Index of reports
> All Cases (55)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ultracet (Tramadol / Acetaminophen) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 55 Next >>
Possible Ultracet side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-23
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Ultracet
Possible Ultracet side effects in 44 year old male
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: 44 year old male, weighing 74.0 kg (162.8 pounds)
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Lidocaine
Dosage: unk
Indication: Pain
Aleve
Dosage: unk, as needed
Indication: Pain
Advil
Dosage: 400 mg to 800 mg as needed
Indication: Pain
Ultracet
Dosage: 37.5 mg, 2x/day
Indication: Pain
Other drugs received by patient: Nasonex
Possible Ultracet side effects in male
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-07-06
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Gastrointestinal Haemorrhage, Peptic Ulcer, Constipation, Faeces Discoloured, Abdominal Discomfort, Dizziness, Abdominal Distension, Epistaxis
Drug(s) suspected as cause:
Ultracet
Administration route: Oral
Indication: Postoperative Analgesia
Start date: 2010-03-04
Morphine
Indication: Postoperative Analgesia
Start date: 2010-03-04
Diclofenac Sodium
Indication: Postoperative Analgesia
Start date: 2010-03-04
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from China on 2012-06-12
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Hypoglycaemia, Drug Interaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ultracet
Dosage: 3 tablets in a day/(acetaminophen 325 mg tramadol hcl 37.5 mg)
Administration route: Oral
Indication: Tenosynovitis
Start date: 2011-06-22
End date: 2011-06-24
Ultracet
Dosage: 3 tablets in a day/(acetaminophen 325 mg tramadol hcl 37.5 mg)
Administration route: Oral
Indication: Pain
Start date: 2011-06-22
End date: 2011-06-24
Other drugs received by patient possibly interacting with the suspect drug: Insulin
Indication: Diabetes Mellitus
Possible Ultracet side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-06-01
Patient: 73 year old female
Reactions: Rhabdomyolysis, Hypercreatininaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-03-08
End date: 2011-12-13
Pantoprazole
Administration route: Oral
Indication: Prophylaxis
Start date: 2011-07-11
End date: 2011-12-13
Fluvastatin
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2011-03-09
End date: 2011-12-13
Ultracet
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-07-01
End date: 2011-12-13
Escitalopram
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-11-07
End date: 2011-12-13
Tramadol HCL
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-12-07
End date: 2011-12-13
Possible Ultracet side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-31
Patient: 73 year old female
Reactions: Rhabdomyolysis, Hypercreatinaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Depakene
Dosage: 400 mg
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-03-08
End date: 2011-12-13
Pantoprazole
Dosage: 40 mg
Administration route: Oral
Indication: Prophylaxis
Start date: 2011-07-11
End date: 2011-12-13
Ultracet
Dosage: 3 df
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-07-01
End date: 2011-12-13
Escitalopram
Dosage: 5 mg
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-11-07
End date: 2011-12-13
Fluvastatin
Dosage: 80 mg
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2011-03-09
End date: 2011-12-13
Tramadol HCL
Dosage: 150 mg
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-12-07
End date: 2011-12-13
Possible Ultracet side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-05-31
Patient: 69 year old male
Reactions: Death, Chest Pain, International Normalised Ratio Increased, Muscular Weakness, Drug Interaction, Haemorrhagic Diathesis, Oedema
Adverse event resulted in: death
Drug(s) suspected as cause:
Ultracet
Other drugs received by patient possibly interacting with the suspect drug: Warfarin Sodium
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Gemcitabine
Possible Ultracet side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-05-29
Patient: 73 year old female
Reactions: Rhabdomyolysis, Hypercreatininaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Escitalopram
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-11-07
End date: 2011-12-13
Tramadol HCL
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-12-07
End date: 2011-12-13
Depakene
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-03-08
End date: 2011-12-13
Ultracet
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-07-01
End date: 2011-12-13
Pantoprazole
Administration route: Oral
Indication: Prophylaxis
Start date: 2011-07-11
End date: 2011-12-13
Fluvastatin
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2011-03-09
End date: 2011-12-13
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from China on 2012-05-22
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Vomiting, Unresponsive To Stimuli, Lethargy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ultracet
Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
Administration route: Oral
Indication: Intervertebral Disc Protrusion
Start date: 2011-05-10
End date: 2011-05-10
Ultracet
Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
Administration route: Oral
Indication: Pain in Extremity
Start date: 2011-05-10
End date: 2011-05-10
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from China on 2012-05-18
Patient: female
Reactions: Cardiac Discomfort, Dizziness, Cold Sweat
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ultracet
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from China on 2012-05-18
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Vomiting, Unresponsive To Stimuli, Lethargy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ultracet
Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
Administration route: Oral
Indication: Pain in Extremity
Start date: 2011-05-10
End date: 2011-05-11
Ultracet
Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
Administration route: Oral
Indication: Intervertebral Disc Protrusion
Start date: 2011-05-10
End date: 2011-05-11
Possible Ultracet side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-18
Patient: 73 year old female
Reactions: Rhabdomyolysis, Hypercreatininaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Escitalopram
Dosage: 5 mg
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-11-07
End date: 2011-12-13
Ultracet
Dosage: 3 df
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-07-01
End date: 2011-12-13
Pantoprazole
Dosage: 40 mg
Administration route: Oral
Indication: Prophylaxis
Start date: 2011-07-11
End date: 2011-12-13
Tramadol Hydrochloride
Dosage: 150 mg
Administration route: Oral
Indication: Osteoarthritis
Start date: 2011-12-07
End date: 2011-12-13
Depakene
Dosage: 400 mg
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2011-03-08
End date: 2011-12-13
Fluvastatin
Dosage: 80 mg
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2011-03-09
End date: 2011-12-13
Possible Ultracet side effects in 83 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-15
Patient: 83 year old female
Reactions: Agitation, Confusional State, Aggression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mirtazapine
Dosage: 15 mg;qd;po
Administration route: Oral
Indication: Major Depression
Start date: 2012-03-06
End date: 2012-03-21
Ultracet
Dosage: po
Administration route: Oral
Indication: Pain
Start date: 2012-03-06
End date: 2012-03-21
Other drugs received by patient: Propranolol; Lorazepam; Calcium Carbonate; Levothyroxine Sodium; Motilium; Amlodipine Besylate
Possible Ultracet side effects in female
Reported by a physician from United States on 2012-05-04
Patient: female
Reactions: Vomiting, Nausea, Drug Hypersensitivity
Drug(s) suspected as cause:
Celebrex
Dosage: unk
Keflex
Dosage: unk
Ultracet
Dosage: unk
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from China on 2012-05-02
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Blood Glucose Decreased, Palpitations, Hypoglycaemia, Sweat Gland Disorder, Drug Interaction, Dizziness
Drug(s) suspected as cause:
Ultracet
Dosage: 3 tablets in a day/(acetaminophen 325 mg tramadol hcl 37.5 mg)
Administration route: Oral
Indication: Tenosynovitis
Start date: 2011-06-22
End date: 2011-06-24
Ultracet
Dosage: 3 tablets in a day/(acetaminophen 325 mg tramadol hcl 37.5 mg)
Administration route: Oral
Indication: Pain
Start date: 2011-06-22
End date: 2011-06-24
Other drugs received by patient possibly interacting with the suspect drug: Insulin
Indication: Diabetes Mellitus
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from China on 2012-05-02
Patient: female
Reactions: Cardiac Discomfort, Dizziness, Cold Sweat
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ultracet
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from China on 2012-05-02
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Vomiting, Unresponsive To Stimuli, Lethargy
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ultracet
Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
Administration route: Oral
Indication: Pain in Extremity
Start date: 2011-05-10
End date: 2011-05-11
Ultracet
Dosage: 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol 1 per day
Administration route: Oral
Indication: Intervertebral Disc Protrusion
Start date: 2011-05-10
End date: 2011-05-11
Possible Ultracet side effects in male
Reported by a physician from China on 2012-05-02
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Dysstasia, Chest Discomfort, Body Temperature Increased, Muscle Twitching, Hyperhidrosis, Pallor, Cardiac Arrest, Shock
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ultracet
Dosage: one tablet 3 times daily
Administration route: Oral
Indication: Intervertebral Disc Protrusion
Start date: 2011-05-16
End date: 2011-05-18
Ultracet
Dosage: one tablet 3 times daily
Administration route: Oral
Indication: Back Pain
Start date: 2011-05-16
End date: 2011-05-18
Other drugs received by patient: Unknown Medication; Unknown Medication; Unknown Medication
Possible Ultracet side effects in 46 year old female
Reported by a pharmacist from Thailand on 2012-04-23
Patient: 46 year old female
Reactions: Chest Discomfort, Vomiting, Rash Generalised
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ultracet
Administration route: Oral
Indication: Pain
Start date: 2012-03-13
End date: 2012-03-15
Unasyn
Administration route: Oral
Indication: Infection
Start date: 2012-03-13
End date: 2012-03-15
Possible Ultracet side effects in 47 year old female
Reported by a consumer/non-health professional from Brazil on 2012-04-17
Patient: 47 year old female
Reactions: Migraine, Condition Aggravated, Drug Administration Error, Cerebrovascular Accident, Hypertension
Drug(s) suspected as cause:
Acetaminophen, Aspirin and Caffeine
Dosage: 1 df, prn, more than 10 years
Administration route: Oral
Indication: Headache
Pamelor
Dosage: 75 mg, qd, from 6 months ago
Indication: Feeling of Relaxation
Tramadol HCL
Dosage: 1 df, q6h, from a long time ago
Indication: Pain
Aspirin
Dosage: unk, unk
Ketoprofen
Dosage: 1 df, qw, from a long time ago
Indication: Pain
Candesartan Cilexetil
Dosage: 16 mg, bid from one year ago
Indication: Hypertension
Start date: 2011-01-01
Amlodipine Besylate
Dosage: 5 mg, unk
Ultracet
Dosage: 1 df, q12h, from a long time ago
Indication: Pain
Possible Ultracet side effects in 66 year old female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-04-13
Patient: 66 year old female
Reactions: Delirium
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ultracet
Indication: Pain Management
Diclofenac Sodium
Dosage: 25-jun
Indication: Pain Management
Possible Ultracet side effects in female
Reported by a physician from United States on 2012-03-29
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Topamax
Dosage: unk
Ultracet
Dosage: unk
Vicodin
Dosage: unk
Erythromycin
Dosage: unk
Codeine
Dosage: unk
Penicillin G Potassium
Dosage: unk
Keflex
Dosage: unk
Possible Ultracet side effects in 46 year old female
Reported by a pharmacist from Thailand on 2012-03-29
Patient: 46 year old female
Reactions: Chest Discomfort, Rash Generalised, Vomiting
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Unasyn
Administration route: Oral
Indication: Infection
Start date: 2012-03-13
End date: 2012-03-15
Ultracet
Administration route: Oral
Indication: Pain
Start date: 2012-03-13
End date: 2012-03-15
Possible Ultracet side effects in 84 year old female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-03-23
Patient: 84 year old female, weighing 42.0 kg (92.4 pounds)
Reactions: Pneumonia Aspiration, Neurogenic Bladder, Vomiting, Toxic Encephalopathy, Delirium, Loss of Consciousness, Convulsion, Insomnia, Urinary Retention, Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperidone
Indication: Insomnia
Ultracet
Administration route: Oral
Indication: Pain Management
Possible Ultracet side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-03-23
Patient: 56 year old male
Reactions: Drug Eruption
Drug(s) suspected as cause:
Ultracet
Dosage: 1 df twice daily
Administration route: Oral
Indication: Intervertebral Disc Degeneration
Start date: 2011-03-21
Ultracet
Dosage: 1 df twice daily
Administration route: Oral
Indication: Pain
Start date: 2011-03-21
Other drugs received by patient: Magnesium Oxide; Alinamin F; Alinamin F; Magnesium Oxide
Possible Ultracet side effects in 66 year old female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-03-23
Patient: 66 year old female
Reactions: Delirium
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diclofenac Sodium
Dosage: 25-jun
Indication: Pain Management
Ultracet
Indication: Pain Management
Possible Ultracet side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-14
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Vicodin
Dosage: unk
Potassium Penicillin G
Dosage: unk
Keflex
Dosage: unk
Codeine Sulfate
Dosage: unk
Ultracet
Dosage: unk
Erythromycin
Dosage: unk
Topamax
Dosage: unk
Possible Ultracet side effects in 56 year old female
Reported by a consumer/non-health professional from China on 2012-03-01
Patient: 56 year old female
Reactions: Retching, Skin Discolouration, Palpitations, Nausea, Diarrhoea, Asthenia, Somnolence
Drug(s) suspected as cause:
Ultracet
Other drugs received by patient: Celecoxib
Possible Ultracet side effects in male
Reported by a physician from Korea, Republic of on 2012-02-23
Patient: male, weighing 65.2 kg (143.4 pounds)
Reactions: Dizziness, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ultracet
Dosage: one tablet twice a day.
Administration route: Oral
Indication: Pain
Start date: 2011-10-27
End date: 2011-11-21
Ultracet
Dosage: decreased dose to half (1 tablet twice a day)
Administration route: Oral
Other drugs received by patient: Soleton; Afloqualone; Mucosta; Paramacet; Lyrica; Lidocaine; Triamcinolone Diacetate
Possible Ultracet side effects in female
Reported by a physician from Korea, Republic of on 2012-02-15
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Loss of Consciousness
Drug(s) suspected as cause:
Ultracet
Other drugs received by patient: Stillen; Stillen; Opalmon
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