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Dotarem Safety Reports
Total Dotarem reports: 28.Dotarem FDA safety alerts: No.
Reported deaths: 3 Reported hospitalizations: 10.
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Reported Dotarem Side Effects: vomiting, loss of consciousness, nephrogenic systemic fibrosis, nausea, nephrogenic fibrosing dermopathy, cardiac arrest, throat tightness, venous stasis, malaise, procedural complication, myalgia.
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Dotarem Side Effects Report #5207984-2
Consumer or non-health professional from UNITED KINGDOM reported DOTAREM problem on Mar 13, 2006. Female patient, 26 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: injection site abscess, injection site extravasation, skin graft. DOTAREM dosage: 15 ML, MILLILITRE(S), 1,7, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with PROTIRELIN, THYROTROPHIN, SYNACTHENE, LIDOCAINE. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5207985-4
DOTAREM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Dec 19, 2006. Male patient, 38 years of age, was diagnosed with arteriogram carotid and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: injection site pain, paraesthesia, sneezing, throat tightness, unresponsive to stimuli. DOTAREM dosage: unknown. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5210322-2
Consumer or non-health professional from UNITED KINGDOM reported DOTAREM problem on Dec 19, 2006. Male patient, 38 years of age, weighting 169.8 lb, was diagnosed with arteriogram carotid and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, injection site pain, injection site reaction, paraesthesia, sneezing, speech disorder, throat tightness. DOTAREM dosage: unknown. During the same period patient was treated with WARFARIN, SIMVASTATIN. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5233956-8
DOTAREM problem was reported by a Consumer or non-health professional from ITALY on Jan 25, 2007. Male patient, 47 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, cerebral haemorrhage, grand mal convulsion. DOTAREM dosage: 20 ML MILLILITRE (S), 1, ?, TOTAL. Patient died.
Dotarem Side Effects Report #5243416-6
Consumer or non-health professional from ITALY reported DOTAREM problem on Jan 25, 2007. Male patient, 47 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, cerebral haemorrhage, dysgeusia, grand mal convulsion, pupillary reflex impaired, retching. DOTAREM dosage: 20, ML MILLILITRE (S), 1, ?, TOTAL INTRAVENOUS (NOT OTHERWISE SPECIFIED). Patient died.
Dotarem Side Effects Report #5300074-X
DOTAREM problem was reported by a Consumer or non-health professional from SWITZERLAND on Mar 27, 2007. Female patient, 23 years of age, weighting 63.00 lb, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: cough, erythema, feeling hot, flushing, throat tightness. DOTAREM dosage: 15, ML MILLILITRE(S), , ?, TOTAL INTRAVENOUS (NOT OTHERWISE SPECIFIED). Patient recovered.
Dotarem Side Effects Report #5306467-9
Consumer or non-health professional from AUSTRIA reported DOTAREM problem on Mar 30, 2007. Female patient was diagnosed with arteriogram renal, nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: arterial disorder, nephrogenic fibrosing dermopathy, renal transplant, skin lesion, transplant rejection. DOTAREM dosage: unknown. During the same period patient was treated with CYCLOSPORINE. Patient recovered.
Dotarem Side Effects Report #5319740-5
DOTAREM problem was reported by a Consumer or non-health professional from FRANCE on May 03, 2007. Male patient, 56 years of age, weighting 187.4 lb, was diagnosed with nuclear magnetic resonance imaging brain and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: headache, hyperhidrosis, tachycardia, vomiting. DOTAREM dosage: unknown. Patient recovered.
Dotarem Side Effects Report #5320924-0
Consumer or non-health professional from FRANCE reported DOTAREM problem on Apr 23, 2007. Male patient was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, clonic convulsion, coma, loss of consciousness, respiratory distress, vomiting. DOTAREM dosage: 20 ML MILLITRE, TOTAL; INTRAVENOUS. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5330555-4
DOTAREM problem was reported by a Consumer or non-health professional from SPAIN on May 07, 2007. Female patient, 51 years of age, was diagnosed with nuclear magnetic resonance imaging abdominal and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: respiratory failure, throat irritation. DOTAREM dosage: unknown. Patient recovered.
Dotarem Side Effects Report #5331817-7
Consumer or non-health professional from FRANCE reported DOTAREM problem on Apr 25, 2007. Female patient, 48 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: calciphylaxis, eczema, nephrogenic fibrosing dermopathy, prurigo. DOTAREM dosage: 15, ML MILLILITRE(S) INTRAVENOUS. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5337048-9
DOTAREM problem was reported by a Consumer or non-health professional from SWITZERLAND on May 10, 2007. Male patient, 68 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: arthralgia, complications of transplanted kidney, cough, disease progression, haemodialysis, leg amputation, nephrogenic fibrosing dermopathy, osteomyelitis chronic, renal failure. DOTAREM dosage: unknown. During the same period patient was treated with OMNISCAN, PROHANCE, ULTRAVIST, TELEBRIX. Patient was hospitalized and became disabled. Patient recovered.
Dotarem Side Effects Report #5337049-0
Consumer or non-health professional from FRANCE reported DOTAREM problem on Apr 20, 2007. Male patient, 56 years of age, weighting 187.4 lb, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: headache, hyperhidrosis, nausea, tachycardia, vomiting. DOTAREM dosage: unknown. Patient recovered.
Dotarem Side Effects Report #5343423-9
DOTAREM problem was reported by a Consumer or non-health professional from FRANCE on Apr 23, 2007. Male patient, 65 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, clonic convulsion, coma, contrast media reaction, loss of consciousness, respiratory distress, vomiting. DOTAREM dosage: 20, ML MILLILITRE(S), , ?, TOTAL. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5343424-0
Consumer or non-health professional from FRANCE reported DOTAREM problem on Apr 25, 2007. Female patient, 48 years of age, weighting 119.0 lb, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, anti-hbs antibody, back pain, bone pain, c-reactive protein increased, cardiomegaly, dermatitis, haemoglobin decreased, reticulocyte count abnormal. DOTAREM dosage: 15, ML MILLILTRE(S), , ?, TOTAL. During the same period patient was treated with NEORECORMON, PERFALGAN, POLARAMINE, CLONAZEPAM, DUROGESIC MATRIX, RENAGEL, OROCAL, LEVOTHYROX. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5347014-5
DOTAREM problem was reported by a Consumer or non-health professional from FRANCE on May 23, 2007. Female patient was diagnosed with nuclear magnetic resonance imaging abdominal and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, vertigo. DOTAREM dosage: unknown. Patient recovered.
Dotarem Side Effects Report #5347035-2
Consumer or non-health professional from BELGIUM reported DOTAREM problem on May 22, 2007. Female patient was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: burning sensation, disturbance in social behaviour, myalgia, sensory disturbance. DOTAREM dosage: 15, ML MILLILITRE (S), 1, TOTAL. Patient recovered.
Dotarem Side Effects Report #5369950-6
DOTAREM problem was reported by a Physician from BELGIUM on May 22, 2007. Female patient, 70 years of age, weighting 114.6 lb, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: burning sensation, myalgia, tinnitus. DOTAREM dosage: 15, ML (S), 1, TOTAL; INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with PRILOSEC, PIRACETAM, SPIRONOLACTONE, ESTRADIOL, CARDIOSPIRINE. Patient recovered.
Dotarem Side Effects Report #5375680-7
Consumer or non-health professional from ITALY reported DOTAREM problem on June 15, 2007. Male patient, 41 years of age, was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: dizziness, unevaluable event. DOTAREM dosage: unknown. Patient recovered.
Dotarem Side Effects Report #5134060-X
DOTAREM problem was reported by a Consumer or non-health professional from GERMANY on Oct 05, 2006. Female patient, 47 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: erythema, hypotonia, procedural complication, pruritus, rash, urticaria. DOTAREM dosage: 20, ML MILLILITRE(S), 1, TOTAL INTRAVENOUS (NOT OTHERWISE SPECIFIED). Patient recovered.
Dotarem Side Effects Report #5159178-7
Health Professional from GERMANY reported DOTAREM problem on Nov 07, 2006. Female patient, 43 years of age, was diagnosed with nuclear magnetic resonance imaging brain and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: asthma, nausea, vomiting. DOTAREM dosage: 15, ML MILLILITRE (S), 1, ?, TOTAL INTRAVENOUS. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5181015-5
DOTAREM problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Mar 13, 2006. Female patient, 26 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: extravasation, injection site abscess. DOTAREM dosage: 15, MILLILITRE(S), 1, INTRAVENOUS. During the same period patient was treated with GONADORELIN, PROTIRELIN, THYROTROPHIN, SYNACTHENE, TETRACOSACTIDE, LIDOCAINE. Patient was hospitalized. Patient recovered.
Dotarem Side Effects Report #5191926-2
Consumer or non-health professional from FRANCE reported DOTAREM problem on Nov 29, 2006. Female patient was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: malaise, nausea, procedural complication, syncope vasovagal. DOTAREM dosage: unknown. Patient recovered.
Dotarem Side Effects Report #5388687-0
DOTAREM problem was reported by a Consumer or non-health professional from SWITZERLAND on May 07, 2007. Female patient, 67 years of age, was diagnosed with angiogram, nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: arterial bypass operation, arteriosclerosis, nephrogenic systemic fibrosis, panniculitis, venous stasis. DOTAREM dosage: 20, ML MILLITRE (S), 1, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with GADOVIST, IOPAMIDOL. Patient recovered.
Dotarem Side Effects Report #5401926-2
Consumer or non-health professional from FRANCE reported DOTAREM problem on May 23, 2007. Female patient, 47 years of age, weighting 143.3 lb, was diagnosed with nuclear magnetic resonance imaging abdominal and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, malaise, vertigo. DOTAREM dosage: 15, ML MILLILITRE(S), 1, 1, TOTAL INTRAVENOUS (NOT OTHERWISE SPECIFIED). Patient recovered.
Dotarem Side Effects Report #5450968-X
DOTAREM problem was reported by a Consumer or non-health professional from SWITZERLAND on July 05, 2007. Female patient, 67 years of age, was diagnosed with angiogram, nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: colitis, fibrosis, necrosis, nephrogenic systemic fibrosis, venous stasis. DOTAREM dosage: 20 ML, MILLILITER(S), 1; 20, ML MILLILITER(S), 1. During the same period patient was treated with GADOVIST, IOPAMIDOL, MAGNEVIST. Patient recovered.
Dotarem Side Effects Report #5450969-1
Consumer or non-health professional from SWITZERLAND reported DOTAREM problem on Aug 27, 2007. Male patient, 49 years of age, weighting 220.5 lb, was diagnosed with angiogram, nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: cataract, decubitus ulcer, disorientation, epilepsy, femur fracture, foot amputation, groin abscess. DOTAREM dosage: 15 ML, MILLILITRE(S), 1, 1, ; 40, ML MILLILITRE(S), 1, 1. During the same period patient was treated with OMNISCAN. Patient died.
Dotarem Side Effects Report #5472439-7
DOTAREM problem was reported by a Consumer or non-health professional from SWITZERLAND on Sept 19, 2007. Female patient, 45 years of age, was diagnosed with nuclear magnetic resonance imaging and was treated with DOTAREM. After drug was administered, patient experienced the following problems/side effects: nephrogenic systemic fibrosis. DOTAREM dosage: 15, ML MILLILITRE (S), 1, 1, TOTAL INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with OMNISCAN. Patient recovered.