"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Diprivan Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Diprivan (propofol) Injectable Emulsion is used to help you relax before and during general anesthesia for surgery or other medical procedure. It is also used in critically ill patients who require a breathing tube connected to a ventilator. It is a sedative-hypnotic agent. This medication is available in generic form. Common side effects include nausea, cough, slight burning or stinging around the IV needle, mild itching or skin rash, numbness or tingly feeling, confusion, agitation, anxiety, muscle pain, or discolored urine.
Diprivan is administered under a physician's supervision. Dose depends on the condition being treated and the patient's weight. Diprivan may interact with chloral hydrate, droperidol, barbiturates, diazepam or similar medicines, or narcotics. Tell your doctor all medications you use. Diprivan is not expected to be harmful to a fetus. Tell your doctor if you are pregnant before you are treated with this drug. This medication can pass into breast milk and may harm a nursing baby. Consult your doctor before breast-feeding.
Our Diprivan (propofol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Diprivan in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pain, swelling, blisters, or skin changes where the medicine was injected;
- seizure (convulsions);
- weak or shallow breathing; or
- fast or slow heart rate.
Less serious side effects may include:
- slight burning or stinging around the IV needle;
- mild itching or skin rash;
- numbness or tingly feeling;
- confusion, agitation, anxiety;
- muscle pain; or
- discolored urine.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Diprivan (Propofol) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Diprivan FDA Prescribing Information: Side Effects
Adverse event information is derived from controlled clinical trials and worldwide marketing experience. In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient.
Anesthesia And MAC Sedation In Adults
The following estimates of adverse events for DIPRIVAN Injectable Emulsion include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with DIPRIVAN Injectable Emulsion was greater than the comparator incidence rate in these trials. Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship.
The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with DIPRIVAN Injectable Emulsion during anesthesia (see below). During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea.
Anesthesia In Pediatric Patients
Generally the adverse experience profile from reports of 506 DIPRIVAN Injectable Emulsion pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with DIPRIVAN Injectable Emulsion during anesthesia in adults (see Pediatric percentages [Peds %] below). Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients.
ICU Sedation In Adults
The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients). Probably related incidence rates for ICU sedation were determined by individual case report form review. Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge. In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown. Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship.
Incidence greater than 1% - Probably Causally Related
|Anesthesia/MAC Sedation||ICU Sedation|
|Arrhythmia [Peds: 1.2%]|
|Tachycardia Nodal [Peds: 1.6%]|
|Hypotension* [Peds: 17%] (see also CLINICAL PHARMACOLOGY)||Decreased Cardiac Output|
|Hypertension [Peds: 8%]||Hypotension 26%|
|Central Nervous System:||Movement* [Peds: 17%]|
|Injection Site:||Burning/Stinging or Pain, 17.6% [Peds: 10%]|
|Respiratory:||Apnea (see also CLINICAL PHARMACOLOGY)||Respiratory Acidosis During Weaning*|
|Skin and Appendages:||Rash [Peds: 5%] Pruritus [Peds: 2%]|
|Events without an * or % had an incidence of 1% to 3%
*Incidence of events 3% to 10%
Incidence less than 1% - Probably Causally Related
|Anesthesia/MAC Sedation||ICU Sedation|
|Body as a Whole:||Anaphylaxis/Anaphylactoid Reaction Perinatal Disorder
[Premature Ventricular Contractions]
|Cardiovascular:||Premature Atrial Contractions Syncope|
|Central Nervous System:||Hypertonia/Dystonia, Paresthesia||Agitation|
|Decreased Lung Function|
|Skin and Appendages:||Flushing, Pruritus|
|Urogenital:||Cloudy Urine||Green Urine|
Incidence less than 1% - Causal Relationship Unknown
|Anesthesia/MAC Sedation||ICU Sedation|
|Body as a Whole:||Asthenia, Awareness, Chest Pain, Extremities Pain, Fever, Increased Drug Effect, Neck Rigidity/Stiffness, Trunk Pain||Fever, Sepsis, Trunk Pain, Whole Body Weakness|
|Cardiovascular:||Arrhythmia, Atrial Fibrillation, Atrioventricular Heart Block, Bigeminy, Bleeding, Bundle Branch Block, Cardiac Arrest, ECG Abnormal, Edema, Extrasystole, Heart Block, Hypertension, Myocardial Infarction, Myocardial Ischemia, Premature Ventricular Contractions, ST Segment Depression, Supraventricular Tachycardia, Tachycardia, Ventricular Fibrillation||Arrhythmia, Atrial Fibrillation, Bigeminy, Cardiac Arrest, Extrasystole, Right Heart Failure, Ventricular Tachycardia|
|Central Nervous System:||Abnormal Dreams, Agitation, Amorous Behavior, Anxiety, Bucking/Jerking/Thrashing, Chills/Shivering/Clonic/Myoclonic Movement, Combativeness, Confusion, Delirium, Depression, Dizziness, Emotional Lability, Euphoria, Fatigue, Hallucinations, Headache, Hypotonia, Hysteria, Insomnia, Moaning, Neuropathy, Opisthotonos, Rigidity, Seizures, Somnolence, Tremor, Twitching||Chills/Shivering, Intracranial Hypertension, Seizures, Somnolence, Thinking Abnormal|
|Digestive:||Cramping, Diarrhea, Dry Mouth, Enlarged Parotid, Nausea, Swallowing, Vomiting||Ileus, Liver Function Abnormal|
|Hematologic/ Lymphatic:||Coagulation Disorder, Leukocytosis|
|Injection Site:||Hives/Itching, Phlebitis, Redness/Discoloration|
|Metabolic/ Nutritional:||Hyperkalemia, Hyperlipemia||BUN Increased, Creatinine Increased, Dehydration, Hyperglycemia, Metabolic Acidosis, Osmolality Increased|
|Respiratory:||Bronchospasm, Burning in Throat, Cough, Dyspnea, Hiccough, Hyperventilation, Hypoventilation, Hypoxia, Laryngospasm, Pharyngitis, Sneezing, Tachypnea, Upper Airway Obstruction||Hypoxia|
|Skin and Appendages:||Conjunctival Hyperemia, Diaphoresis,||Rash|
|Special Senses:||Diplopia, Ear Pain, Eye Pain,|
|Nystagmus, Taste Perversion,|
|Urogenital:||Oliguria, Urine Retention||Kidney Failure|
Drug Abuse And Dependence
There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. Instances of self-administration of DIPRIVAN Injectable Emulsion by health care professionals have also been reported, which have resulted in fatalities and other injuries. Inventories of DIPRIVAN Injectable Emulsion should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.
Read the entire FDA prescribing information for Diprivan (Propofol) »
Additional Diprivan Information
Report Problems to the Food and Drug Administration
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.
Find out what women really need.