"Despite being at the front lines in the nation's battle against opioid addiction as the first to treat chronic pain, and opioid overuse, few primary care and family physicians use the one drug available to them to treat addiction, buprenorphine, "...
Ultracet Side Effects Center
Pharmacy Editor: Eni Williams, PharmD, PhD
Ultracet (tramadol and acetaminophen) is a combination medication belonging to the drug class known as nonopiod analgesic. Ultracet is prescribed for the short-term relief of moderate to moderately-severe pain. Common side effects of Ultracet include constipation, tiredness, increased sweating, dizziness, drowsiness, weakness, stomach pain, loss of appetite, dry mouth, blurred vision, nervousness, anxiety, itching, and sleep problems (insomnia).
Ultracet usual adult dose is 2 tablets every 4-6 hours as need for pain, up to 8 tablets maximum a day. Drug interactions include carbamazepine (Tegretol), isoniazid, rifampin, and quinidine. There are no adequate studies of Ultracet in pregnant women and Ultracet is secreted in human breast milk. Safety in nursing mothers has not been established.
Our Ultracet Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. articles.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ultracet in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using acetaminophen and tramadol and call your doctor at once if you have any of these serious side effects:
- seizure (convulsions);
- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
- a red, blistering, peeling skin rash; or
- shallow breathing, weak pulse.
Less serious side effects may include:
- dizziness, drowsiness, weakness, tired feeling;
- stomach pain, constipation, loss of appetite;
- dry mouth, blurred vision;
- feeling nervous or anxious;
- sweating, itching; or
- sleep problems (insomnia).
Read the entire detailed patient monograph for Ultracet (Tramadol Hydrochloride and Acetaminophen Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Ultracet Overview - Patient Information: Side Effects
Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or sweating may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.
Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Ultracet (Tramadol Hydrochloride and Acetaminophen Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ultracet FDA Prescribing Information: Side Effects
Table 2 reports the incidence rate of treatment-emergent adverse events over five days of ULTRACET® use in clinical trials (subjects took an average of at least 6 tablets per day).
Table 2: Incidence of Treatment-Emergent Adverse
Events ( ≥ 2.0%)
|Body System Preferred Term||ULTRACET®
|Gastrointestinal System Disorders|
|Central & Peripheral Nervous System|
|Skin and Appendages|
|Reproductive Disorders, Male *|
|* Number of males = 62|
Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET®.
Body as a Whole - Asthenia, fatigue, hot flushes
Central and Peripheral Nervous System - Dizziness, headache, tremor
Skin and Appendages - Pruritus, rash, increased sweating
Selected Adverse events occurring at less than 1%: the following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET® clinical trials.
Body as a Whole - Chest pain, rigors, syncope, withdrawal syndrome
Hearing and Vestibular Disorders - Tinnitus
Liver and Biliary System - Hepatic function abnormal
Metabolic and Nutritional Disorders - Weight decrease
Red Blood Cell Disorders - Anemia
Respiratory System - Dyspnea
Vision Disorders - Abnormal vision
Other Clinically Significant Adverse Experiences Previously Reported With Tramadol Hydrochloride
Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, orthostatic hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis, liver failure, and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures, and coma) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs.
Other Clinically Significant Adverse Experiences Previously Reported With Acetaminophen
Allergic reactions (primarily skin rash) or reports of hypersensitivity secondary to acetaminophen are rare and generally controlled by discontinuation of the drug and, when necessary, symptomatic treatment.
Drug Abuse And Dependence
Tramadol has mu-opioid agonist activity. ULTRACET®, a tramadol-containing product, can be abused and may be subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Drug addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, continued use despite harm or risk of harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of ULTRACET® can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.
Concerns about abuse and addiction should not prevent the proper management of pain. However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of this product.
ULTRACET® is intended for oral use only.
Tolerance is the need for increasing doses of drugs to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist (see also WARNINGS, Withdrawal).
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with ULTRACET®.
Read the entire FDA prescribing information for Ultracet (Tramadol Hydrochloride and Acetaminophen Tablets)
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Report Problems to the Food and Drug Administration
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.
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