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Itchy Skin (163)
Nausea (75)
Loss Of Memory (59)
Sleeplessness (50)
Pain (41)
Swelling (36)
Severe Hoarseness (34)
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Tramadol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 3658 

Osteoarthritis, Dizziness, Nausea (8455335-2)
on Jun 13, 2012 Female from JAPAN , 65 years of age, was diagnosed with
  • pain
and was treated with Tramadol Hcl. Directly after, patient experienced the unwanted or unexpected Tramadol side effects: osteoarthritis, dizziness, nausea. Tramadol Hcl dosage: 4 Per 1 Day. Patient was hospitalized.

Paraparesis, Withdrawal Syndrome, Dyskinesia (8455294-2)
Patient was taking Tramadol Hcl. Patient felt the following Tramadol side effects: paraparesis, withdrawal syndrome, dyskinesia on Jun 11, 2012 from FRANCE Additional patient health information: Male , 63 years of age, was diagnosed with
  • arthralgia
and. Tramadol Hcl dosage: N/A.
Multiple prescriptions taken:
  • Acetaminophen And Tramadol Hcl


Insomnia, Nausea, Dizziness, Hypoaesthesia, Tinnitus (8454666-X)
Adverse event was reported on Jun 15, 2012 by a Female taking Tramadol Hcl (Dosage: 1 Tablet 4 Times Daily Buccal On And Off 1 Month) was diagnosed with
  • intervertebral disc protrusion
and. Location: UNITED STATES , 34 years of age, weighting 128.0 lb, After Tramadol was administered, patient encountered several Tramadol side effects: insomnia, nausea, dizziness, hypoaesthesia, tinnitus.

Complex Regional Pain Syndrome (8451790-2)
on Jun 07, 2012 Female from UNITED STATES , 39 years of age, weighting 250.0 lb, was treated with Tramadol Hcl. Directly after, patient experienced the unwanted or unexpected Tramadol side effects: complex regional pain syndrome. Tramadol Hcl dosage: N/A.
Associated medications used:
  • Depakote Er
  • Zoloft
  • Hydrocodone
  • Wellbutrin Sr
  • Methylthenid
  • Seroquel Xr
  • Lyrica



Asthenia, Decreased Appetite, Haemoglobin Decreased, Vomiting, Anal Pruritus, Anorectal Discomfort, Fatigue (8451611-8)
on Mar 27, 2012 Female from UNITED STATES , weighting 192.2 lb, was diagnosed with
  • anxiety
  • hepatitis c
and was treated with Tramadol Hcl. Patient felt the following Tramadol side effects: asthenia, decreased appetite, haemoglobin decreased, vomiting, anal pruritus, anorectal discomfort, fatigue. Tramadol Hcl dosage: N/A.
Multiple prescriptions taken:
  • Ribavirin
  • Ribavirin
  • Hydrochlorothiazide
  • Pegasys
  • Incivek


Ileus (8447067-1)
Patient was taking Tramadol Hcl. After Tramadol was administered, patient encountered several Tramadol side effects: ileus on Jun 15, 2012 from NETHERLANDS Additional patient health information: Male , 42 years of age, was diagnosed with
  • arthralgia
and. Tramadol Hcl dosage: N/A. Patient was hospitalized.

Pain, Gastrooesophageal Reflux Disease (8445416-1)
Adverse event was reported on Jun 15, 2012 by a Female taking Tramadol (Dosage: 50 Mg, 4x/day) was diagnosed with
  • pain
  • insomnia
  • depression
  • fibromyalgia
  • irritable bowel syndrome
and. Location: UNITED STATES , weighting 110.0 lb, Directly after, patient experienced the unwanted or unexpected Tramadol side effects: pain, gastrooesophageal reflux disease.
Associated medications used:
  • Trazodone (50 Mg, Daily)
  • Cymbalta (20 Mg, 2x/day)
  • Lyrica (75 Mg, 3x/day)
  • Dicyclomine (20 Mg, 4x/day)


Pyrexia (8445310-6)
on Jun 18, 2012 Female from JAPAN , 91 years of age, was diagnosed with
  • pain
and was treated with Tramadol Hydrochloride And Acetaminophen. Patient felt the following Tramadol side effects: pyrexia. Tramadol Hydrochloride And Acetaminophen dosage: One Per One Day At Bedtime.

Aspartate Aminotransferase Increased, Gamma-glutamyltransferase Increased, Eosinophilia, Cholestasis, Blood Alkaline Phosphatase Increased, Hypersensitivity, Alanine Aminotransferase Increased, Cytolytic Hepatitis (8445058-8)
on Jun 11, 2012 Female from FRANCE , 77 years of age, was treated with Tramadol Hcl. After Tramadol was administered, patient encountered several Tramadol side effects: aspartate aminotransferase increased, gamma-glutamyltransferase increased, eosinophilia, cholestasis, blood alkaline phosphatase increased, hypersensitivity, alanine aminotransferase increased, cytolytic hepatitis. Tramadol Hcl dosage: N/A.
Multiple concurrent drugs taken:
  • Tracleer (Unk)
  • Revatio (Unk)
  • Lasix
  • Tracleer (Unk)
  • Imodium
  • Acetaminophen
  • Potassium Chloride
Patient was hospitalized.

Osteonecrosis Of Jaw, Foot Deformity, Arthralgia, Musculoskeletal Pain (8440633-9)
Patient was taking Tramadol Hydrochloride. Directly after, patient experienced the unwanted or unexpected Tramadol side effects: osteonecrosis of jaw, foot deformity, arthralgia, musculoskeletal pain on May 31, 2012 from FRANCE Additional patient health information: Female , 69 years of age, was diagnosed with
  • arthralgia
  • osteoporosis
and. Tramadol Hydrochloride dosage: N/A.
Associated medications used:
  • Fosamax Plus D
  • Diazepam
  • Fosamax
Patient was hospitalized and became disabled.

Heart Rate Increased, Chest Pain, Throat Irritation (8440242-1)
Adverse event was reported on Jun 07, 2012 by a Female taking Tramadol Hcl (Dosage: Take 1 To 2 Tablets 3 Times As Needed) . Location: UNITED STATES , weighting 1105 lb, Patient felt the following Tramadol side effects: heart rate increased, chest pain, throat irritation.
Multiple prescriptions taken:
  • Prozac
  • Gabapentin (Capsule 2 Oral Three Times Daily)
  • Prednisone Tab (Tablet 3 Oral Daily)
  • Hydroxychloroquine Sulfate
  • Prempro (0.3 - 1.5 Tablet)
  • Lovaza (350 Capsule 1 Twice Oral Daily)
  • Celebrex
  • Prednisone Tab (Take 1 Tablet Twice A Daily)


Toe Amputation, Varicose Ulceration, Sepsis, Klebsiella Infection, Neutropenia (8439729-7)
on Jun 04, 2012 Male from FRANCE , 68 years of age, was treated with Tramadol Hcl. After Tramadol was administered, patient encountered several Tramadol side effects: toe amputation, varicose ulceration, sepsis, klebsiella infection, neutropenia. Tramadol Hcl dosage: Unk.
Multiple concurrent drugs taken:
  • Rocephin (Unk)
  • Pantoprazole Sodium (40 Mg, Daily)
  • Tenormin (Unk)
  • Lyrica (Unk)
  • Paracetamol (Unk)
  • Iron (Unk)
  • Kayexalate (Unk)
  • Orbenin Cap (Unk)


Anaemia, Diarrhoea, Duodenal Ulcer Haemorrhage, Dyspnoea Exertional, Decreased Appetite, Fatigue, Weight Decreased, Vomiting (8439516-X)
on Jun 08, 2012 Male from ITALY , 39 years of age, was treated with Tramadol Hcl. Directly after, patient experienced the unwanted or unexpected Tramadol side effects: anaemia, diarrhoea, duodenal ulcer haemorrhage, dyspnoea exertional, decreased appetite, fatigue, weight decreased, vomiting. Tramadol Hcl dosage: Unk.
Associated medications used:
  • Eperisone Hydrochloride (Unk)
  • Lyrica (Unk)
  • Tachidol (Unk)
  • Acetaminophen (Unk)
Patient was hospitalized.

Disturbance In Attention, Self-injurious Ideation, Sleep Disorder, Anxiety, Panic Attack (8438919-7)
Patient was taking Tramadol Hcl. Patient felt the following Tramadol side effects: disturbance in attention, self-injurious ideation, sleep disorder, anxiety, panic attack on Jun 05, 2012 from GERMANY Additional patient health information: Female , 29 years of age, was diagnosed with
  • fibromyalgia
and. Tramadol Hcl dosage: 2 Doses Per Day.
Multiple prescriptions taken:
  • Amitriptyline Hcl (10 Mg Once Daily)


Constipation, Withdrawal Syndrome, Malaise, Palpitations, Hyperhidrosis (8438918-5)
Adverse event was reported on Jun 06, 2012 by a Female taking Tramadol Hydrochloride/acetaminophen (Dosage: 8 Doses X 1 Per 1 Day) . Location: JAPAN , weighting 145.5 lb, After Tramadol was administered, patient encountered several Tramadol side effects: constipation, withdrawal syndrome, malaise, palpitations, hyperhidrosis.
Multiple concurrent drugs taken:
  • Fentanyl-100
  • Lyrica
  • Amitriptyline Hydrochloride
  • Magmitt


Insomnia, Myalgia (8437771-3)
on Apr 05, 2012 Female from UNITED STATES , 83 years of age, was treated with Tramadol Hcl. Directly after, patient experienced the unwanted or unexpected Tramadol side effects: insomnia, myalgia. Tramadol Hcl dosage: N/A.
Associated medications used:
  • Celebrex
  • Prolia (Unk)


Epilepsy, Ileectomy (8436028-4)
on Jun 05, 2012 Male from SLOVENIA , weighting 163.1 lb, was diagnosed with
  • pain
  • crohn's disease
  • epilepsy
and was treated with Tramadol Hydrochloride. Patient felt the following Tramadol side effects: epilepsy, ileectomy. Tramadol Hydrochloride dosage: 36 Ggts If Pain Appears.
Multiple prescriptions taken:
  • Humira
  • Lamictal
  • Humira


Gingival Bleeding, Gingival Disorder, Headache, Loose Tooth, Bone Pain, Diplegia, Abdominal Discomfort (8435929-0)
Patient was taking Tramadol Hcl. After Tramadol was administered, patient encountered several Tramadol side effects: gingival bleeding, gingival disorder, headache, loose tooth, bone pain, diplegia, abdominal discomfort on Jun 07, 2012 from FRANCE Additional patient health information: Female , 54 years of age, . Tramadol Hcl dosage: N/A.
Multiple concurrent drugs taken:
  • Boniva
  • Boniva
  • Oxazepam
  • Cymbalta
  • Omeprazole


Miosis, Inappropriate Antidiuretic Hormone Secretion, Somnolence, Hyponatraemia, Respiratory Failure (8435574-7)
Adverse event was reported on Jun 04, 2012 by a Male taking Tramadol Hcl (Dosage: 3 Gram; 60x50mg) . Location: UNITED KINGDOM , 56 years of age, Directly after, patient experienced the unwanted or unexpected Tramadol side effects: miosis, inappropriate antidiuretic hormone secretion, somnolence, hyponatraemia, respiratory failure.
Associated medications used:
  • Co-dydramol (20x10mg Dihydrocodeine/20x500mg Paracetamol)
  • Fluticasone Propionate/salmeterol
  • Spiriva
Patient was hospitalized.

Traumatic Lung Injury, Road Traffic Accident, Weight Increased (8433805-0)
on Jun 11, 2012 Female from UNITED STATES , weighting 153.0 lb, was diagnosed with
  • back disorder
  • fibromyalgia
and was treated with Tramadol. Patient felt the following Tramadol side effects: traumatic lung injury, road traffic accident, weight increased. Tramadol dosage: 50 Mg, 4x/day.
Multiple prescriptions taken:
  • Lyrica (225 Mg, 2x/day)
  • Lyrica (225 Mg, 2x/day)
  • Klonopin (1 Mg, 4x/day)
  • Lyrica (Unk)
  • Abilify (10 Mg, 2x/day)
Patient was hospitalized.

Activities Of Daily Living Impaired, Asthenia, Fatigue, Malaise, Injection Site Reaction (8432572-4)
on May 31, 2012 Female from UNITED STATES , 52 years of age, weighting 180.0 lb, was treated with Tramadol Hcl. After Tramadol was administered, patient encountered several Tramadol side effects: activities of daily living impaired, asthenia, fatigue, malaise, injection site reaction. Tramadol Hcl dosage: Unk.
Multiple concurrent drugs taken:
  • Enbrel (50 Mg, Weekly)
  • Enbrel
  • Cymbalta (Unk)
  • Voltaren (Unk)
  • Omeprazole (Unk)
  • Betamethasone Dipropionate (Unk)
  • Potassium (Unk)
  • Verapamil (Unk)


Osteoarthritis, Upper Limb Fracture, Vitamin D Deficiency, Calcium Deficiency, Ulna Fracture, Osteoporosis, Neuropathic Arthropathy, Emotional Distress, Androgen Deficiency (8432460-3)
Patient was taking Tramadol Hcl. Directly after, patient experienced the unwanted or unexpected Tramadol side effects: osteoarthritis, upper limb fracture, vitamin d deficiency, calcium deficiency, ulna fracture, osteoporosis, neuropathic arthropathy, emotional distress, androgen deficiency on Jun 05, 2012 from UNITED STATES Additional patient health information: Male , 62 years of age, was diagnosed with
  • pain
and. Tramadol Hcl dosage: N/A.
Associated medications used:
  • Prilosec
  • Hydrocodone
  • Actos
  • Nexium
  • Prilosec
  • Flomax
  • Cyclobenzaprine
  • Amaryl
Patient was hospitalized.

Convulsion (8431749-1)
Adverse event was reported on Jun 07, 2012 by a Male taking Tramadol Hcl (Dosage: 100 Mg Tid Po) was diagnosed with
  • convulsion
and. Location: UNITED STATES , 54 years of age, weighting 241.4 lb, Patient felt the following Tramadol side effects: convulsion.
Multiple prescriptions taken:
  • Sertraline Hydrochloride (100 Mg Am Po)


Gastric Ulcer, Inadequate Analgesia (8431710-7)
on Jun 05, 2012 Male from JAPAN , weighting 143.3 lb, was diagnosed with
  • pain
and was treated with Tramadol Hydrochloride And Acetaminophen. After Tramadol was administered, patient encountered several Tramadol side effects: gastric ulcer, inadequate analgesia. Tramadol Hydrochloride And Acetaminophen dosage: 1 Per Day.
Multiple concurrent drugs taken:
  • Mecobalamin (1500 Ug X 1 Per 1 Day)
  • Amlodipine Besylate (5 Mg X 1 Per 1 Day)


Pulmonary Infarction, Pulmonary Embolism (8431474-7)
on Jun 05, 2012 Female from UNITED STATES , 20 years of age, weighting 125.7 lb, was diagnosed with
  • pain
and was treated with Tramadol Hcl. Directly after, patient experienced the unwanted or unexpected Tramadol side effects: pulmonary infarction, pulmonary embolism. Tramadol Hcl dosage: 50 Mg, Qd. Patient was hospitalized.

Showing 1-25 of 3658 

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How Can Tramadol Affect You?

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Tramadol Information

Alternative TRAMADOL Names:CONZIP RYBIX RYZOLT SYNAPRYN TRAMAPAP ULTRACET ULTRAM ULTRAM ER

Active Ingredient: ACETAMINO TRAMADOL

More About Tramadol

Side Effects reported to FDA: 3658. View Tramadol Adverse Reports

Tramadol safety alerts: 2010

Reported deaths: 485

Reported hospitalizations: 1030

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

Audience: Pain management healthcare professionals

[Posted 05/25/2010] Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs and also warns of the risk of overdosage. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. Tramadol has mu-opioid agonist activity, can be abused and may be subject to criminal diversion.

[April 2010 - Dear Healthcare Professional Letter: Ultram - Ortho-McNeil-Janssen]
[April 2010 - Dear Healthcare Professional Letter: Ultracet - Ortho-McNeil-Janssen]

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