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Ketalar (Ketamine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ketalar (Ketamine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (40)
Life Threatening Events (4)

Reports by Reaction Type

Hydronephrosis (15)Urinary Tract Disorder (9)Off Label Use (7)Drug Ineffective (5)Cystitis Interstitial (5)Hypersensitivity (4)Alanine Aminotransferase Increased (4)Loss of Consciousness (3)Liver Function Test Abnormal (3)Cystitis Noninfective (3)Urticaria (2)Drug Abuse (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Ketalar (Ketamine). For a complete list or a specific selection of reports, please use the links above.

Possible Ketalar side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-08-20

Patient: 19 year old female

Reactions: Hydronephrosis, Cystitis, Ureteric Stenosis

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 18 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 18 year old female

Reactions: Dysuria, Biliary Dilatation, Pollakiuria, Micturition Urgency

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 25 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-20

Patient: 25 year old male

Reactions: Hydronephrosis, Alanine Aminotransferase Increased, Cystitis Interstitial

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 30 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-20

Patient: 30 year old male

Reactions: Hydronephrosis, Alanine Aminotransferase Increased, Cystitis Interstitial

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 26 year old male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-20

Patient: 26 year old male

Reactions: Hydronephrosis, Alanine Aminotransferase Increased, Cystitis Interstitial

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-20

Patient: 23 year old female

Reactions: Hydronephrosis, Alanine Aminotransferase Increased, Drug Abuse, Cystitis Interstitial

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 27 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 27 year old male

Reactions: Dysuria, Cholangitis, Biliary Dilatation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14

Patient: 67 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Posterior Reversible Encephalopathy Syndrome

Drug(s) suspected as cause:
Fentanyl
    Dosage: 0.1 mg, unk
    Indication: Induction of Anaesthesia

Fentanyl
    Dosage: 0.2 mg, intermittent

Ketalar
    Dosage: 50 mg, unk
    Indication: Induction of Anaesthesia

Ketalar
    Dosage: 40 mg, unk

Propofol
    Dosage: 50 mg, unk
    Indication: Induction of Anaesthesia

Remifentanil
    Indication: General Anaesthesia

Sevoflurane
    Dosage: 0.15 ?g/kg, hr
    Indication: General Anaesthesia

Other drugs received by patient: Benidipine; Rocuronium Bromide; Cipralan; Warfarin Sodium; Sugammadex; Heparin



Possible Ketalar side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-24

Patient: 52 year old male

Reactions: Liver Function Test Abnormal, Cystitis Noninfective

Drug(s) suspected as cause:
Ketalar
    Dosage: 60 mg, daily
    Administration route: Oral
    Indication: Analgesic Therapy
    Start date: 2006-02-01
    End date: 2009-01-01

Nevirapine
    Indication: HIV Infection

Trizivir
    Indication: HIV Infection

Other drugs received by patient: Oxycontin; Ramipril; Movicol Sachets; Oxycodone HCL; Amitriptyline Hydrochloride; Testosterone; Acetaminophen



Possible Ketalar side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-06

Patient: 52 year old male

Reactions: Liver Function Test Abnormal, Cystitis Noninfective

Drug(s) suspected as cause:
Ketalar

Other drugs received by patient: Testosterone; Oxycontin; Amitriptyline HCL; Acetaminophen; Movicol Sachets; Trizivir; Nevirapine; Ramipril; Oxycodone HCL



Possible Ketalar side effects in female

Reported by a health professional (non-physician/pharmacist) from Hong Kong on 2012-07-02

Patient: female

Reactions: Urinary Tract Disorder, Hydronephrosis, Contracted Bladder, Ureteric Stenosis

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 17 month old

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-29

Patient: 17 month old

Reactions: Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ketalar
    Indication: Induction of Anaesthesia

Rocuronium Bromide



Possible Ketalar side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-06-06

Patient: 61 year old female

Reactions: Off Label Use, Myoclonus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketalar
    Dosage: 1 mg, hr
    Indication: Epidural Analgesia

Morphine
    Dosage: 0.4 ng, hr

Morphine
    Dosage: 0.2 mg, hr
    Indication: Epidural Analgesia

Ropivacaine Hydrochloride
    Dosage: 0.2% at 4 ml/h
    Indication: Epidural Analgesia

Other drugs received by patient: Lyrica; Famvir; Ultracet



Possible Ketalar side effects in 26 year old male

Reported by a health professional (non-physician/pharmacist) from Malaysia on 2012-05-08

Patient: 26 year old male

Reactions: Atonic Urinary Bladder, Hydronephrosis, Urosepsis, Hepatic Cirrhosis

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 28 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-02

Patient: 28 year old female

Reactions: Off Label Use, Dyspnoea, Nausea, Hallucination, Visual, Drug Ineffective FOR Unapproved Indication, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketalar

Other drugs received by patient: Dalteparin Sodium; Gabapentin; Sennoside; Haloperidol; Acetaminophen; Diazepam; Baclofen; Pantoprazole; Spironolactone; Methylnaltrexone; Methadone HCL; Venlafaxine; Dexamethasone; Ketorolac Tromethamine; Magnesium Hydroxide TAB; Furosemide



Possible Ketalar side effects in 15 month old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-03-20

Patient: 15 month old male

Reactions: Extrapyramidal Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketalar

Other drugs received by patient: Analgesics; Sedatives



Possible Ketalar side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-03-13

Patient: 58 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Bronchospasm, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Diprivan
    Dosage: 130 mg
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-09

Ketalar
    Dosage: 25 mg
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-09

Rocuronium Bromide
    Dosage: 40 mg
    Indication: Induction of Anaesthesia
    Start date: 2011-09-09
    End date: 2011-09-09

Sufenta Preservative Free
    Dosage: 10 mcg
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-09

Other drugs received by patient: Trazodone HCL; Escitalopram Oxalate; D-Cure; Loramet; Seroquel



Possible Ketalar side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-03-09

Patient: 61 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Off Label Use, Ocular Toxicity, Corneal Oedema

Drug(s) suspected as cause:
Ketalar

Other drugs received by patient: Atorvastatin; Ezetimibe; Flecainide Acetate; Diazepam; Phenelzine; Tamsulosin HCL; Furosemide



Possible Ketalar side effects in 28 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-09

Patient: 28 year old female

Reactions: Off Label Use, Drug Ineffective, Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketalar

Other drugs received by patient: Antiinflammatory Agents; Gabapentin; Steroids; Methadon HCL TAB; Acetaminophen; Baclofen; Venlafaxine; Diazepam



Possible Ketalar side effects in

Reported by a consumer/non-health professional from United States on 2012-03-08

Patient:

Reactions: Hypersensitivity, Drug Ineffective

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in

Reported by a consumer/non-health professional from United States on 2012-03-08

Patient:

Reactions: Hypersensitivity, Drug Ineffective

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in

Reported by a consumer/non-health professional from United States on 2012-03-08

Patient:

Reactions: Incorrect Drug Administration Rate, Hypersensitivity, Drug Ineffective

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in

Reported by a consumer/non-health professional from United States on 2012-03-08

Patient:

Reactions: Hypersensitivity, Drug Ineffective

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 24 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-02-23

Patient: 24 year old female

Reactions: Bladder Perforation, Cystitis Noninfective

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 26 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-02-07

Patient: 26 year old female

Reactions: Urinary Tract Disorder, Hydronephrosis

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 26 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-02-07

Patient: 26 year old female

Reactions: Urinary Tract Disorder, Hydronephrosis

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 22 year old male

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-02-07

Patient: 22 year old male

Reactions: Urinary Tract Disorder, Hydronephrosis

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 28 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-02-07

Patient: 28 year old female

Reactions: Urinary Tract Disorder, Hydronephrosis, Pyelonephritis Acute

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 22 year old male

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-02-07

Patient: 22 year old male

Reactions: Hydronephrosis, Urinary Tract Disorder

Drug(s) suspected as cause:
Ketalar



Possible Ketalar side effects in 22 year old male

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-02-07

Patient: 22 year old male

Reactions: Hydronephrosis, Urinary Tract Disorder

Drug(s) suspected as cause:
Ketalar

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