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 43%
Haemorrhage 43%
Ammonia increased 29%
Bone marrow failure 29%
Complications of bone marrow transplant 29%
Dialysis  What is  Dialysis                                                                                                                                                                                                29%
Disease progression 29%
Epilepsy  What is  Epilepsy                                                                                                                                                                                                29%
Multi-organ failure 29%
Sepsis  What is  Sepsis                                                                                                                                                                                                  29%
Shock 29%
Aplasia 14%
Brain oedema 14%
Cardio-respiratory arrest 14%
Cardiovascular insufficiency 14%
Gastric disorder 14%
Haematoma 14%
Hyperammonaemia 14%
Intestinal perforation 14%
Intra-abdominal haematoma 14%
Laboratory test abnormal 14%
Necrotising colitis 14%
Neonatal disorder 14%
No therapeutic response 14%
Oxygen saturation decreased 14%
Post procedural complication 14%
Respiratory depression 14%
Thrombocytopenia 14%

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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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