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Review Alprostadil Safety Reports submitted to FDA

Total Alprostadil reports: 29.
Alprostadil FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 13.
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FDA Reported Alprostadil Side Effects: infantile apnoeic attack, pyrexia, condition aggravated, cardiac failure congestive, pulmonary oedema, renal failure acute, gastrointestinal haemorrhage, cardiac failure acute, chills, sepsis, body temperature increased.
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Alprostadil Side Effects Report #5657955-7
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Dec 21, 2007. Male patient, 66 years of age, was diagnosed with arteriovenous shunt operation, hepatic function abnormal and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: arthralgia, gait disturbance, hepatic function abnormal, muscle spasms. ALPROSTADIL dosage: unknown. During the same period patient was treated with CEFAZOLIN, CHARCOAL, FUROSEMIDE, LAFUTIDINE, ALFACALCIDOL, AMLODIPINE BESYLATE. Patient recovered.

Alprostadil Side Effects Report #5678348-2
ALPROSTADIL problem was reported by a Consumer or non-health professional from GERMANY on Feb 15, 2008. Male patient, 62 years of age, was diagnosed with frostbite and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: neuropathic arthropathy. ALPROSTADIL dosage: unknown. During the same period patient was treated with CHLORIDE, HEPARIN. Patient recovered.

Alprostadil Side Effects Report #5682743-5
Pharmacist from UNITED STATES reported ALPROSTADIL problem on Mar 26, 2008. Male patient, 65 years of age, weighting 206.4 lb, was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: priapism. ALPROSTADIL dosage: unknown. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5616526-9
ALPROSTADIL problem was reported by a Consumer or non-health professional from JAPAN on Jan 19, 2008. Female patient, 61 years of age, was diagnosed with arterial occlusive disease and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: subarachnoid haemorrhage. ALPROSTADIL dosage: unknown. During the same period patient was treated with ABBOKINASE. Patient died.

Alprostadil Side Effects Report #5622000-6
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Dec 21, 2007. Female patient, 66 years of age, was diagnosed with vascular shunt and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: arthralgia, c-reactive protein increased, gait disturbance, muscle spasms. ALPROSTADIL dosage: unknown. During the same period patient was treated with CEFAZOLIN, CHARCOAL, FUROSEMIDE, LAFUTIDINE, ALFACALCIDOL, AMLODIPINE BESYLATE. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5632022-7
ALPROSTADIL problem was reported by a Consumer or non-health professional from JAPAN on Jan 19, 2008. Female patient, 61 years of age, was diagnosed with arterial occlusive disease and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: subarachnoid haemorrhage. ALPROSTADIL dosage: unknown. During the same period patient was treated with ABBOKINASE. Patient died.

Alprostadil Side Effects Report #5642004-7
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Dec 21, 2007. Male patient, 66 years of age, was diagnosed with postoperative care and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: arthralgia, c-reactive protein increased, gait disturbance, muscle spasms, pain in extremity, renal failure chronic, white blood cell count increased. ALPROSTADIL dosage: unknown. During the same period patient was treated with CEFAZOLIN, CHARCOAL, FUROSEMIDE, LAFUTIDINE, ALFACALCIDOL, AMLODIPINE BESYLATE. Patient recovered.

Alprostadil Side Effects Report #5584759-6
ALPROSTADIL problem was reported by a Consumer or non-health professional from JAPAN on Dec 05, 2007. Female patient, 28 years of age, was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: haemodialysis, haemolytic anaemia, haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura. ALPROSTADIL dosage: 500 MCG INTRAVENOUS DRIP, 60 MCG INTRAVENOUS DRIP, 2 MG INTRAVENOUS DRIP. During the same period patient was treated with GABEXATE MESILATE, TACROLIMUS, MYCOPHENOLATE MOFETIL, MARVELON. Patient recovered.

Alprostadil Side Effects Report #5586141-4
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Dec 21, 2007. Male patient, 66 years of age, was diagnosed with postoperative care and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: pain in extremity. ALPROSTADIL dosage: unknown. During the same period patient was treated with CEFAZOLIN, CHARCOAL, FUROSEMIDE, LAFUTIDINE, ALFACALCIDOL, AMLODIPINE BESYLATE. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5591148-7
ALPROSTADIL problem was reported by a Consumer or non-health professional from JAPAN on Dec 25, 2007. Male patient, 35 years of age, was diagnosed with skin operation and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: necrosis, venipuncture site thrombosis, vessel puncture site haematoma. ALPROSTADIL dosage: unknown. During the same period patient was treated with HEPARIN, ABBOKINASE. Patient recovered.

Alprostadil Side Effects Report #5596713-9
Consumer or non-health professional from UNITED STATES reported ALPROSTADIL problem on Jan 09, 2008. Male patient, 21 years of age, was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, respiratory arrest. ALPROSTADIL dosage: unknown. During the same period patient was treated with ISOFLURANE, SUCCINYLCHOLINE CHLORIDE, NITRIC OXIDE, PROPOFOL, FENTANYL, PAPAVERINE. Patient died on 01/01/2006.

Alprostadil Side Effects Report #5575904-7
ALPROSTADIL problem was reported by a Consumer or non-health professional from JAPAN on Dec 05, 2007. Female patient, 28 years of age, was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura. ALPROSTADIL dosage: unknown. During the same period patient was treated with GABEXATE MESILATE, TACROLIMUS, MYCOPHENOLATE MOFETIL, MARVELON. Patient recovered.

Alprostadil Side Effects Report #5581249-1
Consumer or non-health professional from GERMANY reported ALPROSTADIL problem on Dec 14, 2007. Male patient was diagnosed with heart disease congenital and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: cardiac murmur, congenital pulmonary valve atresia, neonatal respiratory distress syndrome, obstruction gastric, vomiting projectile. ALPROSTADIL dosage: unknown. Patient recovered.

Alprostadil Side Effects Report #5506016-6
ALPROSTADIL problem was reported by a Consumer or non-health professional from JAPAN on Oct 15, 2007. Male patient, 75 years of age, was diagnosed with diabetic gangrene and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: pleural effusion, pulmonary oedema. ALPROSTADIL dosage: unknown. During the same period patient was treated with CEFAZOLIN, VANCOMYCIN, MAGNESIUM OXIDE HEAVY, ETODOLAC, SERAPEPTASE, BERAPROST, BICALUTAMIDE, NEO MINOPHAGEN. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5512829-7
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Oct 23, 2007. Male patient, 81 years of age, was diagnosed with arterial occlusive disease and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: erythema, nail dystrophy, psoriatic arthropathy, pustular psoriasis, skin lesion, swelling, therapeutic response decreased. ALPROSTADIL dosage: unknown. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5518116-5
ALPROSTADIL problem was reported by a Consumer or non-health professional from GERMANY on July 24, 2007. Female patient was diagnosed with peripheral arterial occlusive disease and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: chills, inflammation, pyrexia. ALPROSTADIL dosage: unknown. Patient recovered.

Alprostadil Side Effects Report #5519544-4
Consumer or non-health professional from POLAND reported ALPROSTADIL problem on Oct 26, 2007. Female patient, 71 years of age, was diagnosed with peripheral ischaemia and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: anxiety, chest pain, dyspnoea, feeling abnormal, palpitations. ALPROSTADIL dosage: 60 MCG (60 MG 1 IN 1 DAY(S)) INTRAVENOUS DRIP. During the same period patient was treated with GENTAMICIN, DOLARGAN, POLFILIN, SADAMIN, ENOXAPARIN, MIXTARD. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5504509-9
ALPROSTADIL problem was reported by a Consumer or non-health professional from JAPAN on Oct 15, 2007. Male patient, 75 years of age, was diagnosed with diabetic gangrene and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: pulmonary oedema. ALPROSTADIL dosage: unknown. During the same period patient was treated with CEFAZOLIN, VANCOMYCIN. Patient recovered.

Alprostadil Side Effects Report #5449619-X
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Aug 23, 2007. Male patient, 63 years of age, was diagnosed with ischaemic ulcer and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: respiratory arrest, ulcer haemorrhage. ALPROSTADIL dosage: unknown. During the same period patient was treated with ASPIRIN, ALUMINIUM GLYCINATE, MAGNESIUM CARBONATE. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5451806-1
ALPROSTADIL problem was reported by a Consumer or non-health professional from GERMANY on Aug 02, 2007. Female patient, 86 years of age, was diagnosed with peripheral ischaemia, dry gangrene and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: aneurysm, post procedural haematoma. ALPROSTADIL dosage: unknown. During the same period patient was treated with RINGERSECTION IN PLASTIC CONTAINER, ACETYLSALICYLIC ACID SRT, ACETYLSALICYLIC ACID SRT, CLOPIDOGREL BISULPHATE, CLOPIDOGREL BISULPHATE, ENOXAPARIN, HEPARIN, INSULIN. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5466972-1
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Aug 23, 2007. Male patient, 65 years of age, was diagnosed with skin ulcer, atrial fibrillation and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: arrhythmia, atrial fibrillation, gait disturbance, gastrointestinal haemorrhage, haematemesis, pneumonia, respiratory arrest, shock haemorrhagic. ALPROSTADIL dosage: unknown. During the same period patient was treated with ACETYLSALICYLIC ACID SRT, UNASYN, FLOMOXEF, FAMOTIDINE. Patient recovered.

Alprostadil Side Effects Report #5467870-X
ALPROSTADIL problem was reported by a Health Professional from UKRAINE on June 14, 2006. Male patient, 66 years of age, was diagnosed with peripheral ischaemia and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage. ALPROSTADIL dosage: unknown. During the same period patient was treated with GLIBANCLAMIDE. Patient recovered.

Alprostadil Side Effects Report #5412703-0
Consumer or non-health professional from GERMANY reported ALPROSTADIL problem on July 24, 2007. Female patient was diagnosed with peripheral arterial occlusive disease and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: chills, inflammation, pyrexia, sepsis. ALPROSTADIL dosage: unknown. Patient recovered.

Alprostadil Side Effects Report #5427624-7
ALPROSTADIL problem was reported by a Consumer or non-health professional from GERMANY on Aug 02, 2007. Female patient, 86 years of age, was diagnosed with peripheral ischaemia, dry gangrene and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: aneurysm, haematoma, post procedural complication. ALPROSTADIL dosage: unknown. During the same period patient was treated with RINGERSECTION IN PLASTIC CONTAINER, ACETYLSALICYLIC ACID SRT, ACETYLSALICYLIC ACID SRT, CLOPIDOGREL BISULPHATE, ENOXAPARIN, HEPARIN, INSULIN, NEUROTRAT. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5427635-1
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Aug 09, 2007. Male patient, 75 years of age, was diagnosed with arteriosclerosis obliterans and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: cardiac failure acute. ALPROSTADIL dosage: unknown. Patient recovered.

Alprostadil Side Effects Report #5387250-5
ALPROSTADIL problem was reported by a Consumer or non-health professional from GERMANY on May 03, 2007. Female patient was diagnosed with peripheral arterial occlusive disease and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: left ventricular failure, pulmonary oedema. ALPROSTADIL dosage: unknown. During the same period patient was treated with CHLORIDE. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5393100-3
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Apr 27, 2007. Female patient, 83 years of age, was diagnosed with arteriosclerosis obliterans, spinal osteoarthritis, mental disorder and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, apathy, back pain, epidermolysis, muscular weakness, neck pain, pain in extremity, pruritus. ALPROSTADIL dosage: unknown. During the same period patient was treated with CLONAZEPAM, NOLPORT, KASHIWADOL, ETIZOLAM, FUROSEMIDE, SPIRONOLACTONE, TOCOPHERYL NICOTINATE, SENNOSIDE. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5387250-5
ALPROSTADIL problem was reported by a Consumer or non-health professional from GERMANY on May 03, 2007. Female patient was diagnosed with peripheral arterial occlusive disease and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: left ventricular failure, pulmonary oedema. ALPROSTADIL dosage: unknown. During the same period patient was treated with CHLORIDE. Patient was hospitalized. Patient recovered.

Alprostadil Side Effects Report #5393100-3
Consumer or non-health professional from JAPAN reported ALPROSTADIL problem on Apr 27, 2007. Female patient, 83 years of age, was diagnosed with arteriosclerosis obliterans, spinal osteoarthritis, mental disorder and was treated with ALPROSTADIL. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, apathy, back pain, epidermolysis, muscular weakness, neck pain, pain in extremity, pruritus. ALPROSTADIL dosage: unknown. During the same period patient was treated with CLONAZEPAM, NOLPORT, KASHIWADOL, ETIZOLAM, FUROSEMIDE, SPIRONOLACTONE, TOCOPHERYL NICOTINATE, SENNOSIDE. Patient was hospitalized. Patient recovered.


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arthralgia, gait disturbance, hepatic function abnormal, muscle spasms, neuropathic arthropathy, priapism, , was diagnosed with arteriovenous shunt operation, hepatic function abnormal and was diagnosed with frostbite and