Ketalar (Ketamine Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Cardiovascular: Blood pressure and pulse rate are frequently elevated following administration of Ketalar alone. However, hypotension and bradycardia have been observed. Arrhythmia has also occurred.

Respiration: Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid intravenous administration of high doses of Ketalar. Laryngospasms and other forms of airway obstruction have occurred during Ketalar anesthesia.

Eye: Diplopia and nystagmus have been noted following Ketalar administration. It also may cause a slight elevation in intraocular pressure measurement.

Psychological: (See Special Note.)

Neurological: In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures (see DOSAGE AND ADMINISTRATION Section).

Gastrointestinal: Anorexia, nausea and vomiting have been observed; however, this is not usually severe and allows the great majority of patients to take liquids by mouth shortly after regaining consciousness (see DOSAGE AND ADMINISTRATION Section).

General: Anaphylaxis. Local pain and exanthema at the injection site have infrequently been reported. Transient erythema and/or morbilliform rash have also been reported.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

REPORTS OF SUSPECTED KETALAR SIDE EFFECTS / ADVERSE REACTIONS

Possible Ketalar side effects / adverse reactions in 51 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-17

Patient: 51 year old male

Reactions: Cystitis Interstitial

Suspect drug(s):
Ketalar

Possible Ketalar side effects / adverse reactions in 48 year old male

Reported by a physician from France on 2011-10-17

Patient: 48 year old male

Reactions: Anaphylactic Shock, Cardiac Arrest

Adverse event resulted in: life threatening event

Suspect drug(s):
Celocurine
    Indication: Endotracheal Intubation
    Start date: 2011-09-07

Diprivan
    Start date: 2011-09-07

Ketalar
    Start date: 2011-09-07

Sufentanil Citrate
    Start date: 2011-09-07

Possible Ketalar side effects / adverse reactions in 56 year old male

Reported by a consumer/non-health professional from Japan on 2011-11-23

Patient: 56 year old male weighing 69.6 kg (153.1 pounds)

Reactions: Urticaria, Erythema

Adverse event resulted in: hospitalization

Suspect drug(s):
Cefazolin Sodium
    Dosage: 1 gm;bid;indrp
    Indication: Infection Prophylaxis
    Start date: 2011-08-25
    End date: 2011-08-25

Cefazolin Sodium
    Dosage: 1 gm;bid;indrp
    Indication: Infection Prophylaxis
    Start date: 2011-08-26
    End date: 2011-08-26

Diprivan
    Dosage: 70 mg;iv 20 mg;iv
    Indication: Induction of Anaesthesia
    Start date: 2011-08-26
    End date: 2011-08-26

Ketalar
    Dosage: 20 mg;iv 30 mg;iv
    Indication: Induction of Anaesthesia
    Start date: 2011-08-26
    End date: 2011-08-26

Rocuronium Bromide
    Dosage: 45 mg;iv
    Indication: Neuromuscular Blocking Therapy
    Start date: 2011-08-26
    End date: 2011-08-26

Ultiva
    Dosage: indrp
    Indication: Induction of Anaesthesia
    Start date: 2011-08-26
    End date: 2011-08-26

Other drugs received by patient: Sennoside; Heavy Magnesium Oxide; Celecoxib; Diazepam; Rabeprazole Sodium; Roxatidine Acetate HCL