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

 
 



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 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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