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Review Ketorolac Safety Reports submitted to FDA

Total Ketorolac reports: 14.
Ketorolac FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 8.
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FDA Reported Ketorolac Side Effects: renal failure acute, dyspnoea, necrotising fasciitis, nausea, chest pain, epilepsy, emotional disorder, electroneuromyography, chromaturia, bulbar palsy, acute polyneuropathy.
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Ketorolac Side Effects Report #5684296-4
Pharmacist from GERMANY reported KETOROLAC problem on Mar 27, 2008. Male patient, 31 years of age, was diagnosed with pain and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction, laceration, loss of consciousness, muscle spasms, urinary incontinence. KETOROLAC dosage: 60 ML IM 1 DOSE IM. Patient recovered.

Ketorolac Side Effects Report #5684879-1
KETOROLAC problem was reported by a Pharmacist from UNITED STATES on Feb 09, 1996. Female patient, 13 years of age, weighting 90.39 lb, was diagnosed with back pain and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, activated partial thromboplastin time abnormal, hepatic enzyme increased, intra-abdominal haemorrhage, leukopenia, prothrombin time abnormal, thrombocytopenia, vomiting. KETOROLAC dosage: unknown. During the same period patient was treated with ANTIBIOTIC NOS. Patient was hospitalized. Patient died on 05/20/1995.

Ketorolac Side Effects Report #5614016-0
Health Professional from UNITED KINGDOM reported KETOROLAC problem on Jan 25, 2008. Male patient, 36 years of age, was diagnosed with depression, neuromuscular block prolonged, anaesthesia and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: coma, conversion disorder. KETOROLAC dosage: unknown. During the same period patient was treated with ATRACURIUM BESYLATE, CIPRAMIL, FENTANYL CITRATE, FENTANYL CITRATE, GLYCOPYRRONIUM BROMIDE, ISOFLURANE, NEOSTIGMINE, NITROUS OXIDE. Patient was hospitalized. Patient recovered.

Ketorolac Side Effects Report #5621928-0
KETOROLAC problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 25, 2008. Female patient, 36 years of age, was diagnosed with neuromuscular blockade, depression, endotracheal intubation, anaesthesia and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: coma, conversion disorder, eye movement disorder, gaze palsy, neurological examination abnormal, post procedural complication. KETOROLAC dosage: 30 MG (10 MIN AFTER INDUCTION). During the same period patient was treated with FENTANYL, NEOSTIGMINE, CITALOPRAM HYDROBROMIDE, ATRACURIUM BESYLATE, GLYCOPYRRONIUM, NITROUS OXIDE W, THIOPENTONE. Patient was hospitalized. Patient recovered.

Ketorolac Side Effects Report #5662557-2
Physician from UNITED STATES reported KETOROLAC problem on Nov 20, 2007. Female patient, 56 years of age, was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: eye penetration, skin disorder, ulcerative keratitis. KETOROLAC dosage: unknown. During the same period patient was treated with NEPAFENAC, PREDNISOLONE, MOXIFLOXACIN UNK. Patient recovered.

Ketorolac Side Effects Report #5602629-1
KETOROLAC problem was reported by a Health Professional from UNITED KINGDOM on Jan 17, 2008. Male patient, 36 years of age, was diagnosed with endotracheal intubation, depression, neuromuscular blockade, anaesthesia and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: coma, conversion disorder. KETOROLAC dosage: unknown. During the same period patient was treated with ATRACURIUM, CITALOPRAM HYDROBROMIDE, FENTANYL CITRATE, FENTANYL CITRATE, GLYCOPYRRONIUM, ISOFLURANE, NEOSTIGMINE, NITROUS OXIDE. Patient was hospitalized. Patient recovered.

Ketorolac Side Effects Report #5614651-X
Consumer or non-health professional from UNITED STATES reported KETOROLAC problem on Jan 02, 2008. Female patient, 47 years of age, was diagnosed with back pain, pain in extremity and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: dysphasia, dysphemia, photophobia, speech disorder, swollen tongue, tremor. KETOROLAC dosage: 60 MG, INTRAMUSCULAR. During the same period patient was treated with KETOROLAC TROMETHAMINE, TRAMADOL, LODINE, THYROID SUPPLEMENT, HYDROCHLOROTHIAZIDE, MICROGESTIN. Patient recovered.

Ketorolac Side Effects Report #5566694-2
KETOROLAC problem was reported by a Health Professional from UNITED STATES on Dec 17, 2007. Female patient was diagnosed with fibromyalgia and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: oedema peripheral, pain in extremity. KETOROLAC dosage: 30MG TWICE A DAY IM. Patient recovered.

Ketorolac Side Effects Report #5570294-8
Pharmacist from UNITED STATES reported KETOROLAC problem on Dec 19, 2007. Male patient, 41 years of age, weighting 256.0 lb, was diagnosed with joint sprain and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea, nausea. KETOROLAC dosage: 60MG ONCE IM. Patient died on 08/18/2007.

Ketorolac Side Effects Report #5579032-6
KETOROLAC problem was reported by a Physician from UNITED STATES on Dec 18, 2007. Female patient was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: injection site abscess. KETOROLAC dosage: 60 MG, ONCE, INTRAMUSCULAR. Patient was hospitalized. Patient recovered.

Ketorolac Side Effects Report #5526407-7
Pharmacist from UNITED STATES reported KETOROLAC problem on Nov 21, 2007. Male patient, 60 years of age, was diagnosed with pain and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: chest pain, renal failure acute, renal tubular necrosis. KETOROLAC dosage: 10 MG PRN PO. Patient was hospitalized. Patient recovered.

Ketorolac Side Effects Report #5530423-9
KETOROLAC problem was reported by a Pharmacist from UNITED STATES on Nov 27, 2007. Male patient, 68 years of age, was diagnosed with pain and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: renal failure acute. KETOROLAC dosage: 15MG ONCE IM. Patient recovered.

Ketorolac Side Effects Report #5444963-4
Health Professional from GEORGIA reported KETOROLAC problem on Sept 05, 2007. Female patient, 26 years of age, was diagnosed with pancreatitis acute and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: abortion induced, acute polyneuropathy, bulbar palsy, chromaturia, dyspnoea, electroneuromyography, emotional disorder, epilepsy. KETOROLAC dosage: unknown. During the same period patient was treated with METAMIZOLE, DICLOFENAC. Patient was hospitalized. Patient recovered.

Ketorolac Side Effects Report #5445811-9
KETOROLAC problem was reported by a Health Professional from GEORGIA on Sept 05, 2007. Female patient, 26 years of age, was diagnosed with pancreatitis acute and was treated with KETOROLAC. After drug was administered, patient experienced the following problems/side effects: abortion induced, acute polyneuropathy, bulbar palsy, chromaturia, dyspnoea, electroneuromyography, emotional disorder, epilepsy. KETOROLAC dosage: unknown. During the same period patient was treated with METAMIZOLE, DICLOFENAC. Patient was hospitalized. Patient recovered.


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anaphylactoid reaction, laceration, loss of consciousness, muscle spasms, urinary incontinence, abdominal pain, activated partial thromboplastin time abnormal, hepatic enzyme increased, intra-abdominal haemorrhage, leukopenia, prothrombin time abnormal, thrombocytopenia, vomiting, , was diagnosed with pain and was diagnosed with back pain and was diagnosed with depression, neuromuscular block prolonged, anaesthesia and