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Review Metoclopramide Safety Reports submitted to FDA

Total Metoclopramide reports: 37.
Metoclopramide FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 18.
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FDA Reported Metoclopramide Side Effects: dystonia, anaphylactic reaction, tardive dyskinesia, oculogyration, depression, anxiety, somnolence, tremor, asthenia, speech disorder, confusional state.
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Metoclopramide Side Effects Report #5671098-8
Health Professional from UNITED STATES reported METOCLOPRAMIDE problem on Mar 17, 2008. Female patient, 55 years of age, weighting 117.0 lb, was diagnosed with impaired gastric emptying and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: heart rate increased, hypertension, temporal lobe epilepsy. METOCLOPRAMIDE dosage: unknown. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5676008-5
METOCLOPRAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 07, 2008. Male patient, weighting 209.9 lb, was diagnosed with impaired gastric emptying and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: anxiety, depression, impaired gastric emptying, insomnia. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with PROMETHAZINE, TRAZODONE, WELLBUTRIN, AMITIZA, CLONAZEPAM, NEXIUM, GABAPENTIN, ZOFRAN. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5627135-X
Physician from UNITED STATES reported METOCLOPRAMIDE problem on Feb 12, 2008. Female patient, weighting 139.0 lb, was diagnosed with abdominal pain and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: athetosis, choreoathetosis, gait disturbance, tardive dyskinesia. METOCLOPRAMIDE dosage: 5MG QID PRN PO. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5635682-X
METOCLOPRAMIDE problem was reported by a Health Professional from UNITED KINGDOM on Jan 16, 2008. Male patient, 56 years of age, was diagnosed with nausea and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, pain in jaw. METOCLOPRAMIDE dosage: 10 MG;QID;PO. During the same period patient was treated with FLUOROURACIL. Patient died.

Metoclopramide Side Effects Report #5644246-3
Consumer or non-health professional from UNITED STATES reported METOCLOPRAMIDE problem on Feb 27, 2008. Female patient, 51 years of age, weighting 190.0 lb, was diagnosed with gastrooesophageal reflux disease and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: anxiety, crying, dyskinesia, grimacing, muscle twitching, social avoidant behaviour. METOCLOPRAMIDE dosage: 10 MG 3 TIMES A DAY PO. Patient recovered.

Metoclopramide Side Effects Report #5648193-2
METOCLOPRAMIDE problem was reported by a Health Professional from UNITED KINGDOM on Jan 18, 2008. Male patient, 27 years of age, was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: dystonia. METOCLOPRAMIDE dosage: 10 MG; TID; PO. During the same period patient was treated with FLUOXETINE, AMOXICILLIN. Patient recovered.

Metoclopramide Side Effects Report #5592618-8
Health Professional from UNITED STATES reported METOCLOPRAMIDE problem on Jan 02, 2008. Female patient, 36 years of age, weighting 135.0 lb, was diagnosed with mental disorder, nervous system disorder and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: anaemia, cardiomyopathy, catatonia, cerebral haemorrhage, cholestasis, clostridium difficile colitis, communication disorder, contusion, eyes sunken. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with VALPROIC ACID, GABAPENTIN, CLONAZEPAM, PHENYTOIN, CARBAZEPINE, KEPPRA, PRIMIDONE. Patient was hospitalized. Patient died.

Metoclopramide Side Effects Report #5598375-3
METOCLOPRAMIDE problem was reported by a Health Professional from UNITED KINGDOM on Jan 16, 2008. Male patient, 56 years of age, weighting 235.9 lb, was diagnosed with nausea, rectal cancer and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, pain in jaw. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with FLUOROURACIL. Patient died on 11/16/2007.

Metoclopramide Side Effects Report #5607627-X
Physician from UNITED STATES reported METOCLOPRAMIDE problem on Jan 25, 2008. Female patient, 36 years of age, weighting 166.0 lb, was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, anaphylactic reaction, back pain, blood creatine phosphokinase mb increased, blood pressure increased, breast discomfort, chest discomfort, chest pain, contrast media reaction. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with HYDROCODONE W, ZELNORM, CONTRAST MEDIA, DILAUDID, ANALGESICS. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5545772-8
METOCLOPRAMIDE problem was reported by a Consumer or non-health professional from AUSTRIA on Nov 27, 2007. Female patient, child 4 years of age, weighting 33.07 lb, was diagnosed with gastrointestinal infection and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: accidental overdose, altered state of consciousness, respiratory distress, tremor. METOCLOPRAMIDE dosage: unknown. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5553354-7
Consumer or non-health professional from UNITED STATES reported METOCLOPRAMIDE problem on Dec 12, 2007. Female patient, 40 years of age, weighting 135.0 lb, was diagnosed with constipation, irritable bowel syndrome and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: anxiety, decreased interest, depression, feeling of body temperature change, panic disorder, suicidal ideation. METOCLOPRAMIDE dosage: unknown. Patient recovered.

Metoclopramide Side Effects Report #5562921-6
METOCLOPRAMIDE problem was reported by a Pharmacist from SAUDI ARABIA on Dec 11, 2007. Female patient, weighting 110.2 lb, was diagnosed with nausea, vomiting and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: agitation, oculogyric crisis, photophobia, photosensitivity reaction. METOCLOPRAMIDE dosage: 10 MG TID IV BOLUS 3 DOSES. Patient recovered.

Metoclopramide Side Effects Report #5574669-2
Pharmacist from UNITED STATES reported METOCLOPRAMIDE problem on Dec 26, 2007. Male patient, 69 years of age, was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: confusional state. METOCLOPRAMIDE dosage: 5MG BID PO. During the same period patient was treated with TRAZODONE. Patient recovered.

Metoclopramide Side Effects Report #5503634-6
METOCLOPRAMIDE problem was reported by a Physician from JAPAN on Oct 22, 2007. Female patient, 76 years of age, was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with LEUCOVORIN CALCIUM, OXALIPLATIN, FLUOROURACIL. Patient recovered.

Metoclopramide Side Effects Report #5525641-X
Consumer or non-health professional from UNITED STATES reported METOCLOPRAMIDE problem on Nov 20, 2007. Male patient, 31 years of age, weighting 135.0 lb, was diagnosed with anorexia, blood pressure increased and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: decreased appetite, diarrhoea, hyperhidrosis, malaise, muscle twitching. METOCLOPRAMIDE dosage: unknown. Patient recovered.

Metoclopramide Side Effects Report #5485182-5
METOCLOPRAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 10, 2007. Female patient, 68 years of age, weighting 175.0 lb, was diagnosed with nausea, retching and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, fatigue, hypersomnia, tardive dyskinesia. METOCLOPRAMIDE dosage: 10MG PER MEAL PO. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5487279-2
Consumer or non-health professional from UNITED STATES reported METOCLOPRAMIDE problem on Sept 28, 2007. Male patient was diagnosed with gastrooesophageal reflux disease and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: anxiety, conversion disorder, extrapyramidal disorder, nausea, restless legs syndrome, tardive dyskinesia. METOCLOPRAMIDE dosage: 10 MG, TID, ORAL. During the same period patient was treated with REGLAN, PHENERGAN. Patient recovered.

Metoclopramide Side Effects Report #5487967-8
METOCLOPRAMIDE problem was reported by a Pharmacist from UNITED STATES on Oct 12, 2007. Female patient, 39 years of age, weighting 128.1 lb, was diagnosed with gastrointestinal motility disorder and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: bradycardia, cardiac arrest. METOCLOPRAMIDE dosage: 10MG Q6H IV. During the same period patient was treated with METOCLOPRAMIDE HYDROCHLORIDE. Patient recovered.

Metoclopramide Side Effects Report #5490496-9
Health Professional from UNITED STATES reported METOCLOPRAMIDE problem on Oct 17, 2007. Male patient, weighting 15.00 lb, was diagnosed with gastrooesophageal reflux disease and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: anxiety, choking, convulsion, dyskinesia, extrapyramidal disorder, restlessness. METOCLOPRAMIDE dosage: .3 ML EVERY 6 HOURS PO. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5499316-X
METOCLOPRAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 03, 2005. Female patient, 56 years of age, was diagnosed with gastrooesophageal reflux disease and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: blepharospasm, choking, crying, decreased appetite, depression, dry mouth, dyskinesia, dysphagia, dystonia. METOCLOPRAMIDE dosage: unknown. Patient recovered.

Metoclopramide Side Effects Report #5445833-8
Consumer or non-health professional from AUSTRIA reported METOCLOPRAMIDE problem on Aug 21, 2007. Female patient, child 4 years of age, weighting 33.07 lb, was diagnosed with gastrointestinal infection and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: accidental overdose, altered state of consciousness, incorrect dose administered, respiratory distress, tremor. METOCLOPRAMIDE dosage: unknown. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5449254-3
METOCLOPRAMIDE problem was reported by a Physician from UNITED KINGDOM on Aug 28, 2007. Female patient, 18 years of age, was diagnosed with malaise and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: balance disorder, dysphagia, feeling abnormal, joint lock, lethargy, oral pain, somnolence, speech disorder, trismus. METOCLOPRAMIDE dosage: 10 MG;TID. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5449507-9
Consumer or non-health professional from UNITED STATES reported METOCLOPRAMIDE problem on Aug 20, 2007. Female patient, 36 years of age, was diagnosed with mental disorder, convulsion and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy, catatonia, cerebral haemorrhage, conversion disorder, convulsion, dehydration, gliosis, hepatic necrosis, hyperchloraemia. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with VENLAFAXINE, LEVETIRACETAM, DIAZEPAM, PRIMIDONE, PHENYTOIN, CLONAZEPAM, VALPROIC ACID, GABAPENTIN. Patient died.

Metoclopramide Side Effects Report #5451366-5
METOCLOPRAMIDE problem was reported by a Pharmacist from UNITED STATES on Sept 11, 2007. Female patient, 46 years of age, weighting 141.1 lb, was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: dysphagia, hypokinesia, neuroleptic malignant syndrome, speech disorder, tremor. METOCLOPRAMIDE dosage: 10MG EVERY 6 HOURS PO. During the same period patient was treated with CALCIUM, OMEPRAZOLE, FLUOXETINE, GEMFIBROZIL, LITHIUM, LEVOTHYROXINE, TEMAZEPAM, HYDRALAZINE. Patient was hospitalized and became disabled. Patient recovered.

Metoclopramide Side Effects Report #5463100-3
Physician from UNITED STATES reported METOCLOPRAMIDE problem on Sept 18, 2007. Male patient, weighting 166.2 lb, was diagnosed with nausea and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: apnoea, nausea, oxygen saturation decreased, respiratory disorder. METOCLOPRAMIDE dosage: 10MG EVERY 5 HOURS IV BOLUS. During the same period patient was treated with OXYCODONE, MORPHINE, ASPIRIN, ATORVASTATIN CALCIUM, ESOMEPRAZOLE MAGNESIUM, HYDROCHLOROTHIAZIDE, METOPROLOL, AMPICILLIN AND SULBACTAM. Patient recovered.

Metoclopramide Side Effects Report #5472122-8
METOCLOPRAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 17, 2007. Female patient was diagnosed with diabetic gastroparesis and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, mental disorder, pain, tardive dyskinesia. METOCLOPRAMIDE dosage: 10 MG; QID; PO. Patient recovered.

Metoclopramide Side Effects Report #5476047-3
Consumer or non-health professional from UNITED STATES reported METOCLOPRAMIDE problem on July 18, 2006. Female patient, 59 years of age, was diagnosed with gastrooesophageal reflux disease and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: confusional state, depression, fatigue, suicidal ideation. METOCLOPRAMIDE dosage: 10 MG TABLET BID OR TID BEFORE MEALS (10MG), ORAL. During the same period patient was treated with ESOMEPRAZOLE. Patient recovered.

Metoclopramide Side Effects Report #5476054-0
METOCLOPRAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 07, 2006. Male patient was diagnosed with impaired gastric emptying and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: tardive dyskinesia. METOCLOPRAMIDE dosage: (10 MG), ORAL. Patient recovered.

Metoclopramide Side Effects Report #5476059-X
Health Professional from UNITED STATES reported METOCLOPRAMIDE problem on June 22, 2007. Female patient, 62 years of age, weighting 131.0 lb, was diagnosed with gastrooesophageal reflux disease and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: anxiety, asthenia, depression, malaise, somnolence, suicidal ideation. METOCLOPRAMIDE dosage: 40 MG (10 MG, 4 IN 1 D), ORAL. During the same period patient was treated with COLESTIPOL HYDROCHLORIDE, SUCRALFATE, LANSOPRAZOLE, ESOMEPRAZOLE MAGNESIUM, VITAMINS. Patient recovered.

Metoclopramide Side Effects Report #5407005-2
METOCLOPRAMIDE problem was reported by a Pharmacist from UNITED STATES on Aug 03, 2007. Female patient, 89 years of age, weighting 105.2 lb, was diagnosed with surgery and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: thrombocythaemia. METOCLOPRAMIDE dosage: 500 MG Q8H IV. During the same period patient was treated with ENALAPRIL MALEATE, FLUCONAZOLE, VANCOMYCIN, MORPHINE SULPHATE. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5419594-2
Health Professional from SWITZERLAND reported METOCLOPRAMIDE problem on Aug 10, 2007. Female patient, 26 years of age, was diagnosed with nausea, diarrhoea and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: dyskinesia, dystonia. METOCLOPRAMIDE dosage: TOTAL DAILY DOSE: 30 MG. During the same period patient was treated with CIPROFLOXACIN, LOPERAMIDE. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5422890-6
METOCLOPRAMIDE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 08, 2007. Female patient, 18 years of age, was diagnosed with malaise and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: balance disorder, dysphagia, feeling abnormal, impaired work ability, lethargy, oral pain, somnolence, speech disorder, trismus. METOCLOPRAMIDE dosage: 10 MG; TID. Patient was hospitalized. Patient recovered.

Metoclopramide Side Effects Report #5427275-4
Pharmacist from UNITED STATES reported METOCLOPRAMIDE problem on Aug 23, 2007. Male patient, 67 years of age, was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: blood urine present. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with NEURONTIN, RENAGEL. Patient recovered.

Metoclopramide Side Effects Report #5385224-1
METOCLOPRAMIDE problem was reported by a Physician from UNITED STATES on July 06, 2007. Female patient, 50 years of age, weighting 130.0 lb, was diagnosed with gastrooesophageal reflux disease, oesophagitis and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: arthralgia, oedema peripheral, vision blurred, visual acuity reduced. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with PROTONIX. Patient recovered.

Metoclopramide Side Effects Report #5397873-5
Pharmacist from UNITED STATES reported METOCLOPRAMIDE problem on July 23, 2007. Female patient, 73 years of age, weighting 135.0 lb, was diagnosed with vomiting and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: blood pressure systolic increased, dystonia, gastritis, pancreatitis. METOCLOPRAMIDE dosage: 10MG X1 IV. Patient recovered.

Metoclopramide Side Effects Report #5385224-1
METOCLOPRAMIDE problem was reported by a Physician from UNITED STATES on July 06, 2007. Female patient, 50 years of age, weighting 130.0 lb, was diagnosed with gastrooesophageal reflux disease, oesophagitis and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: arthralgia, oedema peripheral, vision blurred, visual acuity reduced. METOCLOPRAMIDE dosage: unknown. During the same period patient was treated with PROTONIX. Patient recovered.

Metoclopramide Side Effects Report #5397873-5
Pharmacist from UNITED STATES reported METOCLOPRAMIDE problem on July 23, 2007. Female patient, 73 years of age, weighting 135.0 lb, was diagnosed with vomiting and was treated with METOCLOPRAMIDE. After drug was administered, patient experienced the following problems/side effects: blood pressure systolic increased, dystonia, gastritis, pancreatitis. METOCLOPRAMIDE dosage: 10MG X1 IV. Patient recovered.