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Tramadol Hydrochloride and Acetaminophen
Overview
What is Tramadol Hydrochloride and Acetaminophen?
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, combines two analgesics, tramadol and acetaminophen.
The chemical name for tramadol hydrochloride is (±)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
The molecular weight of tramadol hydrochloride is 299.84. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder.
The chemical name for acetaminophen is N-acetyl--aminophenol. Its structural formula is:
The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
Tramadol hydrochloride and acetaminophen tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen and are orange in color. Tramadol hydrochloride and acetaminophen tablets are intended for oral administration. Inactive ingredients in the tablet are crospovidone, magnesium stearate, microcrystalline cellulose, OPADRYII Orange, povidone, pregelatinized starch, purified water, and stearic acid. OPADRYII Orange contains: FD&C red #40; FD&C yellow #6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose; polyethylene glycol; titanium dioxide; triacetate; and triacetin.
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How should I use Tramadol Hydrochloride and Acetaminophen?
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, are indicated for the short-term (five days or less) management of acute pain.
For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.
What interacts with Tramadol Hydrochloride and Acetaminophen?
Tramadol hydrochloride and acetaminophen tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. Tramadol hydrochloride and acetaminophen tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride and acetaminophen tablets may worsen central nervous system and respiratory depression in these patients.
What are the warnings of Tramadol Hydrochloride and Acetaminophen?
Seizure Risk
- Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics),
- Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
- Other opioids.
- MAO inhibitors (see also WARNINGS - Use with MAO Inhibitors),
- Neuroleptics, or
- Other drugs that reduce the seizure threshold.
Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of tramadol increases the seizure risk in patients taking:
Administration of tramadol may enhance the seizure risk in patients taking:
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizure.
Anaphylactoid Reactions
Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride and acetaminophen tablets (see ).
Respiratory Depression
Administer tramadol hydrochloride and acetaminophen tablets cautiously in patients at risk for respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures (see and).
Interaction With Central Nervous System (CNS) Depressants
Tramadol hydrochloride and acetaminophen tablets should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol increases the risk of CNS and respiratory depression in these patients.
lncreased Intracranial Pressure or Head Trauma
Tramadol hydrochloride and acetaminophen tablets should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated, in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patents if they are receiving tramadol hydrochloride and acetaminophen tablets (see ).
Use In Ambulatory Patients
Tramadol may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.
Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors
Use tramadol hydrochloride and acetaminophen tablets with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration of MAO inhibitors and tramadol. Concomitant use of tramadol with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome.
Use With Alcohol
Tramadol hydrochloride and acetaminophen tablets should not be used concomitantly with alcohol consumption. The use of tramadol hydrochloride and acetaminophen tablets in patients with liver disease is not recommended.
Use With Other Acetaminophen-containing Products
Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, tramadol hydrochloride and acetaminophen tablets should not be used concomitantly with other acetaminophen-containing products.
Withdrawal
Withdrawal symptoms may occur if tramadol hydrochloride and acetaminophen tablets are discontinued abruptly. (See These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol hydrochloride and acetaminophen tablet discontinuation include: panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering tramadol hydrochloride and acetaminophen tablets at the time of discontinuation.
Physical Dependence and Abuse
Tramadol may induce psychic and physical dependence of the morphine-type (µ-opioid). (See .) Tramadol should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence.
Risk of Overdosage
Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment. (See )
Serious potential consequences of overdosage with acetaminophen are hepatic (centrilobular) necrosis, leading to hepatic failure and death. Emergency help should be sought immediately and treatment initiated immediately if overdose is suspected, even if symptoms are not apparent.
What are the precautions of Tramadol Hydrochloride and Acetaminophen?
General
The recommended dose of tramadol hydrochloride and acetaminophen tablets should not be exceeded.
Do not co-administer tramadol hydrochloride and acetaminophen tablets with other tramadol or acetaminophen-containing products. (See and)
Pediatric Use
The safety and effectiveness of tramadol hydrochloride and acetaminophen tablets has not been studied in the pediatric population.
Geriatric Use
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.
Acute Abdominal Conditions
The administration of tramadol hydrochloride and acetaminophen tablets may complicate the clinical assessment of patients with acute abdominal conditions.
Use In Renal Disease
Tramadol hydrochloride and acetaminophen tablets have not been studied in patients with impaired renal function. Experience with tramadol suggests that impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride and acetaminophen tablets be increased not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease
Tramadol hydrochloride and acetaminophen tablets have not been studied in patients with impaired hepatic function. The use of tramadol hydrochloride and acetaminophen tablets in patients with hepatic impairment is not recommended (see ).
Information for Patients
Drug Interactions
In vitro
Use With Carbamazepine
Patients taking may have a significantly reduced analgesic effect of tramadol. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of tramadol hydrochloride and acetaminophen tablets and carbamazepine is not recommended.
Use With Quinidine
Tramadol is metabolized to M1 by CYP2D6. is a selective inhibitor of that isoenzyme; so that concomitant administration of quinidine and tramadol results in increased concentrations of tramadol and reduced concentrations of M1. The clinical consequences of these findings are unknown. drug interaction studies in human liver microsomes indicate that tramadol has no effect on quinidine metabolism.
Use With Inhibitors of CYP2D6
In vitro
Use With Cimetidine
Concomitant administration of tramadol hydrochloride and acetaminophen tablets and has not been studied. Concomitant administration of tramadol and cimetidine does not result in clinically significant changes in tramadol pharmacokinetics. Therefore, no alteration of the tramadol hydrochloride and acetaminophen tablets dosage regimen is recommended.
Use With MAO Inhibitors
Interactions with , due to interference with detoxification mechanisms, have been reported for some centrally acting drugs (see ).
Use With Digoxin
Post-marketing surveillance of tramadol has revealed rare reports of toxicity.
Use With Warfarin Like Compounds
Post-marketing surveillance of both tramadol and acetaminophen individual products have revealed rare alterations of warfarin effect, including elevation of prothrombin times.
While such changes have been generally of limited clinical significance for the individual products, periodic evaluation of prothrombin time should be performed when tramadol hydrochloride and acetaminophen tablets and warfarin-like compounds are administered concurrently.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no animal or laboratory studies on the combination product (tramadol and acetaminophen) to evaluate carcinogenesis, mutagenesis, or impairment of fertility.
A slight but statistically significant increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m or 0.5 times the maximum daily human tramadol dosage of 185 mg/m) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m, or 1 time the maximum daily human tramadol dosage).
Tramadol was not mutagenic in the following assays: Ames microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans.
No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg (350 mg/m) in male rats and 75 mg/kg (450 mg/m) in female rats. These dosages are 1.6 and 2.4 times the maximum daily human tramadol dosage of 185 mg/m.
Pregnancy
Teratogenic Effects: Pregnancy Category C
No drug-related teratogenic effects were observed in the progeny of rats treated orally with tramadol and acetaminophen. The tramadol/acetaminophen combination product was shown to be embryotoxic and fetotoxic in rats at a maternally toxic dose, 50/434 mg/kg tramadol/acetaminophen (300/2604 mg/m or 1.6 times the maximum daily human tramadol/acetaminophen dosage of 185/1591 mg/m), but was not teratogenic at this dose level. Embryo and fetal toxicity consisted of decreased fetal weights and increased supernumerary ribs.
Non-teratogenic effects:
Tramadol alone was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m or 1.6 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m or 2.6 times the maximum daily human tramadol dosage).
There are no adequate and well-controlled studies in pregnant women. Tramadol hydrochloride and acetaminophen tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported with tramadol hydrochloride during post-marketing.
Labor & Delivery
Tramadol hydrochloride and acetaminophen tablets should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. (See ) Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor.
The effect of tramadol hydrochloride and acetaminophen tablets, if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers
Tramadol hydrochloride and acetaminophen tablets are not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post-dose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1.
What are the side effects of Tramadol Hydrochloride and Acetaminophen?
Table 2 reports the incidence rate of treatment-emergent adverse events over five days of tramadol hydrochloride and acetaminophen tablet use in clinical trials (subjects took an average of at least 6 tablets per day).
Incidence at least 1%, causal relationship at least possible or greater:
Body as a Whole
Central and Peripheral Nervous System
Gastrointestinal System
Psychiatric Disorders
Skin and Appendages
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 tramadol hydrochloride and acetaminophen tablets clinical trials.
Body as a Whole
Cardiovascular Disorders
Central and Peripheral Nervous System
Gastrointestinal System
Hearing and Vestibular Disorders
Heart Rate and Rhythm Disorders
Liver and BiIiary System
Metabolic and Nutritional Disorders
Psychiatric Disorders
Red Blood Cell Disorders
Respiratory System
Urinary System
Vision Disorders
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.
| * Number of males = 62 | |
| Body System | Tramadol Hydrochloride and Acetaminophen % |
| Gastrointestinal System Disorders | |
| Constipation | 6 |
| Diarrhea | 3 |
| Nausea | 3 |
| Dry Mouth | 2 |
| Psychiatric Disorders | |
| Somnolence | 6 |
| Anorexia | 3 |
| Insomnia | 2 |
| Central & Peripheral Nervous System | |
| Dizziness | 3 |
| Skin and Appendages | |
| Sweating Increased | 4 |
| Pruritus | 2 |
| Reproductive Disorders, Male[1] | |
| Prostatic Disorder | 2 |
What should I look out for while using Tramadol Hydrochloride and Acetaminophen?
Tramadol hydrochloride and acetaminophen tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. Tramadol hydrochloride and acetaminophen tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride and acetaminophen tablets may worsen central nervous system and respiratory depression in these patients.
What might happen if I take too much Tramadol Hydrochloride and Acetaminophen?
Tramadol hydrochloride and acetaminophen tablet is a combination product. The clinical presentation of overdose may include the signs and symptoms of tramadol toxicity, acetaminophen toxicity or both. The initial symptoms of tramadol overdosage may include respiratory depression and or seizures. The initial symptoms seen within the first 24 hours following an acetaminophen overdose are: anorexia, nausea, vomiting, malaise, pallor and diaphoresis.
How should I store and handle Tramadol Hydrochloride and Acetaminophen?
Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.Tramadol hydrochloride and acetaminophen tablets, 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed "083" on one side and "KALI" on the other .They are supplied by as follows:Dispense in a tight container. Store at 25C (77F); excursions permitted to 15º to 30C (59º to 86F).Manufactured by:PAR PHARMACEUTICAL COMPANIES, INC.Spring Valley, NY 10977This Product was Repackaged By Sandhills Repackaging For:Keltman Pharmaceuticals Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The following information is based on studies of tramadol alone or acetaminophen alone, except where otherwise noted:
Non-Clinical Toxicology
Tramadol hydrochloride and acetaminophen tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. Tramadol hydrochloride and acetaminophen tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride and acetaminophen tablets may worsen central nervous system and respiratory depression in these patients.In vitro
The recommended dose of tramadol hydrochloride and acetaminophen tablets should not be exceeded.
Do not co-administer tramadol hydrochloride and acetaminophen tablets with other tramadol or acetaminophen-containing products. (See and)
Table 2 reports the incidence rate of treatment-emergent adverse events over five days of tramadol hydrochloride and acetaminophen tablet use in clinical trials (subjects took an average of at least 6 tablets per day).
Incidence at least 1%, causal relationship at least possible or greater:
Body as a Whole
Central and Peripheral Nervous System
Gastrointestinal System
Psychiatric Disorders
Skin and Appendages
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 tramadol hydrochloride and acetaminophen tablets clinical trials.
Body as a Whole
Cardiovascular Disorders
Central and Peripheral Nervous System
Gastrointestinal System
Hearing and Vestibular Disorders
Heart Rate and Rhythm Disorders
Liver and BiIiary System
Metabolic and Nutritional Disorders
Psychiatric Disorders
Red Blood Cell Disorders
Respiratory System
Urinary System
Vision Disorders
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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