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Cymbalta (Duloxetine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cymbalta (Duloxetine) 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 (2596)
Death (121)
Life Threatening Events (165)
Disability (81)

Reports by Reaction Type

Nausea (263)Dizziness (233)Drug Ineffective (224)Pain (179)Drug Withdrawal Syndrome (173)Depression (169)Insomnia (166)Headache (163)Feeling Abnormal (158)Fatigue (155)Vomiting (152)Off Label Use (151)

Below are a few examples of reports where side effects / adverse reactions may be related to Cymbalta (Duloxetine). For a complete list or a specific selection of reports, please use the links above.

Possible Cymbalta side effects in 70 year old male

Reported by a physician from United States on 2012-08-27

Patient: 70 year old male

Reactions: Anaemia, Blood Count Abnormal

Drug(s) suspected as cause:
Cymbalta
    Dosage: 30 mg, qd

Cymbalta
    Dosage: 30 mg, bid
    Indication: Musculoskeletal Pain



Possible Cymbalta side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 49 year old female

Reactions: Dysphagia, Asthenia, Muscle Disorder

Drug(s) suspected as cause:
Cymbalta



Possible Cymbalta side effects in female

Reported by a physician from France on 2012-08-27

Patient: female

Reactions: Confusional State, Acute Pulmonary Oedema, Agitation, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Administration route: Oral

Atorvastatin
    Administration route: Oral

Bisoprolol Fumarate
    Dosage: 2.5 mg in the morning and 1.25 mg in the evening
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Administration route: Oral

Nitroglycerin
    End date: 2012-07-26

Plavix
    Administration route: Oral

Ramipril
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Start date: 2012-07-19
    End date: 2012-07-19



Possible Cymbalta side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Malaise, Drug Withdrawal Syndrome, Diabetic Gastroparesis

Drug(s) suspected as cause:
Cymbalta



Possible Cymbalta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Renal Failure Chronic

Drug(s) suspected as cause:
Cymbalta

Other drugs received by patient: Insulin; Crestor; Cozaar



Possible Cymbalta side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 61 year old female

Reactions: Agitation, Confusional State, Acute Pulmonary Oedema, Metastatic Pain, Hypercalcaemia, Renal Failure Acute

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

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 g, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Dosage: 75 mg, 1x/day
    Administration route: Oral

Atorvastatin
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Bisoprolol Fumarate
    Dosage: 3.75 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Dosage: 60 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    Dosage: 50 mg, 1x/day
    End date: 2012-07-26

Lercanidipine
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Dosage: 20 mg, 1x/day
    Administration route: Oral

Nitroglycerin
    Dosage: 5 mg, 1x/day
    End date: 2012-07-26

Plavix
    Dosage: 75 mg, 1x/day
    Administration route: Oral

Ramipril
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Dosage: 4 mg, single
    Indication: Hypercalcaemia
    Start date: 2012-07-19
    End date: 2012-07-19



Possible Cymbalta side effects in 32 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 32 year old female

Reactions: Blood Calcium Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cymbalta
    Dosage: 60mg, unk

Cymbalta
    Dosage: unk, unknown



Possible Cymbalta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Suicide Attempt, Drug Withdrawal Syndrome, Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cymbalta
    Dosage: unk
    Start date: 2012-08-01

Cymbalta
    Dosage: 120 mg, qd
    Indication: Depression
    End date: 2012-01-01

Other drugs received by patient: Xanax



Possible Cymbalta side effects in 45 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 45 year old female

Reactions: Jaundice

Drug(s) suspected as cause:
Cymbalta

Other drugs received by patient: Oral Contraceptive NOS; Multivitamin



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 61 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 61 year old female

Reactions: Confusional State, Agitation, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Aspirin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Atorvastatin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bisoprolol Fumarate
    Dosage: 2.5-0-1.25
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Duragesic-100
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Nexium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Nitroglycerin
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-27

Plavix
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ramipril
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Zometa
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-19
    End date: 2012-07-19



Possible Cymbalta side effects in female

Reported by a physician from Germany on 2012-08-27

Patient: female

Reactions: Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Drug(s) suspected as cause:
Cymbalta
    Dosage: 30 mg, unknown
    Administration route: Oral
    Indication: Depression
    Start date: 2012-04-03
    End date: 2012-04-13

Cymbalta
    Dosage: 60 mg, unknown
    Start date: 2012-04-11
    End date: 2012-04-16

Other drugs received by patient: Metoprolol Tartrate; Metformin HCL; Fluvastatin Sodium; Diovan; Amlodipine Besylate; Aggrenox; Januvia; Sodium Chloride



Possible Cymbalta side effects in 47 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 47 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Pain, Oesophageal Rupture, Eye Pain, Weight Increased, Diplopia, Anxiety, Intervertebral Disc Disorder, Fibromyalgia, Visual Impairment, Depression, Multiple Sclerosis, Neck Surgery

Drug(s) suspected as cause:
Cymbalta
    Dosage: 60 mg, 2x/day
    Administration route: Oral
    Indication: Depression
    Start date: 2008-01-01
    End date: 2012-01-01

Cymbalta
    Dosage: 60 mg, daily
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2008-01-01

Halcion
    Dosage: 0.25 mg, 1x/day
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2006-01-01

Lyrica
    Dosage: 75 mg, 2x/day
    Indication: Fibromyalgia
    Start date: 2008-01-01
    End date: 2008-01-01

Lyrica
    Dosage: unk
    Administration route: Oral
    Start date: 2008-01-01
    End date: 2008-06-01

Rebif
    Dosage: unk, three days in a week
    Indication: Multiple Sclerosis
    Start date: 2008-07-01
    End date: 2009-07-01

Other drugs received by patient: Nuvigil; Copaxane; Furosemide; Hydrocodone; Creon 12000; Methocarbamol; Ventolin; Triazolam; Nexium; Naproxen; Ondansetron; Fluticasone Propionate; Triazolam; Furosemide; Levothyroxine Sodium; Hydrocodone Bitartrate and Ibuprofen; Fentanyl; Morphine; Levothyroxine Sodium; Hydrocodone Bitartrate + Acetaminophen; Lisinopril; Flexeril; Carafate; Nuvigil



Possible Cymbalta side effects in 70 year old male

Reported by a physician from United Kingdom on 2012-08-24

Patient: 70 year old male

Reactions: Syncope

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cymbalta

Zyprexa



Possible Cymbalta side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Cymbalta



Possible Cymbalta side effects in 33 year old male

Reported by a physician on 2012-08-24

Patient: 33 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Blood Bilirubin Increased

Drug(s) suspected as cause:
Cymbalta
    Dosage: daily
    Indication: Depression

Cymbalta
    Dosage: daily
    Indication: Insomnia

Cymbalta
    Dosage: daily
    Indication: Neuralgia



Possible Cymbalta side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: female

Reactions: Agitation, Confusional State, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Administration route: Oral

Atorvastatin
    Administration route: Oral

Bisoprolol Fumarate
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Administration route: Oral

Nitroglycerin
    End date: 2012-07-27

Plavix
    Administration route: Oral

Ramipril
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Start date: 2012-07-19
    End date: 2012-07-19



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 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 56 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 56 year old female

Reactions: Scab, Pain, Suicidal Ideation, Burning Sensation, Rash Erythematous, Vasculitis, Blister, Wound Necrosis, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cymbalta
    Dosage: 30 mg, unk
    Indication: Musculoskeletal Pain
    Start date: 2012-06-01

Cymbalta
    Dosage: 60 mg, unk
    End date: 2012-07-01

Other drugs received by patient: Dilaudid; Fentanyl; Santyl



Possible Cymbalta side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Pruritus, Nasopharyngitis, Oropharyngeal Pain, Cardiomegaly, Rheumatoid Arthritis, Incontinence, LOW Turnover Osteopathy, Back Disorder, Immunosuppression, Eye Pruritus, Haematuria, Macular Fibrosis, Macular Hole, Tonsillar Disorder, Increased Tendency To Bruise, Uterine Disorder, Rosacea, Muscle Disorder, Osteoporosis, Adverse Drug Reaction, Vitreous Detachment, Somnolence, Fall, Poor Quality Sleep, Tarsal Tunnel Syndrome, Nitrite Urine, Urosepsis, Rotator Cuff Syndrome, Depression, Exostosis, Macrocytosis, Vomiting, Haemorrhoids, Cardiac Infection, Alcohol Poisoning, Syncope, Lung Disorder, Arthralgia, Limb Asymmetry, Hypothyroidism, Gait Disturbance, Thrombosis, Femur Fracture, Wound, Urinary Incontinence, Lumbar Spinal Stenosis, Klebsiella Infection, Arthropathy, Adverse Event, Irritable Bowel Syndrome, Urinary Retention, Carpal Tunnel Syndrome, Radiculopathy, Intervertebral Disc Protrusion, Cellulitis, Breast Calcifications, Ankle Fracture, Insomnia, Stress Fracture, Drug Ineffective, Myalgia, Intervertebral Disc Disorder, Fibromyalgia, Device Component Issue, Nausea, Urinary Tract Infection, Cardiac Valve Vegetation, Synovitis, Adenoidal Disorder, Rash, Appendix Disorder, Intraocular Lens Implant, Osteoarthritis, Anxiety, Dysuria, Oral Disorder, Pollakiuria, Spinal Osteoarthritis, Spinal Claudication, Infection, Infusion Related Reaction

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Cymbalta
    Indication: Depression

Fosamax
    Dosage: unk
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2003-01-01

Fosamax
    Dosage: 35 mg, qw
    Administration route: Oral
    Start date: 2008-09-08

Fosamax
    Dosage: 35 mg, unk
    Administration route: Oral
    Start date: 2004-01-16
    End date: 2009-04-09

Other drugs received by patient: Meticorten; Bextra (Parecoxib Sodium); Hydroxychloroquine Sulfate; Triamcinolone; Atrexel; Leflunomide; Arava; MK-9039



Possible Cymbalta side effects in female

Reported by a physician from France on 2012-08-24

Patient: female

Reactions: Agitation, Confusional State, Acute Pulmonary Oedema, Nephrolithiasis, Dyspnoea, Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 mg, unk
    End date: 2012-07-26

Aspirin
    Dosage: 75 mg, unk

Atorvastatin
    Dosage: 10 mg, qd

Bisoprolol Fumarate
    Dosage: 3.75 mg, daily (2.5 mg in the morning and 1.25 mg in the evening)
    End date: 2012-07-27

Cymbalta
    Dosage: 60 mg, qd
    End date: 2012-07-26

Duragesic-100
    Dosage: 50 ug, daily
    End date: 2012-07-26

Lercanidipine
    Dosage: 10 mg, qd
    End date: 2012-07-26

Lyrica
    Dosage: 75 mg, bid
    End date: 2012-07-26

Nexium
    Dosage: 20 mg, qd
    End date: 2012-07-26

Nitroglycerin
    Dosage: 5 mg, daily
    End date: 2012-07-27

Plavix
    Dosage: 75 mg, qd
    End date: 2012-07-26

Ramipril
    Dosage: 10 mg, qd
    End date: 2012-07-26

Zometa
    Dosage: 4 mg, in 15 min
    Indication: Hypercalcaemia
    Start date: 2012-07-19



Possible Cymbalta side effects in female

Reported by a physician from France on 2012-08-24

Patient: female

Reactions: Confusional State, Nephrolithiasis, Acute Pulmonary Oedema, Agitation, Dyspnoea, Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 mg, unk
    End date: 2012-07-26

Aspirin
    Dosage: 75 mg, unk

Atorvastatin
    Dosage: 10 mg, qd

Bisoprolol Fumarate
    Dosage: 3.75 mg, daily (2.5 mg in the morning and 1.25 mg in the evening)
    End date: 2012-07-27

Cymbalta
    Dosage: 60 mg, qd
    End date: 2012-07-26

Duragesic-100
    Dosage: 50 ug, daily
    End date: 2012-07-26

Lercanidipine
    Dosage: 10 mg, qd
    End date: 2012-07-26

Lyrica
    Dosage: 75 mg, bid
    End date: 2012-07-26

Nexium
    Dosage: 20 mg, qd
    End date: 2012-07-26

Nitroglycerin
    Dosage: 5 mg, daily
    End date: 2012-07-27

Plavix
    Dosage: 75 mg, qd
    End date: 2012-07-26

Ramipril
    Dosage: 10 mg, qd
    End date: 2012-07-26

Zometa
    Dosage: 4 mg, in 15 min
    Indication: Hypercalcaemia
    Start date: 2012-07-19



Possible Cymbalta side effects in 50 year old female

Reported by a physician from United States on 2012-08-24

Patient: 50 year old female

Reactions: Malabsorption, Anxiety, Depression, Mesothelioma Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cymbalta

Other drugs received by patient: Clonazepam; Neurontin; Multivitamin; Synthroid; Lonox; Lexapro; Vitamin D; Lortab



Possible Cymbalta side effects in 31 year old female

Reported by a physician from United States on 2012-08-24

Patient: 31 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Hypertensive Crisis

Drug(s) suspected as cause:
Cymbalta



Possible Cymbalta side effects in female

Reported by a physician from France on 2012-08-24

Patient: female

Reactions: Nephrolithiasis, Agitation, Confusional State, Acute Pulmonary Oedema, Dyspnoea, Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 mg, unk
    End date: 2012-07-26

Aspirin
    Dosage: 75 mg, unk

Atorvastatin
    Dosage: 10 mg, qd

Bisoprolol Fumarate
    Dosage: 3.75 mg, daily (2.5 mg in the morning and 1.25 mg in the evening)
    End date: 2012-07-27

Cymbalta
    Dosage: 60 mg, qd
    End date: 2012-07-26

Duragesic-100
    Dosage: 50 ug, daily
    End date: 2012-07-26

Lercanidipine
    Dosage: 10 mg, qd
    End date: 2012-07-26

Lyrica
    Dosage: 75 mg, bid
    End date: 2012-07-26

Nexium
    Dosage: 20 mg, qd
    End date: 2012-07-26

Nitroglycerin
    Dosage: 5 mg, daily
    End date: 2012-07-27

Plavix
    Dosage: 75 mg, qd
    End date: 2012-07-26

Ramipril
    Dosage: 10 mg, qd
    End date: 2012-07-26

Zometa
    Dosage: 4 mg, in 15 min
    Indication: Hypercalcaemia
    Start date: 2012-07-19



Possible Cymbalta side effects in 36 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-24

Patient: 36 year old male

Reactions: Accident, Surgery, Depressed Level of Consciousness, Drug Withdrawal Syndrome, Headache, Intentional Drug Misuse, Vertigo Positional

Drug(s) suspected as cause:
Cymbalta

Other drugs received by patient: Anaesthetics



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 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 36 year old female

Reactions: Nausea, Dizziness, Headache, Withdrawal Syndrome, Feeling Abnormal

Drug(s) suspected as cause:
Cymbalta
    Indication: Depression

Cymbalta
    Dosage: 60 mg, daily
    Indication: Anxiety

Effexor XR
    Dosage: unk
    Indication: Anxiety
    Start date: 2003-02-01

Effexor XR
    Dosage: 37.5 mg, daily
    End date: 2012-08-01

Effexor XR
    Dosage: 300 mg, daily
    Indication: Depression



Possible Cymbalta side effects in 26 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-23

Patient: 26 year old female

Reactions: Complication of Delivery, Maternal Exposure During Pregnancy, Haemorrhage in Pregnancy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cymbalta
    Dosage: 120 mg, qd

Cymbalta
    Dosage: 90 mg, unk

Cymbalta
    Dosage: 60 mg, unk
    Indication: Depression

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