Index of reports
> Cases with Off Label Use (20)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Scopolamine where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Scopolamine side effects in male
Reported by a pharmacist from Ireland on 2012-07-24
Patient: male
Reactions: Off Label Use, Therapeutic Response Unexpected, Application Site Hypersensitivity
Drug(s) suspected as cause:
Scopolamine
Other drugs received by patient: Nexium; Amlodipine Besylate; Mirtazapine; Lioresal; Losartan Potassium; Zolpidem Tatrate; Cetirizine HCL; Proscar; Galfer; Senokot / UNK /; Citalopram Hydrobromide; Solpadeine / IRE /; Lactulose
Possible Scopolamine side effects in male
Reported by a pharmacist from Denmark on 2012-07-24
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Off Label Use, Swollen Tongue
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Scopolamine
Other drugs received by patient: Acetaminophen
Possible Scopolamine side effects in female
Reported by a physician from United Kingdom on 2012-07-10
Patient: female, weighing 89.0 kg (195.8 pounds)
Reactions: Off Label Use, Weight Increased, Sedation, Obesity, Tachycardia, Constipation, Faecaloma
Drug(s) suspected as cause:
Clozaril
Dosage: 50 mg, bid
Clozaril
Dosage: 50 mg, unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2010-07-01
Clozaril
Dosage: 75mg in morning and 100mg in evening
Scopolamine
Dosage: 1 df, q72h
Indication: Salivary Hypersecretion
Start date: 2010-09-01
Other drugs received by patient: Procyclidine Hydrochloride 2MG TAB; Valproic Acid; Diazepam
Possible Scopolamine side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-07-10
Patient: female, weighing 89.0 kg (195.8 pounds)
Reactions: Weight Increased, Off Label Use, Sedation, Obesity, Tachycardia, Constipation, Faecaloma
Drug(s) suspected as cause:
Clozaril
Dosage: 75mg in morning and 100mg in evening
Clozaril
Dosage: 50 mg, unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2010-07-01
Clozaril
Dosage: 50 mg, bid
Scopolamine
Dosage: 1 df, q72h
Indication: Salivary Hypersecretion
Start date: 2010-09-01
Other drugs received by patient: Procyclidine Hydrochloride 2MG TAB; Diazepam; Valproic Acid
Possible Scopolamine side effects in 85 year old male
Reported by a consumer/non-health professional from United Kingdom on 2012-07-03
Patient: 85 year old male
Reactions: Incoherent, Off Label Use, Urinary Tract Infection, Coordination Abnormal, Tremor
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Scopolamine
Possible Scopolamine side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-02
Patient: female
Reactions: Confusional State, Off Label Use, Speech Disorder, Mydriasis, Erythema, Altered State of Consciousness
Drug(s) suspected as cause:
Scopolamine
Possible Scopolamine side effects in male
Reported by a pharmacist from Denmark on 2012-06-22
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Off Label Use, Swollen Tongue
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Scopolamine
Possible Scopolamine side effects in female
Reported by a physician from United Kingdom on 2012-06-19
Patient: female, weighing 89.0 kg (195.8 pounds)
Reactions: Off Label Use, Weight Increased, Tachycardia, Sedation, Obesity, Constipation, Faecaloma
Drug(s) suspected as cause:
Clozaril
Dosage: 50 mg, bid
Clozaril
Dosage: 50 mg, unk
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2010-08-25
Clozaril
Dosage: 75mg in morning and 100mg in evening
Scopolamine
Dosage: 1 df, q72h
Indication: Salivary Hypersecretion
Start date: 2010-09-01
Other drugs received by patient: Diazepam; Procyclidine Hydrochloride 2MG TAB; Valproic Acid
Possible Scopolamine side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-19
Patient: female, weighing 89.0 kg (195.8 pounds)
Reactions: Weight Increased, Off Label Use, Tachycardia, Obesity, Sedation, Constipation, Faecaloma
Drug(s) suspected as cause:
Clozaril
Dosage: 50 mg, bid
Clozaril
Dosage: 75mg in morning and 100mg in evening
Clozaril
Dosage: 50 mg, unk
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2010-08-25
Scopolamine
Dosage: 1 df, q72h
Indication: Salivary Hypersecretion
Start date: 2010-09-01
Other drugs received by patient: Valproic Acid; Diazepam; Procyclidine Hydrochloride 2MG TAB
Possible Scopolamine side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-07
Patient: 69 year old male
Reactions: Off Label Use, Unresponsive To Stimuli, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Scopolamine
Other drugs received by patient: Haloperidol; Aspirin; Lidocaine; Bisoprolol Fumarate; Furosemide; Oxycodone HCL; Gabapentin
Possible Scopolamine side effects in female
Reported by a consumer/non-health professional from NEW Zealand on 2012-02-06
Patient: female
Reactions: Dysgeusia, Off Label Use, Dysphagia, Pharyngeal Oedema, Oedema Mouth, Vocal Cord Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Scopolamine
Possible Scopolamine side effects in 11 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-25
Patient: 11 year old female, weighing 48.0 kg (105.6 pounds)
Reactions: Off Label Use, Diplopia, Nightmare, Hallucination, Auditory, Incorrect Dose Administered, Hallucination, Nervousness
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Scopolamine
Other drugs received by patient: Acetaminophen
Possible Scopolamine side effects in female
Reported by a consumer/non-health professional from France on 2012-01-20
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Off Label Use, Wrong Technique in Drug Usage Process, Abasia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Scopolamine
Possible Scopolamine side effects in female
Reported by a pharmacist from France on 2012-01-16
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Off Label Use, Wrong Technique in Drug Usage Process, Abasia, Incorrect Dose Administered
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Scopolamine
Possible Scopolamine side effects in 15 year old
Reported by a pharmacist from Norway on 2011-12-23
Patient: 15 year old
Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Diplopia, Headache
Drug(s) suspected as cause:
Scopolamine
Dosage: 1 df, unk
Start date: 2011-12-11
Scopolamine
Dosage: 1 df, q72h
Indication: Nausea
Start date: 2011-12-07
End date: 2011-12-11
Other drugs received by patient: Ondansetron; Medrol; Acetaminophen; Ibuprofen; Esomeprazole Magnesium
Possible Scopolamine side effects in 15 year old
Reported by a pharmacist from Norway on 2011-12-20
Patient: 15 year old
Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Diplopia, Headache
Drug(s) suspected as cause:
Scopolamine
Dosage: 1 df, unk
Start date: 2011-12-11
Scopolamine
Dosage: 1 df, q72h
Indication: Nausea
Start date: 2011-12-07
End date: 2011-12-11
Other drugs received by patient: Medrol; Acetaminophen; Ibuprofen; Esomeprazole; Ondansetron
Possible Scopolamine side effects in 76 year old female
Reported by a consumer/non-health professional from Germany on 2011-11-04
Patient: 76 year old female
Reactions: Off Label Use, Vomiting, Nausea, Urinary Retention
Drug(s) suspected as cause:
Scopolamine
Possible Scopolamine side effects in 16 year old male
Reported by a physician from United Kingdom on 2011-10-27
Patient: 16 year old male, weighing 28.0 kg (61.6 pounds)
Reactions: Incorrect Route of Drug Administration, Vomiting, Wrong Technique in Drug Usage Process, Pruritus, Dyskinesia, Eructation, Food Aversion, Off Label Use, Rash Erythematous, Application Site Irritation, Hypersomnia
Drug(s) suspected as cause:
Metoclopramide
Dosage: 5 to 10mg, prn
Indication: Vomiting
Start date: 2011-09-05
Scopolamine
Dosage: 1 df, q72h
Indication: Salivary Hypersecretion
Start date: 2011-05-16
End date: 2011-09-16
Scopolamine
Dosage: unk, unk
Start date: 2002-01-01
End date: 2002-01-01
Scopolamine
Administration route: Oral
Start date: 2011-09-16
End date: 2011-09-16
Possible Scopolamine side effects in male
Reported by a consumer/non-health professional from Germany on 2011-10-25
Patient: male
Reactions: Wrong Technique in Drug Usage Process, Paresis, Extrasystoles, Quality of Life Decreased, Pallor, Somnolence, Death, Poor Quality Sleep, Off Label Use, Fatigue, Oedema Peripheral, Respiratory Muscle Weakness, Sudden Onset of Sleep, Oxygen Saturation Decreased, Motor Dysfunction, General Physical Health Deterioration, Cognitive Disorder, Anxiety, Hypopnoea, Depressed Level of Consciousness, Mobility Decreased
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Scopolamine
Dosage: 0.25 df, q72h
Indication: Salivary Hypersecretion
Start date: 2011-03-15
Scopolamine
Dosage: 0.5 df, q72h
Start date: 2011-03-14
End date: 2011-03-14
Other drugs received by patient: Metoprolol Succinate; Levothyroxine Sodium; NON-Drug: Bandages
Possible Scopolamine side effects in male
Reported by a pharmacist from United Kingdom on 2011-10-19
Patient: male, weighing 28.0 kg (61.6 pounds)
Reactions: Incorrect Route of Drug Administration, Pruritus, Wrong Technique in Drug Usage Process, Vomiting, Dyskinesia, Eructation, Food Aversion, Off Label Use, Rash Erythematous, Hypersomnia, Application Site Irritation
Drug(s) suspected as cause:
Metoclopramide
Dosage: 5 to 10mg, prn
Indication: Vomiting
Start date: 2011-09-05
Scopolamine
Dosage: unk, unk
Start date: 2002-01-01
End date: 2002-01-01
Scopolamine
Dosage: 1 df, q72h
Indication: Salivary Hypersecretion
Start date: 2011-05-16
End date: 2011-09-16
Scopolamine
Administration route: Oral
Start date: 2011-09-16
End date: 2011-09-16
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