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Buphenyl (Phenylbutyrate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Buphenyl (Phenylbutyrate) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (5)
Death (1)
Life Threatening Events (1)

Reports by Reaction Type

Dizziness (4)Vomiting (4)Ataxia (4)Aggression (4)Irritability (4)Hyperammonaemia (4)Salivary Hypersecretion (3)Stress (3)Alopecia (3)Gait Disturbance (3)Personality Change (2)Impulsive Behaviour (2)

Possible Buphenyl side effects in 3 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-14

Patient: 3 year old male, weighing 18.1 kg (39.8 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Tachycardia, Hepatic Failure, Haemoconcentration, Constipation, Liver Disorder, Blood Creatinine Decreased, Multi-Organ Failure, Dialysis, Mood Altered, Amino Acid Metabolism Disorder, Tachypnoea, Use of Accessory Respiratory Muscles, Oxygen Saturation Decreased, Metabolic Acidosis, Hypotension, Urine Output Decreased, Condition Aggravated, DRY Skin, Blood Lactic Acid Increased, Arrhythmia, Hypoproteinaemia, Cardiac Failure, Alopecia, Respiratory Arrest

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Buphenyl
    Dosage: 9000 mg;qd;po ; 300 mg;qd;po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-10-13
    End date: 2011-10-27

Buphenyl
    Dosage: 9000 mg;qd;po ; 300 mg;qd;po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-09-22
    End date: 2011-10-12

Other drugs received by patient: Citrulline Powder; Racol-NF Liquid FOR Enteral USE; Amiyu Granule; Benzalin Fine Granules 1%; Solita-T Granules NO 3; Elental; Monilac Syrup; L-Cartin Tablets; Sodium Benzoate Powder; Glycerin Enema 50%



Possible Buphenyl side effects in 17 year old female

Reported by a consumer/non-health professional from Japan on 2012-03-06

Patient: 17 year old female, weighing 40.8 kg (89.8 pounds)

Reactions: Personality Change, Vomiting, Ataxia, Impulsive Behaviour, Stress, Aggression, Irritability, Alopecia, Hyperammonaemia, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buphenyl
    Dosage: 13500 mg;qd;po, 10000 mg;tid;po, 6700 mg;bid;po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-09-22
    End date: 2011-10-03

Buphenyl
    Dosage: 13500 mg;qd;po, 10000 mg;tid;po, 6700 mg;bid;po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-10-07
    End date: 2011-10-10

Buphenyl
    Dosage: 13500 mg;qd;po, 10000 mg;tid;po, 6700 mg;bid;po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-10-04
    End date: 2011-10-06

Other drugs received by patient: Asverin Powder (Tipepidine Hibenzate); Cravit Ophthalmic Solution 0.5% (Levofloxacin Hydrate); Solunim Cream (Flucinonide); Allelock Tablets (Olopatadine Hydrochloride); Pulsmarin A DRY Syrup FOR Pediatric (Ambroxol Hydrochloride); Amiyu Granule (Essential Amino Acids FOR Renal Insufficiency); Mucodyne DRY Syrup 50% (L-Carbocisteine); Hokunalin Tape 2 MG (Tulobuterol); Sulfur and Camphor Lotion



Possible Buphenyl side effects in 17 year old female

Reported by a consumer/non-health professional from Japan on 2011-12-28

Patient: 17 year old female, weighing 40.8 kg (89.8 pounds)

Reactions: Personality Change, Vomiting, Ataxia, Impulsive Behaviour, Stress, Aggression, Irritability, Hyperammonaemia, Alopecia, Dizziness, Salivary Hypersecretion, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buphenyl
    Dosage: 13500 mg;qd;po 10000 mg;qd;po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-09-22
    End date: 2011-10-03

Buphenyl
    Dosage: 13500 mg;qd;po 10000 mg;qd;po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-10-04
    End date: 2011-10-10

Other drugs received by patient: Mucodyne DRY Syrup 50% (L-Carbocisteine); Amiyu Granule (Essential Amino Acids FOR Renal Insufficiency); Allelock Tablets (Olopatadine Hydrochloride); Hokunalin Tape 2 MG (Tulobuterol); Solunim Cream (Fluocinonide); Pulsmarin A DRY Syrup FOR Pediatric (Ambroxol Hydrochloride); Sulfur and Camphor Lotion (Sulfur and Camphor); Asverin Powder (Tipepidine Hibenzate); Cravit Ophthalmic Solution 0.5% (Levofloxacin Hydrate)



Possible Buphenyl side effects in 17 year old female

Reported by a individual with unspecified qualification from Japan on 2011-11-17

Patient: 17 year old female, weighing 40.8 kg (89.8 pounds)

Reactions: Irritability, Vomiting, Hyperammonaemia, Dizziness, Ataxia, Gait Disturbance, Salivary Hypersecretion, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buphenyl
    Dosage: 13500;10000 mg, qd, po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-10-04
    End date: 2011-10-10

Buphenyl
    Dosage: 13500;10000 mg, qd, po
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-09-22
    End date: 2011-10-03

Other drugs received by patient: Allelock Tablets (Olopatadine Hydrochloride); Sulfur and Camphor Lotion (Sulfur and Camphor); Asverin Powder (Tipepidine Hibenzate); Amiyu Granule (Essential Amino Acids FOR Renal Insufficiency); Pylsmarin A DRY Syrup Fopr Pediatric (Ambroxol Hydrochloride); Solunim Cream (Flucononide); Mucodyne DRY Syrup (L-Carbocisteine); Hokunalin Tape 2 MG (Tulobuterol); Cravit Ophthalmic Solution (Levofloxacin Hydrate)



Possible Buphenyl side effects in 17 year old female

Reported by a individual with unspecified qualification from Japan on 2011-10-25

Patient: 17 year old female, weighing 40.8 kg (89.8 pounds)

Reactions: General Physical Condition Abnormal, Vomiting, Ataxia, Stress, Aggression, Irritability, Hyperammonaemia, Dizziness, Gait Disturbance, Salivary Hypersecretion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Buphenyl
    Dosage: 1350 mg;qd;po ; 1000 mg;qd
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-10-04
    End date: 2011-10-10

Buphenyl
    Dosage: 1350 mg;qd;po ; 1000 mg;qd
    Administration route: Oral
    Indication: Amino Acid Metabolism Disorder
    Start date: 2011-09-22
    End date: 2011-10-03

Other drugs received by patient: Hokunalin Tape 2 MG (Tulobuterol); Cravit Ophthalmic Solution 0.5% (Levofloxacin Hydrate); Asverin Powder (Tipepidine Hibenzate); Amiyu Granule (Essential Amino Acids FOR Renal Insufficiency); Allelock Tablets (Olopatadine Hydrochloride); Pulsmarin A DRY Syrup FOR Pediatric (Ambroxol Hydrochloride); Mucodyne DRY Syrup 50% (L-Carbocisteine); Sulfur and Camphor Lotion (Sulfur and Camphor; Solunim Cream (Fluocinonide)

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