This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ultracet (Tramadol / Acetaminophen) 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 (55)
Death (3)
Life Threatening Events (13)
Reports by Reaction Type
Dizziness (13),
Vomiting (7),
Fall (5),
Rhabdomyolysis (4),
Drug Ineffective (4),
Somnolence (4),
Loss of Consciousness (4),
Delirium (4),
Hypercreatininaemia (3),
Unresponsive To Stimuli (3),
Drug Interaction (3),
Multiple Drug Overdose (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Ultracet (Tramadol / Acetaminophen). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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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