (19)
Grand Mal Convulsion (18)
Dyspnoea (17)
Bradycardia (14)
Blood Pressure Decreased (14)
Muscular Weakness (13)
Hypoaesthesia (13)
Apnoea (13)
Oxygen Saturation Decreased (12)
Cardio-respiratory Arrest (12)
Respiratory Distress (11)
Unresponsive To Stimuli (11)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Bupivacaine Side Effects Reported to FDA



Bupivacaine Side Effect Report#9993537
Fat Necrosis
This is a report of a 45-year-old male patient (weight: NA) from CH, suffering from the following health symptoms/conditions: abdominal pain upper, who was treated with Bupivacaine (dosage: 0.25% At 6 Ml/h (360mg Daily In 144ml); Changed To 0.5% At 3 Ml/h After 3m, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Fat Necrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bupivacaine treatment in male patients, resulting in Fat Necrosis side effect.
Bupivacaine Side Effect Report#9940437
Ventricular Tachycardia, Respiratory Distress, Accidental Overdose
This report suggests a potential Bupivacaine Ventricular Tachycardia side effect(s) that can have serious consequences. A 3-year-old female patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: epidural anaesthesia,ventricular tachycardia and used Bupivacaine (dosage: 10ml Of 0.25% Bupivacaine) starting NS. After starting Bupivacaine the patient began experiencing various side effects, including: Ventricular Tachycardia, Respiratory Distress, Accidental OverdoseAdditional drugs used concurrently:
  • Lipid Emulsion (15ml Of 20% Lipid Emulsion)
  • Lipid Emulsion (150 Ml/h Of 20% Lipid Emulsion)
  • Lipid Emulsion (5ml Of 20% Lipid Emulsion)
  • Epinephrine (30 Microg/kg)
  • Sevoflurane
  • Suxamethonium Chloride
  • Atracurium Besilate
  • Sevoflurane
Although Bupivacaine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ventricular Tachycardia, may still occur.
Bupivacaine Side Effect Report#9928339
Soft Tissue Necrosis
This Soft Tissue Necrosis problem was reported by a health professional from DE. A 45-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: breakthrough pain. On NS this consumer started treatment with Bupivacaine (dosage: Bupivacaine Hcl 0.25% And Morphine Hcl 0.005% In A 1,000 Ml Bag, Daily Dose Of Bupivacaine:360 Mg). The following drugs were being taken at the same time: NA. When using Bupivacaine, the patient experienced the following unwanted symptoms/side effects: Soft Tissue NecrosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Soft Tissue Necrosis, may become evident only after a product is in use by the general population.
Bupivacaine Side Effect Report#9863068
Myoclonus, Apnoea, Hypertension, Tachycardia, Extrasystoles, Metabolic Acidosis, Brain Oedema
This Myoclonus side effect was reported by a health professional from IN. A 37-year-old female patient (weight:NA) experienced the following symptoms/conditions: spinal anaesthesia.The patient was prescribed Bupivacaine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Tranexamic Acid
.After starting to take Bupivacaine the consumer reported adverse symptoms, such as: Myoclonus, Apnoea, Hypertension, Tachycardia, Extrasystoles, Metabolic Acidosis, Brain OedemaThese side effects may potentially be related to Bupivacaine. The patient was hospitalized.
Bupivacaine Side Effect Report#9862084
Myoclonus, Hypotension, Loss Of Consciousness, Ventricular Fibrillation
This is a report of a 55-year-old female patient (weight: NA) from IN, suffering from the following health symptoms/conditions: spinal anaesthesia, who was treated with Bupivacaine (dosage: NA, start time: NS), combined with:
  • Tranexamic Acid
and developed a serious reaction and side effect(s): Myoclonus, Hypotension, Loss Of Consciousness, Ventricular Fibrillation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bupivacaine treatment in female patients, resulting in Myoclonus side effect.
Bupivacaine Side Effect Report#9841470
No Therapeutic Response
This report suggests a potential Bupivacaine No Therapeutic Response side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: spinal anaesthesia and used Bupivacaine (dosage: 2 Ml Once Spinal) starting
Jan 22, 2014. After starting Bupivacaine the patient began experiencing various side effects, including: No Therapeutic ResponseAdditional drugs used concurrently:
  • Cefazolin
  • Midazolam Inj
Although Bupivacaine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as No Therapeutic Response, may still occur.
Bupivacaine Side Effect Report#9837776
Musculoskeletal Stiffness, Hypoaesthesia
This Musculoskeletal Stiffness problem was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: myalgia. On
Jan 03, 2013 this consumer started treatment with Bupivacaine Hcl (dosage: NA). The following drugs were being taken at the same time:
  • Celestone
When using Bupivacaine Hcl, the patient experienced the following unwanted symptoms/side effects: Musculoskeletal Stiffness, HypoaesthesiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Musculoskeletal Stiffness, may become evident only after a product is in use by the general population.
Bupivacaine Side Effect Report#9773141
Lethargy, Strabismus, Hypotonia, Somnolence, Feeding Disorder Neonatal, Altered State Of Consciousness
This Lethargy side effect was reported by a health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: local anaesthesia.The patient was prescribed Bupivacaine Hcl (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Bupivacaine Hcl the consumer reported adverse symptoms, such as: Lethargy, Strabismus, Hypotonia, Somnolence, Feeding Disorder Neonatal, Altered State Of ConsciousnessThese side effects may potentially be related to Bupivacaine Hcl. The patient was hospitalized.
Bupivacaine Side Effect Report#9758377
Anxiety, Aphasia, Tachypnoea, Mydriasis, Paraesthesia
This is a report of a 49-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: complex regional pain syndrome, who was treated with Bupivacaine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Anxiety, Aphasia, Tachypnoea, Mydriasis, Paraesthesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bupivacaine treatment in female patients, resulting in Anxiety side effect.
Bupivacaine Side Effect Report#9735600
Sensorimotor Disorder
This report suggests a potential Bupivacaine Sensorimotor Disorder side effect(s) that can have serious consequences. A 5-year-old patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: local anaesthesia and used Bupivacaine (dosage: NA) starting NS. After starting Bupivacaine the patient began experiencing various side effects, including: Sensorimotor DisorderAdditional drugs used concurrently:
  • Clonidine
  • O2:n2o
  • Sevoflurane
  • Fentanyl (1 Ug/kg)
The patient was hospitalized. Although Bupivacaine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sensorimotor Disorder, may still occur.
Bupivacaine Side Effect Report#9728370
Vith Nerve Paralysis, Gaze Palsy, Oxygen Saturation Decreased, Loss Of Consciousness
This Vith Nerve Paralysis problem was reported by a health professional from IN. A 35-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: spinal anaesthesia. On NS this consumer started treatment with Bupivacaine (dosage: NA). The following drugs were being taken at the same time: NA. When using Bupivacaine, the patient experienced the following unwanted symptoms/side effects: Vith Nerve Paralysis, Gaze Palsy, Oxygen Saturation Decreased, Loss Of ConsciousnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vith Nerve Paralysis, may become evident only after a product is in use by the general population.
Bupivacaine Side Effect Report#9713378
Cardiotoxicity
This Cardiotoxicity side effect was reported by a health professional from IN. A 3-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bupivacaine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Sevoflurane
  • Nitrous Oxide
  • Oxygen
  • Suxamethonium
.After starting to take Bupivacaine the consumer reported adverse symptoms, such as: CardiotoxicityThese side effects may potentially be related to Bupivacaine.
Bupivacaine Side Effect Report#9702179
Pain, Staphylococcal Infection, Unevaluable Event, Loss Of Consciousness
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthralgia, who was treated with Bupivacaine Hcl (dosage: Injection In L Knee, start time:
Oct 29, 2013), combined with:
  • All Therapeutic Products
and developed a serious reaction and side effect(s): Pain, Staphylococcal Infection, Unevaluable Event, Loss Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bupivacaine Hcl treatment in male patients, resulting in Pain side effect.
Bupivacaine Side Effect Report#9702172
Pain, Staphylococcus Test Positive
This report suggests a potential Bupivacaine Hcl Pain side effect(s) that can have serious consequences. A 49-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthralgia and used Bupivacaine Hcl (dosage: Injection) starting
Oct 29, 2013. After starting Bupivacaine Hcl the patient began experiencing various side effects, including: Pain, Staphylococcus Test PositiveAdditional drugs used concurrently: NA. Although Bupivacaine Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Bupivacaine Side Effect Report#9702163
Pain, Staphylococcus Test Positive, Joint Swelling, Arthralgia, Product Sterility Lacking, Exposure Via Contaminated Device
This Pain problem was reported by a consumer or non-health professional from Country Not Specified. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On
Oct 29, 2013 this consumer started treatment with Bupivacaine Hcl (dosage: NA). The following drugs were being taken at the same time:
  • Orthovisc
  • Betadine
  • Aspirin
  • Clomipramine
  • Hyzaar
  • Omeprazole
When using Bupivacaine Hcl, the patient experienced the following unwanted symptoms/side effects: Pain, Staphylococcus Test Positive, Joint Swelling, Arthralgia, Product Sterility Lacking, Exposure Via Contaminated DeviceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Bupivacaine Side Effect Report#9702132
Pain, Staphylococcal Infection, Myositis, Joint Swelling, Injection Site Reaction, No Therapeutic Response
This Pain side effect was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: pain.The patient was prescribed Bupivacaine Hcl (drug dosage: Approximately 5 Cc), which was initiated on
Oct 29, 2013. Concurrently used drugs:
  • Celestone
  • Betadine
  • Celebrex
  • Estrogen Nos W/methyltestosterone
  • Omeprazole
  • Tramadol
  • Ezetimibe
.After starting to take Bupivacaine Hcl the consumer reported adverse symptoms, such as: Pain, Staphylococcal Infection, Myositis, Joint Swelling, Injection Site Reaction, No Therapeutic ResponseThese side effects may potentially be related to Bupivacaine Hcl. The patient was hospitalized.
Bupivacaine Side Effect Report#9702121
Pain, Staphylococcal Infection
This is a report of a 58-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthralgia, who was treated with Bupivacaine Hcl (dosage: Injection, start time:
Oct 29, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pain, Staphylococcal Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bupivacaine Hcl treatment in female patients, resulting in Pain side effect.
Bupivacaine Side Effect Report#9696430
Hypotension, Ischaemic Cerebral Infarction, Maternal Exposure During Delivery
This report suggests a potential Bupivacaine Hypotension side effect(s) that can have serious consequences. A 29-year-old female patient (weight: NA) from CG was diagnosed with the following symptoms/conditions: caesarean section and used Bupivacaine (dosage: Isobaric) starting NS. After starting Bupivacaine the patient began experiencing various side effects, including: Hypotension, Ischaemic Cerebral Infarction, Maternal Exposure During DeliveryAdditional drugs used concurrently:
  • Fentanyl
The patient was hospitalized and became disabled. Although Bupivacaine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypotension, may still occur.
Bupivacaine Side Effect Report#9674951
Loss Of Consciousness
This Loss Of Consciousness problem was reported by a consumer or non-health professional from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 29, 2013 this consumer started treatment with Bupivacaine (dosage: NA). The following drugs were being taken at the same time: NA. When using Bupivacaine, the patient experienced the following unwanted symptoms/side effects: Loss Of ConsciousnessThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Loss Of Consciousness, may become evident only after a product is in use by the general population.
Bupivacaine Side Effect Report#9674936
Arthralgia
This Arthralgia side effect was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bupivacaine (drug dosage: NA), which was initiated on
Oct 29, 2013. Concurrently used drugs: NA..After starting to take Bupivacaine the consumer reported adverse symptoms, such as: ArthralgiaThese side effects may potentially be related to Bupivacaine. The patient was hospitalized.
Bupivacaine Side Effect Report#9674927
Arthralgia
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Bupivacaine (dosage: NA, start time:
Oct 29, 2013), combined with: NA. and developed a serious reaction and side effect(s): Arthralgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bupivacaine treatment in male patients, resulting in Arthralgia side effect. The patient was hospitalized.
Bupivacaine Side Effect Report#9674916
Arthralgia
This report suggests a potential Bupivacaine Arthralgia side effect(s) that can have serious consequences. A 90-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Bupivacaine (dosage: NA) starting
Oct 29, 2013. After starting Bupivacaine the patient began experiencing various side effects, including: ArthralgiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Bupivacaine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Arthralgia, may still occur.
Bupivacaine Side Effect Report#9674907
Pain
This Pain problem was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 29, 2013 this consumer started treatment with Bupivacaine (dosage: NA). The following drugs were being taken at the same time: NA. When using Bupivacaine, the patient experienced the following unwanted symptoms/side effects: PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Bupivacaine Side Effect Report#9674899
Pain
This Pain side effect was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bupivacaine (drug dosage: NA), which was initiated on
Oct 29, 2013. Concurrently used drugs: NA..After starting to take Bupivacaine the consumer reported adverse symptoms, such as: PainThese side effects may potentially be related to Bupivacaine. The patient was hospitalized.
Bupivacaine Side Effect Report#9674894
Pain
This is a report of a 43-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Bupivacaine (dosage: NA, start time:
Oct 29, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bupivacaine treatment in male patients, resulting in Pain side effect.


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The appearance of Bupivacaine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Bupivacaine Side Effects for Women?

Women Side EffectsReports
Hypotension 27
Anaesthetic Complication 22
Chondrolysis 17
Cardiac Arrest 12
Grand Mal Convulsion 12
Convulsion 11
Dyspnoea 11
Musculoskeletal Pain 11
Caesarean Section 10
Loss Of Consciousness 10

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Bupivacaine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Bupivacaine Safety Alerts, Active Ingredients, Usage Information

    NDC0409-1158
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameBupivacaine Hydrochloride
    NameBUPIVACAINE HYDROCHLORIDE
    Dosage FormINJECTION, SOLUTION
    RouteEPIDURAL; INFILTRATION; INTRACAUDAL
    On market since19870303
    LabelerHospira, Inc.
    Active Ingredient(s)BUPIVACAINE HYDROCHLORIDE
    Strength(s)2.5
    Unit(s)mg/mL
    Pharma ClassAmide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]

    Bupivacaine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 540

    Bupivacaine safety alerts: 2014 2013 2009

    Reported deaths: 32

    Reported hospitalizations: 67

    Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis

    Audience: Orthopedic and Anesthesia healthcare professionals, hospital risk managers

    [Posted 11/13/2009] FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

    Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

    This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.

    [11/13/2009 - Information for Healthcare Professionals - FDA]

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