Index of reports
> Cases with Off Label Use (22)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Miralax (Polyethylene Glycol 3350) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient:
Reactions: Off Label Use, Anal Pruritus, Drug Administered To Patient of Inappropriate AGE
Drug(s) suspected as cause:
Miralax
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-25
Patient:
Reactions: Vomiting, Nausea, Headache, Hyperhidrosis, Abdominal Pain Upper, Paraesthesia, Off Label Use, Overdose
Drug(s) suspected as cause:
Miralax
Dosage: unk, qh
Administration route: Oral
Indication: Colonoscopy
Miralax
Indication: Medical Observation
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Off Label Use, Pain, Underdose, Eructation
Drug(s) suspected as cause:
Miralax
Dosage: unk, unknown
Administration route: Oral
Indication: Medical Observation
Miralax
Indication: Bowel Preparation
Other drugs received by patient: Aspirin
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Off Label Use, Incorrect Drug Administration Duration, Faeces Discoloured
Drug(s) suspected as cause:
Miralax
Dosage: unk, unknown
Administration route: Oral
Indication: Colonoscopy
Start date: 2012-07-01
Miralax
Indication: Medical Observation
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient:
Reactions: Off Label Use, Incorrect Drug Administration Duration, Drug Administered To Patient of Inappropriate AGE
Drug(s) suspected as cause:
Miralax
Dosage: unk, qd
Administration route: Oral
Indication: Constipation Prophylaxis
Miralax
Indication: Medical Observation
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Off Label Use, Overdose
Drug(s) suspected as cause:
Miralax
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Off Label Use, Vomiting, Overdose
Drug(s) suspected as cause:
Miralax
Dosage: 255 g, once
Administration route: Oral
Indication: Bowel Preparation
Start date: 2012-07-25
Miralax
Indication: Colonoscopy
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient:
Reactions: Off Label Use, Overdose, Diarrhoea, Abnormal Faeces
Drug(s) suspected as cause:
Miralax
Indication: Medical Observation
Miralax
Dosage: 119 g, once
Administration route: Oral
Indication: Colonoscopy
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient:
Reactions: Off Label Use, Overdose, Drug Ineffective, Drug Administered To Patient of Inappropriate AGE
Drug(s) suspected as cause:
Miralax
Dosage: 17 g, qid
Administration route: Oral
Indication: Constipation
Start date: 2012-07-03
Miralax
Indication: Medical Observation
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient:
Reactions: Off Label Use, Incorrect Drug Administration Duration, Glossodynia, Foreign Body
Drug(s) suspected as cause:
Miralax
Indication: Medical Observation
Miralax
Indication: Polyp
Miralax
Dosage: 17 g, qd
Administration route: Oral
Indication: Functional Gastrointestinal Disorder
Start date: 2009-01-01
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient:
Reactions: Off Label Use, Overdose, Drug Administered To Patient of Inappropriate AGE
Drug(s) suspected as cause:
Miralax
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient:
Reactions: Off Label Use, Overdose
Drug(s) suspected as cause:
Miralax
Dosage: 17 g, tid
Administration route: Oral
Indication: Medical Observation
Start date: 2012-05-30
Miralax
Indication: Colonoscopy
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient:
Reactions: Off Label Use, Frequent Bowel Movements, Drug Administered To Patient of Inappropriate AGE
Drug(s) suspected as cause:
Miralax
Indication: Medical Observation
Miralax
Dosage: 17 g, unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient:
Reactions: Off Label Use, Overdose, Wrong Technique in Drug Usage Process, Nausea, Drug Effect Increased, Blood Electrolytes Decreased
Drug(s) suspected as cause:
Miralax
Indication: Medical Observation
Miralax
Dosage: unk unk, unknown
Administration route: Oral
Indication: Colonoscopy
Start date: 2012-04-24
End date: 2012-04-25
Other drugs received by patient: ONE-A-DAY Essential Vitamins; Iron (Unspecified); Kelp; Calcium (Unspecified) (+) Vitamin D (Unspecified); Xanthophyll
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient:
Reactions: Off Label Use, Drug Ineffective FOR Unapproved Indication
Drug(s) suspected as cause:
Miralax
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient:
Reactions: Off Label Use, Swelling Face
Drug(s) suspected as cause:
Miralax
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient:
Reactions: Dysgeusia, Off Label Use, Drug Administered To Patient of Inappropriate AGE
Drug(s) suspected as cause:
Miralax
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient:
Reactions: Off Label Use, Incorrect Storage of Drug
Drug(s) suspected as cause:
Miralax
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient:
Reactions: Off Label Use, Nasopharyngitis, Drug Administered To Patient of Inappropriate AGE, Blood Glucose Increased
Drug(s) suspected as cause:
Miralax
Dosage: unk, qam
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-21
Miralax
Indication: Medical Observation
Possible Miralax side effects in
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient:
Reactions: Off Label Use, Drug Administered To Patient of Inappropriate AGE
Drug(s) suspected as cause:
Miralax
Indication: Medical Observation
Miralax
Dosage: unk, unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Miralax side effects in male
Reported by a physician from United States on 2011-12-23
Patient: male
Reactions: Somnolence, Off Label Use, Haematocrit Decreased, Fatigue, Aspiration, Dizziness, Hypoxia, Vomiting, Alanine Aminotransferase Increased, Sensation of Heaviness, Muscular Weakness, Toxicity To Various Agents, Haemoglobin Decreased, Diarrhoea, Blood Potassium Decreased, Hypophagia, Dehydration, Aspartate Aminotransferase Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Alimta
Dosage: unk
Indication: Oropharyngeal Cancer Recurrent
Erlotinib Hydrochloride
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Oropharyngeal Cancer Recurrent
Start date: 2011-10-12
Erlotinib Hydrochloride
Dosage: 150 mg, uid/qd
Administration route: Oral
End date: 2011-10-28
External Beam Radiation Therapy
Dosage: weekly, ex. beam
Indication: Oropharyngeal Cancer Recurrent
Start date: 2011-10-13
Miralax
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Glimepiride; Lidoderm; Oxycodone HCL; Ativan; Folic Acid; Levothyroxine Sodium; Colace; Ativan; Neurontin; Ambien; Duragesic-100; Prochlorperazine Maleate; Zofran; Proair HFA
Possible Miralax side effects in male
Reported by a physician from United States on 2011-12-12
Patient: male
Reactions: Vomiting, Alanine Aminotransferase Increased, Febrile Neutropenia, Muscular Weakness, Off Label Use, Fatigue, Diarrhoea, Aspiration, Dehydration, Hypophagia, Aspartate Aminotransferase Increased, Hypoxia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Alimta
Dosage: unk
Indication: Oropharyngeal Cancer Recurrent
Erlotinib Hydrochloride
Dosage: 150 mg, uid/qd
Administration route: Oral
End date: 2011-10-28
Erlotinib Hydrochloride
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Oropharyngeal Cancer Recurrent
Start date: 2011-10-12
External Beam Radiation Therapy
Dosage: weekly, ex. beam
Indication: Oropharyngeal Cancer Recurrent
Start date: 2011-10-13
Miralax
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Colace; Folic Acid; Oxycodone HCL; Ativan; Levothyroxine Sodium; Glimepiride; Zofran; Proair HFA; Neurontin; Prochlorperazine Maleate; Ambien; Lidoderm; Ativan; Duragesic-100
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