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Remifentanil adverse events reported to FDA.

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Summary

FDA Adverse Reports: 18. View All

Remifentanil FDA safety alerts: No

Reported hospitalizations: 2

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Often additional risks of using a medication, such as Remifentanil, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Remifentanil users, Learn more about unwanted side effects & find ways to reduce them. Browse Remifentanil Adverse Reports reported to FDA and participate in Remifentanil discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Remifentanil. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Remifentanil Adverse Effect Reports (FDA)

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5988474-6 | Vocal Cord Disorder
on Dec 02, 2008 Female patient from JAPAN , 54 years of age, weighting 123.5 lb, was treated with Remifentanil (View Usage). Patient experienced the following unwanted or unexpected effects: vocal cord disorder. Remifentanil dosage: . During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ).

5988407-2 | Vocal Cord Disorder
Patient was taking Remifentanil (View Usage). Patient had the following side effects: vocal cord disorder on Dec 02, 2008 from JAPAN Additional patient health information: Female patient , 43 years of age, weighting 125.7 lb, was diagnosed with anaesthesia and. Remifentanil dosage: . During the same period patient was treated with PROPOFOL (View Propofol Review and Propofol Label ), SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), OXYGEN (View Oxygen Review and Oxygen Label ), AIR (View Air Review and Air Label ).

5988406-0 | Vocal Cord Disorder
Adverse event was reported on Dec 02, 2008 by a Female patient taking Remifentanil (View Usage) (Dosage: ) was diagnosed with anaesthesia and. Location: JAPAN , 57 years of age, weighting 143.3 lb, After Remifentanil was administered, patient had the following side effects: vocal cord disorder. During the same period patient was treated with PROPOFOL (Not Reported) (View Propofol Review and Propofol Label ), SEVOFLURANE (1-1.5%) (View Sevoflurane Review and Sevoflurane Label ), AIR (View Air Review and Air Label ), OXYGEN (View Oxygen Review and Oxygen Label ).

5955166-9 | Chills, Pulmonary Oedema
on Nov 07, 2008 Female patient from JAPAN , 47 years of age, was diagnosed with maintenance of anaesthesia, induction of anaesthesia, postoperative analgesia and was treated with Remifentanil (View Usage). Patient experienced the following unwanted or unexpected effects: chills, pulmonary oedema. Remifentanil dosage: . During the same period patient was treated with SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), PROPOFOL (View Propofol Review and Propofol Label ), ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ), OXYGEN (View Oxygen Review and Oxygen Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ).


5953116-2 | Agitation, Blood Pressure Increased, Heart Rate Increased, Muscle Contractions Involuntary
on Nov 05, 2008 Male patient from JAPAN , 19 years of age, weighting 152.1 lb, was diagnosed with sedation and was treated with Remifentanil (View Usage). Patient had the following side effects: agitation, blood pressure increased, heart rate increased, muscle contractions involuntary. Remifentanil dosage: 0.5 Mcg/kg/min. During the same period patient was treated with PROPOFOL (1.5 Mcg/ml, Rate Adjusted Throughout Operation) (View Propofol Review and Propofol Label ), NITROUS OXIDE (Not Reported) (View Nitrous Oxide Review and Nitrous Oxide Label ), LIDOCAINE HYDROCHLORIDE (1.8 Ml Of 2%) (View Lidocaine Hydrochloride Review and Lidocaine Hydrochloride Label ), EPINEPHRINE (Not Reported) (View Epinephrine Review and Epinephrine Label ), FLURBIPROFEN ACETYL (View Flurbiprofen Acetyl Review and Flurbiprofen Acetyl Label ), OXYGEN (3 L/min) (View Oxygen Review and Oxygen Label ).

5941839-0 | Chills, Pulmonary Oedema
Patient was taking Remifentanil (View Usage). After Remifentanil was administered, patient had the following side effects: chills, pulmonary oedema on Oct 28, 2008 from JAPAN Additional patient health information: Female patient , 47 years of age, was diagnosed with maintenance of anaesthesia, induction of anaesthesia, postoperative analgesia and. Remifentanil dosage: . During the same period patient was treated with SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), PROPOFOL (View Propofol Review and Propofol Label ), ROCURONIUM BROMIDE (View Rocuronium Bromide Review and Rocuronium Bromide Label ), OXYGEN (View Oxygen Review and Oxygen Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ).

5919619-1 | Agitation, Muscle Contractions Involuntary
Adverse event was reported on Oct 06, 2008 by a Male patient taking Remifentanil (View Usage) (Dosage: 0.5 Mcg/kg/min) was diagnosed with sedation and. Location: JAPAN , 19 years of age, Patient experienced the following unwanted or unexpected effects: agitation, muscle contractions involuntary. During the same period patient was treated with PROPOFOL (1.5 Mcg/ml, Rate Adjusted Throughout Operation) (View Propofol Review and Propofol Label ), NITROUS OXIDE (Not Reported) (View Nitrous Oxide Review and Nitrous Oxide Label ), LIDOCAINE HYDROCHLORIDE (Not Reported) (View Lidocaine Hydrochloride Review and Lidocaine Hydrochloride Label ), EPINEPHRINE (Not Reported) (View Epinephrine Review and Epinephrine Label ), FLURBIPROFEN ACETYL (Not Reported) (View Flurbiprofen Acetyl Review and Flurbiprofen Acetyl Label ).

5754374-X | Hyperaesthesia
on May 22, 2008 Female patient from SPAIN , 46 years of age, weighting 138.9 lb, was diagnosed with maintenance of anaesthesia, induction of anaesthesia, epidural anaesthesia, anxiety (What is anxiety?) and was treated with Remifentanil (View Usage). Patient had the following side effects: hyperaesthesia. Remifentanil dosage: Continuous Perfusion 0.3-0.9 Mcg/kg/min. During the same period patient was treated with SEVOFLURANE (View Sevoflurane Review and Sevoflurane Label ), FENTANYL 100 (View Fentanyl-100 Review and Fentanyl-100 Label ), FENTANYL 100 (4 Mcg/ml At 4 Ml/hr And 3ml Bolus) (View Fentanyl-100 Review and Fentanyl-100 Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), PROPOFOL (View Propofol Review and Propofol Label ), CISATRACURIUM (View Cisatracurium Review and Cisatracurium Label ).

5460691-3 | Sedation
on Sep 11, 2007 Female patient from SPAIN , 36 years of age, was diagnosed with pain (What is pain?), analgesia and was treated with Remifentanil (View Usage). After Remifentanil was administered, patient had the following side effects: sedation. Remifentanil dosage: . During the same period patient was treated with PARACETAMOL (View Paracetamol Review and Paracetamol Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), FENTANYL (View Fentanyl Review and Fentanyl Label ), ROPIVACAINE (0.375% 2 Ml/h With Boluses Of 2 Ml) (View Ropivacaine Review and Ropivacaine Label ), GABAPENTIN (View Gabapentin Review and Gabapentin Label ), AMITRIPTYLINE HCL (View Amitriptyline Hcl Review and Amitriptyline Hcl Label ), CLONAZEPAM (View Clonazepam Review and Clonazepam Label ).

5460676-7 | Acute Coronary Syndrome
Patient was taking Remifentanil (View Usage). Patient experienced the following unwanted or unexpected effects: acute coronary syndrome on Sep 11, 2007 from BRAZIL Additional patient health information: Male patient , 71 years of age, weighting 174.2 lb, was diagnosed with anaesthesia, induction of anaesthesia and. Remifentanil dosage: . During the same period patient was treated with METFORMIN HCL (View Metformin Hcl Review and Metformin Hcl Label ), LOSARTAN POSTASSIUM (View Losartan Postassium Review and Losartan Postassium Label ), DILTIAZEM (View Diltiazem Review and Diltiazem Label ), GLYCERYL TRINITRATE (View Glyceryl Trinitrate Review and Glyceryl Trinitrate Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), PROPOFOL (View Propofol Review and Propofol Label ), CISATRACURIUM (View Cisatracurium Review and Cisatracurium Label ).

5306933-6 | Anaesthetic Complication, Hypotension
Adverse event was reported on Apr 17, 2007 by a Male patient taking Remifentanil (View Usage) (Dosage: ) was diagnosed with anaesthesia, induction of anaesthesia and. Location: BELGIUM , 76 years of age, Patient had the following side effects: anaesthetic complication, hypotension. During the same period patient was treated with NIMBEX (View Nimbex Review and Nimbex Label ), PROPOFOL (View Propofol Review and Propofol Label ).

5239884-6 | Cyanosis, Loss Of Consciousness, Respiratory Depression
on Feb 06, 2007 Female patient from KOREA, REPUBLIC OF , 27 years of age, was diagnosed with postoperative analgesia and was treated with Remifentanil (View Usage). After Remifentanil was administered, patient had the following side effects: cyanosis, loss of consciousness, respiratory depression. Remifentanil dosage: . During the same period patient was treated with ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ).

5239883-4 | Apnoea, Cyanosis, Respiratory Depression
on Feb 06, 2007 Female patient from KOREA, REPUBLIC OF , 46 years of age, was diagnosed with postoperative analgesia and was treated with Remifentanil (View Usage). Patient experienced the following unwanted or unexpected effects: apnoea, cyanosis, respiratory depression. Remifentanil dosage: . During the same period patient was treated with CIMETIDINE HCL (View Cimetidine Hcl Review and Cimetidine Hcl Label ), FLUSH SOLUTION (View Flush Solution Review and Flush Solution Label ).

5094470-6 | Apnoea, Bradycardia, Hyperglycaemia, Hypotension, Hypoxic Encephalopathy, Loss Of Consciousness
Patient was taking Remifentanil (View Usage). Patient had the following side effects: apnoea, bradycardia, hyperglycaemia, hypotension, hypoxic encephalopathy, loss of consciousness on Aug 22, 2006 from UNITED STATES Additional patient health information: Female patient , 57 years of age, weighting 191.8 lb, was diagnosed with sedation, analgesic effect, spinal anaesthesia and. Remifentanil dosage: Not Reported. During the same period patient was treated with BUPIVACAINE (Isobaric) (View Bupivacaine Review and Bupivacaine Label ). Patient was hospitalized.

5066712-4 | Bradycardia, Cardiac Arrest
Adverse event was reported on Jul 25, 2006 by a Female patient taking Remifentanil (View Usage) (Dosage: ) . Location: SPAIN , 82 years of age, weighting 132.3 lb, After Remifentanil was administered, patient had the following side effects: bradycardia, cardiac arrest (What is cardiac arrest?). During the same period patient was treated with DIGOXIN (.25mg See Dosage Text) (View Digoxin Review and Digoxin Label ), FUROSEMIDE (40mg Per Day) (View Furosemide Review and Furosemide Label ), ENOXAPARIN SODIUM (40mg Per Day) (View Enoxaparin Sodium Review and Enoxaparin Sodium Label ), GLICLAZIDE (80mg Twice Per Day) (View Gliclazide Review and Gliclazide Label ), POTASSIUM SALT (View Potassium Salt Review and Potassium Salt Label ), COLLOID (View Colloid Review and Colloid Label ), OXYGEN (View Oxygen Review and Oxygen Label ), ETOMIDATE (View Etomidate Review and Etomidate Label ).

5015676-8 | Agitation, Coma, Eye Movement Disorder, Hyperhidrosis, Hyperreflexia, Hypertonia, Intentional Overdose, Muscle Rigidity
on May 17, 2006 Female patient from ARGENTINA , 66 years of age, was treated with Remifentanil (View Usage). Patient experienced the following unwanted or unexpected effects: agitation, coma, eye movement disorder, hyperhidrosis, hyperreflexia, hypertonia, intentional overdose, muscle rigidity. Remifentanil dosage: 5.7ugk See Dosage Text. During the same period patient was treated with TRANYLCYPROMINE (View Tranylcypromine Review and Tranylcypromine Label ), TRIFLUOPERAZINE HYDROCHLORIDE (View Trifluoperazine Hydrochloride Review and Trifluoperazine Hydrochloride Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), FLUOXETINE (View Fluoxetine Review and Fluoxetine Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ), PANCURONIUM BROMIDE (View Pancuronium Bromide Review and Pancuronium Bromide Label ). Patient was hospitalized.

4885681-0 | Apnoea, Hypoxia
on Jan 09, 2006 Female patient from UNITED STATES , child 9 years of age, was diagnosed with sedation, analgesic effect and was treated with Remifentanil (View Usage). Patient had the following side effects: apnoea, hypoxia. Remifentanil dosage: Bolus Dose. During the same period patient was treated with BENZODIAZEPINE (View Benzodiazepine Review and Benzodiazepine Label ), OXYGEN (View Oxygen Review and Oxygen Label ).

4634327-5 | Hypotonia, Oxygen Saturation Decreased
Patient was taking Remifentanil (View Usage). After Remifentanil was administered, patient had the following side effects: hypotonia, oxygen saturation decreased on Apr 04, 2005 from Additional patient health information: Female patient , weighting 6.21 lb, . Remifentanil dosage: .


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Remifentanil risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Remifentanil quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Remifentanil use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Remifentanil Reactions
Acute Coronary Syndrome
Agitation
Anaesthetic Complication
Apnoea
Blood Pressure Increased
Bradycardia
Cardiac ArrestWhat is Cardiac arrest?
Chills
Coma
Cyanosis
Eye Movement Disorder
Heart Rate Increased
Hyperaesthesia
Hyperglycaemia
Hyperhidrosis
Hyperreflexia
Hypertonia
Hypotension
Hypotonia
Hypoxia
Hypoxic Encephalopathy
Intentional Overdose
Loss Of Consciousness
Muscle Contractions Involuntary
Muscle Rigidity
Oxygen Saturation Decreased
Pulmonary Oedema
Respiratory Depression
Sedation
Vocal Cord Disorder
Remifentanil Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Remifentanil adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!