Index of reports
> Cases with Off Label Use (151)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Cymbalta (Duloxetine) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 151 Next >>
Possible Cymbalta side effects in 42 year old female
Reported by a physician from United States on 2012-08-27
Patient: 42 year old female
Reactions: Disorientation, Somnolence, Loss of Consciousness, Off Label Use, Vital Functions Abnormal, Speech Disorder, Fatigue, Dizziness, Blood Pressure Increased, Nausea, Drug Withdrawal Syndrome, Heart Rate Decreased, Presyncope, Dissociation, Feeling Abnormal, Asthenia
Drug(s) suspected as cause:
Cymbalta
Dosage: 30 mg, bid
Administration route: Oral
End date: 2012-05-09
Cymbalta
Dosage: 30 mg, qd
Administration route: Oral
Start date: 2012-05-10
End date: 2012-05-10
Cymbalta
Dosage: 30 mg, qd
Administration route: Oral
Indication: Neuralgia
Start date: 2012-05-01
Other drugs received by patient: Lisinopril; Lortab
Possible Cymbalta side effects in 46 year old female
Reported by a physician from Australia on 2012-08-24
Patient: 46 year old female
Reactions: Off Label Use, Electrocardiogram QT Prolonged, Ventricular Fibrillation
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Cymbalta
Administration route: Oral
Seroquel
Administration route: Oral
Other drugs received by patient: Opiates; Reboxetine
Possible Cymbalta side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Muscle Contractions Involuntary, Urinary Incontinence, Loss of Consciousness, Off Label Use, Fatigue, Liver Function Test Abnormal, Urinary Retention, Nervousness, Dysphagia, Dyspnoea, Vomiting, Drug Withdrawal Syndrome, Epilepsy, Convulsion, Dehydration, Feeling Abnormal
Drug(s) suspected as cause:
Cymbalta
Possible Cymbalta side effects in 56 year old female
Reported by a physician from United States on 2012-08-23
Patient: 56 year old female
Reactions: Off Label Use, Obesity Surgery, Wrong Technique in Drug Usage Process, Psychiatric Decompensation
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Antipsychotics
Possible Cymbalta side effects in 41 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 41 year old female
Reactions: Confusional State, Paraesthesia Oral, Drug Detoxification, Intentional Drug Misuse, Bruxism, Drug Withdrawal Syndrome, Paraesthesia, Off Label Use, Toothache, Tardive Dyskinesia, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 90 mg, unknown
Indication: Bipolar I Disorder
Start date: 2010-02-01
Cymbalta
Dosage: 30 mg, qd
Other drugs received by patient: Zanaflex; Stool Softener; Citracal; Propranolol; Neurontin; Zyrtec; Lamictal; Glucosamine; Niacin; Synthroid; Mobic; Allegra; Calcium
Possible Cymbalta side effects in 17 year old male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 17 year old male
Reactions: Off Label Use, Hospitalisation, Wrong Technique in Drug Usage Process
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Possible Cymbalta side effects in female
Reported by a physician from Italy on 2012-08-15
Patient: female
Reactions: Off Label Use, Large Intestinal Obstruction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Pantoprazole Sodium; Idroplurivit; Calcium Carbonate; Benerva; Furosemide; Aspirin; Eprex; Sodium Bicarbonate; Aldomet; Folic Acid; Lexotan
Possible Cymbalta side effects in 17 year old female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 17 year old female
Reactions: Off Label Use, Completed Suicide, Coma
Adverse event resulted in: death
Drug(s) suspected as cause:
Cymbalta
Possible Cymbalta side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: male
Reactions: Off Label Use, Confusional State, Incoherent, Bradycardia, Fall, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Simvastan; Warfarin Sodium
Possible Cymbalta side effects in 57 year old male
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 57 year old male
Reactions: Tinnitus, Dyspnoea, Polycythaemia, Abnormal Behaviour, Intentional Drug Misuse, Chronic Obstructive Pulmonary Disease, Erythema, Hyperhidrosis, Off Label Use, Ocular Hyperaemia, Dizziness, Anger, Withdrawal Syndrome, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 30 mg, qd
Indication: Anger
Start date: 2004-01-01
Cymbalta
Dosage: 60 mg, qd
Cymbalta
Dosage: 30 mg, qd
Start date: 2012-01-01
Cymbalta
Dosage: 30 mg, qod
Start date: 2012-01-01
Prozac
Dosage: unk
Indication: Anger
Start date: 1995-02-01
Other drugs received by patient: Vicodin ES; Prevacid; Carvedilol; Flaxseed OIL; Garlic; Xanax; Lovaza; Spironolactone; Aspirin; Soma; Furosemide; Flovent; Ipratropium Bromide; Plavix; Crestor; Multi-Vitamin; Prozac; Albuterol Sulfate; Lisinopril; Testosterone
Possible Cymbalta side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 49 year old female
Reactions: Off Label Use, Gastric Bypass, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 1 df, unk
Indication: Ankylosing Spondylitis
Cymbalta
Dosage: 1 df, unk
End date: 2012-03-01
Possible Cymbalta side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: female
Reactions: Off Label Use, Confusional State, Pain, Adverse Event, Rotator Cuff Syndrome, Fall
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Lipitor; Bystolic; Dyazide; Xanax; Micro-K; Hydrocodone Bitartrate
Possible Cymbalta side effects in female
Reported by a physician from Italy on 2012-08-10
Patient: female
Reactions: Off Label Use, Large Intestinal Obstruction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Lexotan; Calcium Carbonate; Aldomet; Furosemide; Folic Acid; Idroplurivit; Sodium Bicarbonate; Aspirin; Pantoprazole Sodium; Eprex; Benerva
Possible Cymbalta side effects in 42 year old female
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 42 year old female
Reactions: Blood Pressure Increased, Nausea, Drug Withdrawal Syndrome, Somnolence, Loss of Consciousness, Off Label Use, Vital Functions Abnormal, Speech Disorder, Heart Rate Decreased, Fatigue, Presyncope, Dissociation, Dizziness, Asthenia, Feeling Abnormal
Drug(s) suspected as cause:
Cymbalta
Dosage: 30 mg, bid
Administration route: Oral
End date: 2012-05-09
Cymbalta
Dosage: 30 mg, qd
Administration route: Oral
Start date: 2012-05-10
End date: 2012-05-10
Cymbalta
Dosage: 30 mg, qd
Administration route: Oral
Indication: Neuralgia
Start date: 2012-05-01
Other drugs received by patient: Lortab; Lisinopril
Possible Cymbalta side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: female
Reactions: Migraine, Confusional State, Pruritus, Vomiting, Retching, Drug Withdrawal Syndrome, Disorientation, Hyperhidrosis, Dysarthria, Off Label Use, Vision Blurred
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Lamictal; Isometheptene; Indomethacin; Naprosyn; Levothroid; Valtrex; Neurontin
Possible Cymbalta side effects in male
Reported by a physician from Japan on 2012-08-06
Patient: male
Reactions: Off Label Use, Pneumonia Aspiration, Somnolence
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Lansoprazole; Voltaren; Oxycontin; Etodolac; Oxycontin; Magmitt; Zometa; Oxycontin; Oxinorm / 00045603 /; Oxinorm / 00045603 /; Lasix; Oxycontin; Flomox; Voltaren; Lyrica
Possible Cymbalta side effects in 50 year old male
Reported by a consumer/non-health professional from Greece on 2012-08-02
Patient: 50 year old male
Reactions: Jaundice, Off Label Use, Intentional Drug Misuse
Drug(s) suspected as cause:
Cymbalta
Possible Cymbalta side effects in 78 year old male
Reported by a physician from United States on 2012-08-02
Patient: 78 year old male
Reactions: Confusional State, Agitation, Atrial Fibrillation, Drug Withdrawal Syndrome, Cognitive Disorder, Gastrointestinal Tube Insertion, Off Label Use, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Tylenol / SCH /; Hydralazine HCL; Pantoprazole; Aspirin; Labetalol HCL; Propofol; Dilaudid
Possible Cymbalta side effects in 33 year old female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: 33 year old female
Reactions: LIP Swelling, Body Temperature Fluctuation, Anaphylactic Reaction, Wheezing, Urticaria, Intentional Drug Misuse, Hyperhidrosis, Off Label Use, Thinking Abnormal, Oedema Mouth, Mood Swings, Cold Sweat, Vomiting, Nausea, Swollen Tongue, Tremor, Paraesthesia, Diarrhoea, Presyncope, Withdrawal Syndrome
Drug(s) suspected as cause:
Cymbalta
Dosage: 60 mg, qd
Indication: Depression
End date: 2012-07-15
Zyprexa
Dosage: 10 mg, each evening
Indication: Withdrawal Syndrome
Start date: 2012-06-01
Possible Cymbalta side effects in 58 year old male
Reported by a consumer/non-health professional from United States on 2012-07-31
Patient: 58 year old male
Reactions: Off Label Use, Skin Discolouration, Exfoliative Rash, Erythema, Blister, Rash Macular
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Doxycycline HCL
Possible Cymbalta side effects in 40 year old male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: 40 year old male
Reactions: Off Label Use, Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 120 mg, qd
Indication: Anxiety
Zyprexa
Dosage: 1 df, unknown
Indication: Anxiety
Zyprexa
Dosage: 10 mg, bid
Possible Cymbalta side effects in 50 year old male
Reported by a consumer/non-health professional from Greece on 2012-07-26
Patient: 50 year old male
Reactions: Jaundice, Off Label Use, Intentional Drug Misuse
Drug(s) suspected as cause:
Cymbalta
Possible Cymbalta side effects in female
Reported by a consumer/non-health professional from Sweden on 2012-07-26
Patient: female
Reactions: Off Label Use, Joint Dislocation, Convulsion
Drug(s) suspected as cause:
Cymbalta
Possible Cymbalta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: female
Reactions: Pruritus, Buccal Mucosal Roughening, Skin Irritation, Off Label Use, Gingival Recession, Dermatitis Bullous, Unevaluable Event, Sensitivity of Teeth, Feeling Abnormal, Scar
Drug(s) suspected as cause:
Cymbalta
Dosage: 30 mg, bid
Indication: Neuropathy Peripheral
Start date: 2010-01-01
Cymbalta
Dosage: 60 mg, unk
Cymbalta
Dosage: 30 mg, bid
End date: 2012-05-01
Other drugs received by patient: Allopurinol; Neurontin / USA /; Zestoretic; Lasix / USA /; Zebeta; Estrace; Synthroid
Possible Cymbalta side effects in female
Reported by a physician from Japan on 2012-07-24
Patient: female, weighing 33.0 kg (72.6 pounds)
Reactions: Off Label Use, Syncope, Loss of Consciousness
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Novolin 30R / 00806401 /; Lyrica; Miglitol; Cephadol; Acetaminophen; Zetia; Novolin 30R / 00806401 /; Selbex
Possible Cymbalta side effects in 45 year old female
Reported by a consumer/non-health professional from France on 2012-07-23
Patient: 45 year old female
Reactions: Weight Decreased, Abdominal Pain, Vomiting, Haematuria, Urinary Tract Infection, General Physical Health Deterioration, Pyrexia, Cholelithiasis, Off Label Use, Hepatomegaly, Biliary Abscess, Insomnia, Depressed Mood, Asthenia, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 30 mg, qd
Administration route: Oral
End date: 2012-06-03
Cymbalta
Dosage: 60 mg, qd
Administration route: Oral
End date: 2012-06-03
Cymbalta
Dosage: 60 mg, qd
Administration route: Oral
Indication: Depression
Start date: 2012-04-20
End date: 2012-04-30
Possible Cymbalta side effects in female
Reported by a consumer/non-health professional from Switzerland on 2012-07-23
Patient: female, weighing 98.0 kg (215.6 pounds)
Reactions: Off Label Use, Alcohol Abuse, Gamma-Glutamyltransferase Increased, Drug Abuse, Hepatic Enzyme Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Acetaminophen; Lyrica; Seroquel; Alcohol
Possible Cymbalta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: female
Reactions: Off Label Use, Yellow Skin
Drug(s) suspected as cause:
Cymbalta
Possible Cymbalta side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: 74 year old female
Reactions: Off Label Use, Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Other drugs received by patient: Synthroid; Lisinopril; Amiodarone HCL
Possible Cymbalta side effects in 55 year old female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: 55 year old female
Reactions: Off Label Use, Road Traffic Accident, Nightmare, Insomnia, Headache, Peripheral Nerve Decompression, Discomfort
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 30 mg, bid
Cymbalta
Dosage: 60 mg, qd
Cymbalta
Dosage: 60 mg, bid
Cymbalta
Dosage: 30 mg, qd
Indication: Trigeminal Neuralgia
Other drugs received by patient: Ibuprofen; Klonopin; Valium; Oxycontin
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