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Uniphyl (Theophylline) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Uniphyl (Theophylline) 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 (4)
Death (2)
Disability (1)

Reports by Reaction Type

Rectal Haemorrhage (2)Melaena (2)Anaemia (2)Neoplasm Malignant (2)Sepsis (2)Jaundice (1)Lymphadenopathy (1)Rhabdomyolysis (1)Metastases To Liver (1)Neoplasm Progression (1)Metastases To Lung (1)Condition Aggravated (1)

Possible Uniphyl side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-14

Patient: 71 year old female

Reactions: Neoplasm Malignant, Sepsis, Rectal Haemorrhage, Anaemia, Neoplasm Progression, Condition Aggravated, Melaena

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 4 gm (1 gm, 4 in 1 d)

Acetylsalicylic Acid SRT
    Dosage: 4 gm (1 gm, 4 in 1 d)

Capecitabine
    Dosage: oral
    Administration route: Oral
    Indication: Gastric Cancer

Etamsylate (Etamsilate)
    Dosage: 2000 mg (500 mg, 4 in 1 d)
    Indication: Gastrointestinal Haemorrhage

Lansoprazole
    Dosage: 60 mg (30 mg, 2 in 1 d) per oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Dosage: 500 mg (500 mg, 1 in 1 d) per oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Tranexamic Acid
    Dosage: 3 gm (1 gm, e in 1 d) per oral
    Administration route: Oral
    Indication: Gastrointestinal Haemorrhage

Uniphyl
    Dosage: 400 mg (200 mg, 2 in 1 d)



Possible Uniphyl side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) on 2012-06-06

Patient: 71 year old female

Reactions: Lymphadenopathy, Neoplasm Malignant, Metastases To Liver, Sepsis, Anaemia, Rectal Haemorrhage, Melaena, Metastases To Lung

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 4 gm (1 gm, 4 in 1 d)
    Indication: Product Used FOR Unknown Indication

Aspirin
    Dosage: 4 gm (1 gm, 4 in 1 d)
    Indication: Product Used FOR Unknown Indication

Capecitabine
    Dosage: oral
    Administration route: Oral
    Indication: Gastric Cancer

Ethamsylate (Etamsilate)
    Dosage: 2000 mg (500 mg, 4 in 1 d)
    Indication: Gastrointestinal Haemorrhage

Lansoprazole
    Dosage: 60 mg (30 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metfformin Hydrochloride
    Dosage: 500 mg (500 mg, 1 in 1 d)
    Indication: Product Used FOR Unknown Indication

Tranexamic Acid
    Dosage: 3 gm (1 gm, 3 in 1 d),oral
    Administration route: Oral
    Indication: Haemorrhage

Uniphyl
    Dosage: 400 mg (200 mg, 1 in 1 d)
    Indication: Product Used FOR Unknown Indication



Possible Uniphyl side effects in 76 year old female

Reported by a pharmacist from Japan on 2012-03-06

Patient: 76 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Jaundice

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Imidafenacin
    Dosage: 0.1 mg, 1x/day
    Administration route: Oral
    Indication: Pollakiuria
    Start date: 2011-11-04
    End date: 2012-02-02

Lyrica
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Start date: 2011-01-05
    End date: 2011-04-21

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2010-12-29
    End date: 2011-01-04

Lyrica
    Dosage: 225 mg, 1x/day
    Administration route: Oral
    Start date: 2011-04-22
    End date: 2012-02-09

Rabeprazole Sodium
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Gastric Ulcer

Uniphyl
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Asthma

Urso 250
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Hepatitis C
    End date: 2012-02-16

Other drugs received by patient: Myonal; Alogliptin Benzoate; Diazepam; Prednisolone; Folic Acid; Aspara K



Possible Uniphyl side effects in 37 year old female

Reported by a consumer/non-health professional from Japan on 2011-12-09

Patient: 37 year old female

Reactions: Rhabdomyolysis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Clarithromycin
    Dosage: unk
    Administration route: Oral
    Indication: Pneumonia Mycoplasmal
    End date: 2011-11-14

Epinastine Hydrochloride
    Dosage: unk
    Administration route: Oral
    Indication: Pneumonia Mycoplasmal
    End date: 2011-11-14

Onon
    Dosage: unk
    Administration route: Oral
    Indication: Pneumonia Mycoplasmal
    End date: 2011-11-14

Uniphyl
    Dosage: unk
    Administration route: Oral
    Indication: Pneumonia Mycoplasmal
    End date: 2011-11-14

Other drugs received by patient: Acetaminophen; Empynase; Singulair; Symbicort; Huscode

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