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Ammonul adverse events reported to FDA.

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Summary

FDA Adverse Reports: 12. View All

Ammonul FDA safety alerts: 2008

Reported deaths: 9

Reported hospitalizations: 6

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Often additional risks of using a medication, such as Ammonul, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Ammonul users, Learn more about unwanted side effects & find ways to reduce them. Browse Ammonul Adverse Reports reported to FDA and participate in Ammonul discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Ammonul. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Ammonul Adverse Effect Reports (FDA)

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6821260-3 | Ammonia Increased, Aspartate Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Disseminated Intravascular Coagulation, Epstein-barr Virus Infection, Histiocytosis Haematophagic, Multi-organ Failure, Respiratory Failure, Shock
on Jun 14, 2010 Female patient from SLOVENIA , child 2 years of age, weighting 35.20 lb, was diagnosed with hyperammonaemia and was treated with Ammonul (View Usage). Patient experienced the following unwanted or unexpected effects: ammonia increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, disseminated intravascular coagulation, epstein-barr virus infection, histiocytosis haematophagic, multi-organ failure, respiratory failure, shock. Ammonul dosage: 4000/4000 Mg, Daily,. During the same period patient was treated with DOPAMINE HCL (View Dopamine Hcl Review and Dopamine Hcl Label ), NORADRENALINE (View Noradrenaline Review and Noradrenaline Label ), KETANEST (View Ketanest Review and Ketanest Label ), CEFOTAXIME SODIUM (View Cefotaxime Sodium Review and Cefotaxime Sodium Label ), FLUCLOXACILLIN (View Flucloxacillin Review and Flucloxacillin Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), HAEMOCOMPLETTAN (View Haemocomplettan Review and Haemocomplettan Label ), INSULIN (View Insulin Review and Insulin Label ).

6754964-1 | Ammonia Increased, Apnoea, Cardiac Arrest, Circulatory Collapse, Hypotension, No Therapeutic Response
Patient was taking Ammonul (View Usage). Patient had the following side effects: ammonia increased, apnoea, cardiac arrest (What is cardiac arrest?), circulatory collapse, hypotension, no therapeutic response on May 17, 2010 from TURKEY Additional patient health information: Male patient , weighting 8.82 lb, was diagnosed with hyperammonaemia and. Ammonul dosage: 5 Ml/kg/day, Intravenous. During the same period patient was treated with ^CEFOTOXIN^ (View ^cefotoxin^ Review and ^cefotoxin^ Label ), ^AMICOCYN^ (View ^amicocyn^ Review and ^amicocyn^ Label ), ^NOCYTE SUSPENSION^ (View ^nocyte Suspension^ Review and ^nocyte Suspension^ Label ), ^FORMULA (UCD1) MONA^ AND CARBAGLU (View ^formula (ucd1) Mona^ And Carbaglu Review and ^formula (ucd1) Mona^ And Carbaglu Label ). Patient was hospitalized.

6696073-6 | Ammonia Increased
Adverse event was reported on Dec 07, 2009 by a Female patient taking Ammonul (View Usage) (Dosage: 5,5 G/m^2, Intravenous) . Location: UNITED STATES , 53 years of age, weighting 222.2 lb, After Ammonul was administered, patient had the following side effects: ammonia increased. During the same period patient was treated with LACTULOSE ENEMAS (View Lactulose Enemas Review and Lactulose Enemas Label ), RIFAXIMIN (View Rifaximin Review and Rifaximin Label ), DOCUSATE SODIUM (View Docusate Sodium Review and Docusate Sodium Label ), NEXIUM (View Nexium Review and Nexium Label ), LIDOCAINE (View Lidocaine Review and Lidocaine Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), CELLCEPT (View Cellcept Review and Cellcept Label ), FOLIC ACID (View Folic Acid Review and Folic Acid Label ). Patient was hospitalized.

6472370-4 | Cardiac Disorder, Epilepsy, Nervous System Disorder, No Therapeutic Response, Respiratory Disorder
on Nov 13, 2009 Female patient from TURKEY , weighting 7.05 lb, was diagnosed with hyperglycaemia and was treated with Ammonul (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac disorder, epilepsy (What is epilepsy?), nervous system disorder, no therapeutic response, respiratory disorder. Ammonul dosage: 8 Ml Once, Intravenous. During the same period patient was treated with DEXTROSE 10% (View Dextrose 10% Review and Dextrose 10% Label ), SODIUM (View Sodium Review and Sodium Label ), POTASSIUM (View Potassium Review and Potassium Label ), MIDAZOLAM INFUSION (View Midazolam Infusion Review and Midazolam Infusion Label ), ^CEFOTAXIN^ (View ^cefotaxin^ Review and ^cefotaxin^ Label ), L CARNITINE (View L-carnitine Review and L-carnitine Label ), SODIUM BENZOATE (View Sodium Benzoate Review and Sodium Benzoate Label ). Patient was hospitalized.


6457730-X | Ammonia Increased, Disseminated Intravascular Coagulation, Haemodialysis, Hyperammonaemia, Status Epilepticus
on Nov 09, 2009 Female patient from FRANCE , weighting 7.69 lb, was diagnosed with coma and was treated with Ammonul (View Usage). Patient had the following side effects: ammonia increased, disseminated intravascular coagulation, haemodialysis, hyperammonaemia, status epilepticus. Ammonul dosage: 250 Mg/kg/day, Intravenous. During the same period patient was treated with ARGININE CHLORHYDRATE (View Arginine Chlorhydrate Review and Arginine Chlorhydrate Label ), CEFOTAXIME (View Cefotaxime Review and Cefotaxime Label ), VANCOMYCIN (View Vancomycin Review and Vancomycin Label ), GENTAMICIN (View Gentamicin Review and Gentamicin Label ). Patient was hospitalized.

6398781-3 | Ammonia Decreased, Feeding Disorder, Multi-organ Failure, Renal Impairment
Patient was taking Ammonul (View Usage). After Ammonul was administered, patient had the following side effects: ammonia decreased, feeding disorder, multi-organ failure, renal impairment on Sep 22, 2009 from NETHERLANDS Additional patient health information: Female patient , weighting 4.41 lb, was diagnosed with hyperammonaemia and. Ammonul dosage: Intravenous.

6326329-8 | Agitation, Encephalopathy, Fatigue, Heparin-induced Thrombocytopenia, Hyperplasia, Nausea, Polyp, Pulmonary Arterial Hypertension, Pulmonary Embolism
Adverse event was reported on Aug 06, 2009 by a Female patient taking Ammonul (View Usage) (Dosage: Continuous Infusion, Iv) was diagnosed with ammonia increased, amino acid metabolism disorder and. Location: UNITED STATES , 33 years of age, weighting 125.4 lb, Patient experienced the following unwanted or unexpected effects: agitation, encephalopathy, fatigue, heparin-induced thrombocytopenia, hyperplasia, nausea (What is nausea?), polyp, pulmonary arterial hypertension, pulmonary embolism (What is pulmonary embolism?). During the same period patient was treated with BUPHENYL (6 Grams Every 8 Hours, Oral) (View Buphenyl Review and Buphenyl Label ), VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP (View Vitamin And Mineral Prenatal Supplement W/ Folic Acid Cap Review and Vitamin And Mineral Prenatal Supplement W/ Folic Acid Cap Label ), KEPPRA (View Keppra Review and Keppra Label ). Patient was hospitalized.

6273319-X | Cardiovascular Insufficiency, Hyperammonaemia, Infection, Multi-organ Disorder, Peritoneal Dialysis, Respiratory Failure
on Jul 03, 2009 Male patient from GERMANY , weighting 5.51 lb, was treated with Ammonul (View Usage). Patient had the following side effects: cardiovascular insufficiency, hyperammonaemia, infection (What is infection?), multi-organ disorder, peritoneal dialysis, respiratory failure. Ammonul dosage: .

6096896-0 | Cardio-respiratory Arrest, Cardiovascular Insufficiency, Intestinal Perforation, Laboratory Test Abnormal, Necrotising Colitis, Oxygen Saturation Decreased, Post Procedural Complication, Sepsis
on Feb 10, 2009 Male patient from GERMANY , weighting 6.61 lb, was diagnosed with argininosuccinate synthetase deficiency and was treated with Ammonul (View Usage). After Ammonul was administered, patient had 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 HCL 2% (View Arginine-hcl 2% Review and Arginine-hcl 2% Label ), UCD SOLUTION (View Ucd Solution Review and Ucd Solution Label ), BICARBONATE (View Bicarbonate Review and Bicarbonate Label ), INSULIN + GLUCOSE (View Insulin + Glucose Review and Insulin + Glucose Label ).

5786684-4 | Ammonia Increased, Brain Oedema, Dialysis, Neonatal Disorder
Patient was taking Ammonul (View Usage). Patient experienced the following unwanted or unexpected effects: ammonia increased, brain oedema, dialysis (What is dialysis?), neonatal disorder on Jun 04, 2008 from GERMANY Additional patient health information: Female patient , weighting 6.61 lb, was diagnosed with hyperammonaemia and. Ammonul dosage: . Patient was hospitalized.

5663683-4 | Bone Marrow Failure, Coma, Complications Of Bone Marrow Transplant, Dialysis, Epilepsy, Haemorrhage, Intra-abdominal Haematoma, Respiratory Depression
Adverse event was reported on Feb 25, 2008 by a Female patient taking Ammonul (View Usage) (Dosage: 1 G Daily/intravenously) was diagnosed with hyperammonaemia, prophylaxis and. Location: FRANCE , 19 years of age, Patient had 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. During the same period patient was treated with POSCONAZOLE 400 MG (400 Mg Daily) (View Posconazole 400 Mg Review and Posconazole 400 Mg Label ), NEXIUM (40 Mg Daily) (View Nexium Review and Nexium Label ), AMMONAPS (SODIUM PHENYLBUTYRATE) (View Ammonaps (sodium Phenylbutyrate) Review and Ammonaps (sodium Phenylbutyrate) Label ), TIENAM (IMIPENEM/CILASTATIN) (View Tienam (imipenem/cilastatin) Review and Tienam (imipenem/cilastatin) Label ), ORGARAN (DANAPROID) (View Orgaran (danaproid) Review and Orgaran (danaproid) Label ), LEVOCARNIL (L CARTNTINE) (View Levocarnil (l-cartntine) Review and Levocarnil (l-cartntine) Label ), ARGININE (View Arginine Review and Arginine Label ), MORPHINE (View Morphine Review and Morphine Label ).

5603346-4 | Aplasia, Coma, Haemorrhage, Sepsis, Thrombocytopenia
on Jan 09, 2008 Female patient from FRANCE , 19 years of age, weighting 121.3 lb, was diagnosed with hyperammonaemia, prophylaxis and was treated with Ammonul (View Usage). After Ammonul was administered, patient had the following side effects: aplasia, coma, haemorrhage, sepsis (What is sepsis?), thrombocytopenia. Ammonul dosage: 1 G Daily. During the same period patient was treated with POSOCONAZOLE (400 Mg) (View Posoconazole Review and Posoconazole Label ), NEXIUM (40 Mg) (View Nexium Review and Nexium Label ), TIENAM (IMIPENEM AND CILASTATIN SODIUM) (View Tienam (imipenem And Cilastatin Sodium) Review and Tienam (imipenem And Cilastatin Sodium) Label ), ORGARAN (DANAPROID) (View Orgaran (danaproid) Review and Orgaran (danaproid) Label ), LEVOCARNIL (L CARNITINE) (View Levocarnil (l-carnitine) Review and Levocarnil (l-carnitine) Label ), ARGININE (View Arginine Review and Arginine Label ).


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Ammonul risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Ammonul quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Ammonul use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Ammonul Reactions
Agitation
Ammonia Decreased
Ammonia Increased
Aplasia
Apnoea
Aspartate Aminotransferase Increased
Blood Lactate Dehydrogenase Increased
Bone Marrow Failure
Brain Oedema
Cardiac ArrestWhat is Cardiac arrest?
Cardiac Disorder
Cardio-respiratory Arrest
Cardiovascular Insufficiency
Circulatory Collapse
Coma
Complications Of Bone Marrow Transplant
DialysisWhat is Dialysis?
Disseminated Intravascular Coagulation
Encephalopathy
EpilepsyWhat is Epilepsy?
Epstein-barr Virus Infection
Fatigue
Feeding Disorder
Haemodialysis
Haemorrhage
Hyperammonaemia
Multi-organ Failure
No Therapeutic Response
Respiratory Failure
SepsisWhat is Sepsis?
Ammonul Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Ammonul adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!