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Ultracet (Tramadol / Acetaminophen) - Side Effect Reports to FDA

 
 



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, 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 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 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: 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 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 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 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 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 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 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 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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