Common Aminoleban Side Effects


The most commonly reported Aminoleban side effects (click to view or check a box to report):

Decreased Appetite (3)
Hepatic Failure (3)
Hepatic Encephalopathy (3)
Ascites (2)
Aspartate Aminotransferase Increased (2)
Dyspnoea (2)
Liver Disorder (2)
Pneumonia Aspiration (2)
Haemorrhagic Ascites (2)
Palmar-plantar Erythrodysaesthesia Syndrome (1)
Platelet Count Decreased (1)
Pulmonary Oedema (1)
Nausea (1)
Pleural Effusion (1)
Muscular Weakness (1)
Metastases To Peritoneum (1)
Metabolic Acidosis (1)
Lymphocyte Stimulation Test Positive (1)
Liver Carcinoma Ruptured (1)
Liver Abscess (1)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Aminoleban Side Effects Reported to FDA



Aminoleban Side Effect Report#8397731-8
Infection, Renal Failure Acute, Acute Hepatic Failure, Disseminated Intravascular Coagulation, Pulmonary Oedema, Platelet Count Decreased, Pyrexia, Liver Abscess
This is a report of a 62-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Aminoleban En (dosage: Daily Dose 50 G, start time:
Feb 09, 2011), combined with: NA. and developed a serious reaction and side effect(s): Infection, Renal Failure Acute, Acute Hepatic Failure, Disseminated Intravascular Coagulation, Pulmonary Oedema, Platelet Count Decreased, Pyrexia, Liver Abscess after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aminoleban En treatment in male patients, resulting in Infection side effect. The patient was hospitalized.
Aminoleban Side Effect Report#8173998-6
Palmar-plantar Erythrodysaesthesia Syndrome, Hepatic Function Abnormal, Hepatic Failure, Pleural Effusion, Ascites
This report suggests a potential Aminoleban En Palmar-plantar Erythrodysaesthesia Syndrome side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Aminoleban En (dosage: Daily Dose 50 G) starting
Aug 11, 2011. After starting Aminoleban En the patient began experiencing various side effects, including: Palmar-plantar Erythrodysaesthesia Syndrome, Hepatic Function Abnormal, Hepatic Failure, Pleural Effusion, AscitesAdditional drugs used concurrently:
  • Miya Bm (Daily Dose 3 G)
  • Nexavar (200 Mg, Qd)
  • Zantac (Daily Dose 300 Mg)
  • Lasix (Daily Dose 20 Mg)
  • Nexavar (400 Mg, Qd)
  • Alendronate Sodium (Daily Dose 35 Mg)
  • Urso 250 (Daily Dose 600 Mg)
  • Livact (Daily Dose 12.45 G)
The patient was hospitalized. Although Aminoleban En demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Palmar-plantar Erythrodysaesthesia Syndrome, may still occur.
Aminoleban Side Effect Report#7991893-X
Nausea, Aspartate Aminotransferase Increased, Dyspnoea, Liver Disorder, Hepatic Failure, Flushing, Pneumonia Aspiration, Decreased Appetite
This Nausea problem was reported by a pharmacist from Japan. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 31, 2011 this consumer started treatment with Aminoleban En (dosage: 150 G, Unk). The following drugs were being taken at the same time:
  • Neoral (200 Mg)
When using Aminoleban En, the patient experienced the following unwanted symptoms/side effects: Nausea, Aspartate Aminotransferase Increased, Dyspnoea, Liver Disorder, Hepatic Failure, Flushing, Pneumonia Aspiration, Decreased AppetiteAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Aminoleban Side Effect Report#7967819-1
Hepatitis, Lymphocyte Stimulation Test Positive
This Hepatitis side effect was reported by a health professional from Japan. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aminoleban En (alanine, Aminoacetic Acid, Arginine Hydrochloride, Isol (drug dosage: NA), which was initiated on
Mar 31, 2011. Concurrently used drugs:
  • Spironolactone
  • Ursodiol (600 Mg, Qd, Oral)
  • Rabeprazole Sodium
  • Livact /00847901/ (isoleucine, Leucine, Valine)
  • Lebenin (lactobacillus Acidophilus, Lactobacillus Bifidus, Lyophilized (3 Df, Qd, Oral)
.After starting to take Aminoleban En (alanine, Aminoacetic Acid, Arginine Hydrochloride, Isol the consumer reported adverse symptoms, such as: Hepatitis, Lymphocyte Stimulation Test PositiveThese side effects may potentially be related to Aminoleban En (alanine, Aminoacetic Acid, Arginine Hydrochloride, Isol.
Aminoleban Side Effect Report#7940789-8
Liver Carcinoma Ruptured, Haemorrhagic Ascites
This is a report of a 79-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: hepatic neoplasm malignant,insomnia,gastritis prophylaxis,hypertension,muscle spasms, who was treated with Aminoleban En (dosage: 50 Mg, 1x/day, start time:
Nov 04, 2011), combined with:
  • Halcion (0.25 Mg, 1x/day)
  • Rabeprazole Sodium (10 Mg, 1x/day)
  • Aldactone
  • Shakuyakukanzoutou (5 G, 2x/day)
  • Celecoxib (Unk)
  • Pursennid (24 Mg, 1x/day)
  • Livact (3 Df, 3x/day)
  • Lactulose (As Needed, 3x/day)
and developed a serious reaction and side effect(s): Liver Carcinoma Ruptured, Haemorrhagic Ascites after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aminoleban En treatment in female patients, resulting in Liver Carcinoma Ruptured side effect. The patient was hospitalized.
Aminoleban Side Effect Report#7913936-1
Haemorrhagic Ascites, Metastases To Peritoneum
This report suggests a potential Aminoleban En Haemorrhagic Ascites side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: hepatic neoplasm malignant and used Aminoleban En (dosage: 50 Mg, 1x/day) starting
Mar 22, 2011. After starting Aminoleban En the patient began experiencing various side effects, including: Haemorrhagic Ascites, Metastases To PeritoneumAdditional drugs used concurrently:
  • Livact (3 Df, 3x/day)
  • Epirubicin Hydrochloride (60mg)
  • Shakuyakukanzoutou (5 G, 2x/day)
  • Rabeprazole Sodium (10 Mg, 1x/day)
  • Lactulose (As Needed, 3x/day)
  • Taurine (2.04 G, 2x/day)
  • Aldactone
  • Pursennid (24 Mg, 1x/day)
The patient was hospitalized. Although Aminoleban En demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemorrhagic Ascites, may still occur.
Aminoleban Side Effect Report#7846773-7
Dyspnoea, Constipation, Hepatic Failure, Decreased Appetite, Ascites, Chest Pain, Pneumonia Aspiration, Liver Disorder, Aspartate Aminotransferase Increased
This Dyspnoea problem was reported by a pharmacist from Japan. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hepatic failure. On
Aug 31, 2011 this consumer started treatment with Aminoleban En (dosage: 100 G, Unk). The following drugs were being taken at the same time: NA. When using Aminoleban En, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Constipation, Hepatic Failure, Decreased Appetite, Ascites, Chest Pain, Pneumonia Aspiration, Liver Disorder, Aspartate Aminotransferase IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspnoea, may become evident only after a product is in use by the general population.
Aminoleban Side Effect Report#7521337-3
Hypertension, Delirium, Decreased Appetite, Hepatic Encephalopathy, Renal Impairment
This Hypertension side effect was reported by a physician from Japan. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Aminoleban En (drug dosage: Daily Dose 150 G), which was initiated on
Apr 07, 2010. Concurrently used drugs:
  • Omeprazole (Daily Dose 20 Mg)
  • Loxonin (Daily Dose 60 Mg)
  • Argamate (Daily Dose 75 G)
  • Lamivudine (Daily Dose 13.5 G)
  • Amlodipine (2.5 Mg (daily Dose), , Oral)
  • Amlodipine (5.0 Mg (daily Dose), , Oral)
  • Urso 250 (Daily Dose 600 Mg)
  • Nexavar (200 Mg, Bid)
.After starting to take Aminoleban En the consumer reported adverse symptoms, such as: Hypertension, Delirium, Decreased Appetite, Hepatic Encephalopathy, Renal ImpairmentThese side effects may potentially be related to Aminoleban En. The patient was hospitalized.
Aminoleban Side Effect Report#7491935-4
Metabolic Acidosis, Gastrointestinal Haemorrhage, Hepatic Encephalopathy, Hyperammonaemia, Gastrointestinal Necrosis, Somnolence, Hypoglycaemia
This is a report of a 77-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: hepatic cirrhosis,varices oesophageal, who was treated with Aminoleban En (dosage: 50 G (daily Dose), , Oral, start time:
Aug 31, 2010), combined with:
  • Famotidine (40 Mg (daily Dose), , Oral)
  • Famotidine
  • Nexavar
  • Urso 250 (600 Mg (daily Dose), , Oral)
  • Uft (300 Mg (daily Dose), , Oral)
  • Uftoral (Unk)
  • Nexavar
  • Warfarin Sodium (0.5 Mg (daily Dose), , Oral)
and developed a serious reaction and side effect(s): Metabolic Acidosis, Gastrointestinal Haemorrhage, Hepatic Encephalopathy, Hyperammonaemia, Gastrointestinal Necrosis, Somnolence, Hypoglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Aminoleban En treatment in male patients, resulting in Metabolic Acidosis side effect. The patient was hospitalized.
Aminoleban Side Effect Report#7445268-2
Hepatic Neoplasm Malignant, Blood Amylase Increased, Muscular Weakness, Blood Creatine Phosphokinase Increased
This report suggests a potential Aminoleban En Hepatic Neoplasm Malignant side effect(s) that can have serious consequences. A 82-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Aminoleban En (dosage: Daily Dose 100 G) starting
Sep 03, 2010. After starting Aminoleban En the patient began experiencing various side effects, including: Hepatic Neoplasm Malignant, Blood Amylase Increased, Muscular Weakness, Blood Creatine Phosphokinase IncreasedAdditional drugs used concurrently:
  • Nexavar (200 Mg (daily Dose), , Oral)
  • Nexavar (Daily Dose 400 Mg)
  • Digoxin (Daily Dose .125 Mg)
  • Nexavar
  • Biofermin (Daily Dose 3 G)
  • Etodolac (Daily Dose 400 Mg)
  • Metformin Hcl (Daily Dose 750 Mg)
  • Sunrythm (Daily Dose 100 Mg)
Although Aminoleban En demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Neoplasm Malignant, may still occur.
Aminoleban Side Effect Report#7250230-9
Hepatic Encephalopathy
This Hepatic Encephalopathy problem was reported by a consumer or non-health professional from United States. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hyperammonaemia,prophylaxis,hepatic neoplasm malignant. On
Feb 15, 2008 this consumer started treatment with Aminoleban (dosage: NA). The following drugs were being taken at the same time:
  • Urea
  • Sorafenib (raf Kinase Inhibitor) (400 Mg, Bid)
  • Ursodeoxycholic Acid
When using Aminoleban, the patient experienced the following unwanted symptoms/side effects: Hepatic EncephalopathyThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Encephalopathy, may become evident only after a product is in use by the general population.



The appearance of Aminoleban on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Aminoleban Side Effects for Women?

Women Side Effects Reports
Hepatic Failure 3
Ascites 2
Aspartate Aminotransferase Increased 2
Decreased Appetite 2
Dyspnoea 2
Haemorrhagic Ascites 2
Liver Disorder 2
Pneumonia Aspiration 2
Blood Amylase Increased 1
Blood Creatine Phosphokinase Increased 1

What are common Aminoleban Side Effects for Men?

Men Side Effects Reports
Hepatic Encephalopathy 3
Acute Hepatic Failure 1
Decreased Appetite 1
Delirium 1
Disseminated Intravascular Coagulation 1
Gastrointestinal Haemorrhage 1
Gastrointestinal Necrosis 1
Hepatitis 1
Hyperammonaemia 1
Hypertension 1

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Aminoleban reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    More About Aminoleban

    Side Effects reported to FDA: 11

    Aminoleban safety alerts: No

    Reported deaths: 7

    Reported hospitalizations: 6

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