About this FactMed analysis covering adverse side effect reports of ADDAMEL patients who developed HYPERAMMONAEMIA.

FactMed provides MD-approved analysis to help both patients, researchers, and physicians accurately assess the risk profile for more than 20,000 different pharmaceutical products. The below report offers compiled information from Food & Drug Administration and FactMed user submissions. Between January 2004 and October 2012, 1 individuals taking ADDAMEL reported HYPERAMMONAEMIA to the FDA. A total of 12 ADDAMEL drug adverse event reaction reports were made with the FDA during this time period. Often the FDA only receives reports of the most critical and severe cases; these numbers may therefore underrepresent the complication rate of the medication.

FDA Research Report

Introduction This page is designed to help you determine the relationship, if any, between ADDAMEL and HYPERAMMONAEMIA. In doing so, we compare ADDAMEL with other drugs that cause HYPERAMMONAEMIA, to help you evaluate whether or not ADDAMEL causes HYPERAMMONAEMIA. Likewise, this page shows the most highly-reported side effects of ADDAMEL, so you can see if HYPERAMMONAEMIA ranks among ADDAMEL's most well-known side effects.
Summary Statistics
Reports of ADDAMEL causing HYPERAMMONAEMIA: 1
Reports of any side effect of ADDAMEL : 12
Percentage of ADDAMEL patients where HYPERAMMONAEMIA is a reported side effect: 8.3333%

FDA reports of any drug causing HYPERAMMONAEMIA : 1434
Average percentage for all medicated patients where HYPERAMMONAEMIA is reported as a complication: 0.0090%

Physician opinion on ADDAMEL as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing ADDAMEL:
DRUG USE FOR UNKNOWN INDICATION ( 3 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 1 patients )
VITAMIN SUPPLEMENTATION ( 1 patients )
PROPHYLAXIS ( 1 patients )
( 0 patients )
Drugs with high FDA adverse event association with HYPERAMMONAEMIA:

FLUOROURACIL (209 patients)
DEPAKENE (166 patients)
TOPIRAMATE (166 patients)
DEPAKOTE (148 patients)
VALPROATE SODIUM (132 patients)
VALPROIC ACID (123 patients)
NEXAVAR (115 patients)
OXALIPLATIN (106 patients)
LASIX (82 patients)
AVASTIN (69 patients)
ASPIRIN (62 patients)
TEGRETOL (58 patients)
CARBAMAZEPINE (58 patients)
FUROSEMIDE (54 patients)
OMEPRAZOLE (53 patients)
LEUCOVORIN CALCIUM (53 patients)
FAMOTIDINE (51 patients)
METHOTREXATE (49 patients)
ALDACTONE (48 patients)
LACTULOSE (47 patients)
XELODA (46 patients)
CLONAZEPAM (45 patients)
URSO 250 (45 patients)
PHENOBARBITAL TAB (43 patients)
KEPPRA (41 patients)
LAMOTRIGINE (39 patients)
ACETAMINOPHEN (36 patients)
RISPERIDONE (35 patients)
ELPLAT (33 patients)
PREDNISOLONE (31 patients)
DEXAMETHASONE (31 patients)
LIVACT (30 patients)
DECADRON (30 patients)
HALOPERIDOL (27 patients)
SPIRONOLACTONE (27 patients)
MAGNESIUM OXIDE (26 patients)
TACROLIMUS (25 patients)
LORAZEPAM (25 patients)
IRINOTECAN HCL (25 patients)
RABEPRAZOLE SODIUM (25 patients)
CALCIUM LEVOFOLINATE (24 patients)
EXJADE (24 patients)
SOLU-MEDROL (24 patients)
TOPINA (24 patients)
OLANZAPINE (23 patients)
LEVOLEUCOVORIN CALCIUM (23 patients)
CYMBALTA (23 patients)
ATENOLOL (23 patients)
VELCADE (23 patients)
LITHIUM CARBONATE (22 patients)
CYTARABINE (22 patients)
DEPAKOTE ER (22 patients)
TOPAMAX (22 patients)
LANSOPRAZOLE (22 patients)
GLEEVEC (22 patients)
5-FU (21 patients)
PARACETAMOL (21 patients)
NORVASC (21 patients)
IBUPROFEN (20 patients)
NEURONTIN (20 patients)
SEROQUEL (20 patients)
CISPLATIN (20 patients)
RISPERDAL (20 patients)
PROGRAF (20 patients)
CITALOPRAM HYDROBROMIDE (20 patients)
NEORAL (20 patients)
LEVOTHYROXINE SODIUM (20 patients)
DIVALPROEX SODIUM (19 patients)
VINCRISTINE (19 patients)
WARFARIN SODIUM (19 patients)
ZONISAMIDE (19 patients)
LAMICTAL (19 patients)
KYTRIL (19 patients)
OXYCONTIN (18 patients)
INSULIN (18 patients)
VOLTAREN (18 patients)
TRILEPTAL (18 patients)
METFORMIN HCL (18 patients)
AMLODIPINE (18 patients)
PHENYTOIN (18 patients)
ATARAX (18 patients)
GASTER D (18 patients)
OXAZEPAM (18 patients)
MYSTAN (17 patients)
CLOBAZAM (17 patients)
MIDAZOLAM HCL (17 patients)
ZYPREXA (17 patients)
CYCLOPHOSPHAMIDE (17 patients)
MULTI-VITAMINS (17 patients)
PEG-INTERFERON A-2A (RO 25-8310) (17 patients)
ENALAPRIL MALEATE (16 patients)
FLUCONAZOLE (16 patients)
ACYCLOVIR (16 patients)
RIVOTRIL (16 patients)
PAROXETINE HCL (16 patients)
MUCOSTA (16 patients)
ARICEPT (16 patients)
GASTER (16 patients)
PURSENNID (15 patients)
PLAVIX (15 patients)
DIAZEPAM (15 patients)
GRANISETRON HYDROCHLORIDE (15 patients)
PREDNISONE (15 patients)
TARGOCID (15 patients)
LOXONIN (15 patients)
METHYLPREDNISOLONE (14 patients)
EPILIM (14 patients)
PEGASYS (14 patients)
LOXOPROFEN (14 patients)
MYCOPHENOLATE MOFETIL (CELLCEPT) (14 patients)
THYMOGLOBULIN (14 patients)
GABAPENTIN (14 patients)
ACETYLSALICYLIC ACID SRT (13 patients)
QUETIAPINE FUMARATE (13 patients)
TAKEPRON (13 patients)
NEXIUM (13 patients)
ALPRAZOLAM (13 patients)
PANITUMUMAB (13 patients)
AMPHOTERICIN B (13 patients)
ATORVASTATIN (13 patients)
FLUDARA (13 patients)
URSODIOL (13 patients)
BARACLUDE (13 patients)
TOPOTECAN (12 patients)
URBANYL (12 patients)
BETAMETHASONE (12 patients)
FOLINIC ACID (12 patients)
DEXAMETHASONE SODIUM PHOSPHATE (12 patients)
TRAZODONE HCL (12 patients)
PARIET (12 patients)
VANCOMYCIN (12 patients)
EMEND (12 patients)
AMOXICILLIN (12 patients)
REBETOL (12 patients)
CYCLOSPORINE (12 patients)
MORPHINE (12 patients)
TEICOPLANIN (12 patients)
ZOLOFT (11 patients)
DIPYRIDAMOLE (11 patients)
PEG-INTRON (11 patients)
LIPITOR (11 patients)
GLYCYRON (11 patients)
CLONIDINE (11 patients)
VFEND (11 patients)
ALLOPURINOL (11 patients)
METHYCOBAL (MECOBALAMIN) (11 patients)
TIAPRIDE (11 patients)
LEVETIRACETAM (11 patients)
LISINOPRIL (11 patients)
ABILIFY (10 patients)
MINOCYCLINE HCL (10 patients)
LANTUS (10 patients)
MYCOPHENOLATE MOFETIL (10 patients)
AMBISOME (10 patients)
MONILAC (10 patients)
EFUDEX (10 patients)
DIOVAN (10 patients)
QUETIAPINE (10 patients)
CINAL (10 patients)
SUNITINIB MALATE (10 patients)
SERTRALINE HYDROCHLORIDE (10 patients)
ZANTAC (10 patients)
VORICONAZOLE (10 patients)
PHENYTOIN SODIUM CAP (10 patients)
BUMETANIDE (10 patients)
TRAMADOL HCL (10 patients)
MIDAZOLAM (10 patients)
ISOVORIN (9 patients)
PHENOBARBITAL (9 patients)
RIBAVIRIN (9 patients)
ZERIT (9 patients)
KETOPROFEN (9 patients)
CLOZAPINE (9 patients)
GLIVEC (9 patients)
BUPHENYL (9 patients)
SUTENT (9 patients)
ALOXI (9 patients)
CARBOPLATIN (9 patients)
AMINOLEBAN EN (9 patients)
DOXORUBICIN HCL (9 patients)
AMITRIPTYLINE HCL (9 patients)
VINORELBINE (9 patients)
PROPOFOL (9 patients)
SELBEX (9 patients)
ARGININE (9 patients)
FLUOXETINE (9 patients)
KLONOPIN (9 patients)
LENDORMIN (9 patients)
XANAX (9 patients)
PRIMPERAN TAB (9 patients)
PROPRANOLOL (9 patients)
NOVOSEVEN (9 patients)
NIFEDIPINE (9 patients)
RIBAVIRIN (NON-ROCHE) (8 patients)
FLURAZEPAM (8 patients)
ACTOS (8 patients)
PENTAZOCINE LACTATE (8 patients)
DEXAMETHASONE TAB (8 patients)
AMARYL (8 patients)
AMBIEN (8 patients)
FUNGIZONE (8 patients)
GLICLAZIDE (8 patients)
FENTANYL-100 (8 patients)
POTASSIUM CHLORIDE (8 patients)
FLUDARABINE PHOSPHATE (8 patients)
FOLIC ACID (8 patients)
ATORVASTATIN CALCIUM (8 patients)
PRODIF (8 patients)
BACTRIM (8 patients)
INVEGA (8 patients)

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