Ammonul Side Effects summary

Total Ammonul reports: 7. View

Ammonul FDA safety alerts: 2008 .

Reported deaths: 6

Reported hospitalizations: 1.

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Recently reported Ammonul Side Effects


Common Ammonul Side Effects
Coma 3
Haemorrhage 3
Ammonia increased 2
Bone marrow failure 2
Complications of bone marrow transplant 2
Dialysis  What is  Dialysis                                                                                                                                                                                                2
Disease progression 2
Epilepsy  What is  Epilepsy                                                                                                                                                                                                2
Multi-organ failure 2
Sepsis  What is  Sepsis                                                                                                                                                                                                  2
Shock 2
Aplasia 1
Brain oedema 1
Cardio-respiratory arrest 1
Cardiovascular insufficiency 1
Gastric disorder 1
Haematoma 1
Hyperammonaemia 1
Intestinal perforation 1
Intra-abdominal haematoma 1
Laboratory test abnormal 1
Necrotising colitis 1
Neonatal disorder 1
No therapeutic response 1
Oxygen saturation decreased 1
Post procedural complication 1
Respiratory depression 1
Thrombocytopenia 1

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Ammonul Side Effects reported on Patientsville.com

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Ammonul Side Effects reported to FDA

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Ammonul Side Effects Report #5472548-2
Physician from FRANCE reported Ammonul side effect on Sept 11, 2007. Male patient was diagnosed with amino acid metabolism disorder and was treated with Ammonul. After drug was administered, patient experienced the following side effects: ammonia increased, disease progression, multi-organ failure, no therapeutic response, shock. Ammonul dosage: 5 ML/24 HOURS/IV. Patient died on 09/16/2007.



Ammonul Side Effects Report #5491329-7
Ammonul side effect was reported by a Physician from FRANCE on Oct 04, 2007. Male patient was diagnosed with amino acid metabolism disorder and was treated with Ammonul. After drug was administered, patient experienced the following side effects: disease progression, multi-organ failure, shock. Ammonul dosage: 5 ML/24 HOURS /IV; 2.5 ML/24 HOURS/IV. Patient died on 09/16/2007.



Ammonul Side Effects Report #5603346-4
Physician from FRANCE reported Ammonul side effect on Jan 09, 2008. Female patient, 19 years of age, weighting 121.3 lb, was diagnosed with hyperammonaemia, prophylaxis and was treated with Ammonul. After drug was administered, patient experienced the following side effects: aplasia, coma, haemorrhage, sepsis What is  sepsis, thrombocytopenia. Ammonul dosage: unknown. During the same period patient was treated with POSOCONAZOLE, NEXIUM, TIENAM, ORGARAN, LEVOCARNIL, ARGININE. Patient recovered.



Ammonul Side Effects Report #5622930-5
Ammonul side effect was reported by a Physician from FRANCE on Jan 22, 2008. Female patient, 19 years of age, weighting 121.3 lb, was diagnosed with hyperammonaemia, prophylaxis and was treated with Ammonul. After drug was administered, patient experienced the following side effects: bone marrow failure, coma, complications of bone marrow transplant, epilepsy What is  epilepsy, gastric disorder, haematoma, haemorrhage, hyperammonaemia. Ammonul dosage: unknown. During the same period patient was treated with POSOCONAZOLE, NEXIUM, AMMONAPS, TIENAM, ORGARAN, LEVOCARNIL, ARGININE, MORPHINE. Patient died on 01/24/2008.




Ammonul Side Effects Report #5663683-4
Physician from FRANCE reported Ammonul side effect on Feb 25, 2008. Female patient, 19 years of age, was diagnosed with hyperammonaemia, prophylaxis and was treated with Ammonul. After drug was administered, patient experienced the following side effects: bone marrow failure, coma, complications of bone marrow transplant, dialysis What is  dialysis, epilepsy What is  epilepsy, haemorrhage, intra-abdominal haematoma, respiratory depression. Ammonul dosage: unknown. During the same period patient was treated with POSCONAZOLE, NEXIUM, AMMONAPS, TIENAM, ORGARAN, LEVOCARNIL, ARGININE, MORPHINE. Patient died on 01/24/2008.



Ammonul Side Effects Report #5786684-4
Ammonul side effect was reported by a Physician from GERMANY on June 04, 2008. Female patient, weighting 6.61 lb, was diagnosed with hyperammonaemia and was treated with Ammonul. After drug was administered, patient experienced the following side effects: ammonia increased, brain oedema, dialysis What is  dialysis, neonatal disorder. Ammonul dosage: unknown. Patient was hospitalized. Patient died.



Ammonul Side Effects Report #6096896-0
Physician from GERMANY reported Ammonul side effect on Feb 10, 2009. Male patient, weighting 6.61 lb, was diagnosed with argininosuccinate synthetase deficiency and was treated with Ammonul. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, cardiovascular insufficiency, intestinal perforation, laboratory test abnormal, necrotising colitis, oxygen saturation decreased, post procedural complication, sepsis What is  sepsis. Ammonul dosage: 1ST DAY 16 ML THEN 8 ML. During the same period patient was treated with ARGININE, UCD SOLUTION, BICARBONATE, INSULIN. Patient died on 12/12/2008.





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