Medically reviewed by Drugs.com. Last updated on Aug 14, 2020.
(a mee noe sal i SIL ik AS id)
- 4-Aminosalicylic Acid
- Aminosalicylate Calcium
- Aminosalicylate Sodium
- Calcium Paraaminosalicylate
- Para-Aminosalicylate Sodium
- Para-Aminosalicylic Acid
- Sodium PAS
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Packet, Extended-Release Granules, Oral:
Paser: 4 g (30 ea)
Brand Names: U.S.
- Antitubercular Agent
Aminosalicylic acid (PAS) is a highly-specific bacteriostatic agent active against M. tuberculosis. Structurally related to para-aminobenzoic acid (PABA) and its mechanism of action is thought to be similar to the sulfonamides, a competitive antagonism with PABA; disrupts plate biosynthesis in sensitive organisms.
Hepatic (>50%) via acetylation
Urine (>80% as unchanged drug and metabolites)
Time to Peak
Serum: 6 hours
Reduced with renal impairment
50% to 60%
Special Populations: Renal Function Impairment
Drug and its acetyl metabolite may accumulate.
Use: Labeled Indications
Tuberculosis: Treatment of tuberculosis in combination with other antitubercular agents.
Hypersensitivity to aminosalicylic acid or any component of the formulation; severe renal impairment
Tuberculosis, drug resistant (alternative agent): Note: Expert consultation for optimal regimen and duration of treatment is advised.
Oral: 4 g two to three times daily as part of an appropriate combination regimen (ATS/CDC/ERS/IDSA [Nahid 2019]).
Refer to adult dosing.
Tuberculosis (second-line agent):
Children ≤40 kg and Adolescents <15 years: Oral: 200 to 300 mg/kg/day (usually 100 mg/kg/dose 2 to 3 times daily). Note: Use in combination with other antituberculous agents (Nahid 2016).
Children >40 kg and Adolescents ≥15 years: Refer to adult dosing.
May be administered with food. Do not use granules if packet is swollen or if granules are discolored (ie, brown or purple). Granules may be sprinkled on applesauce or yogurt (do not chew) or suspended in tomato or orange juice.
Prior to dispensing, store granules below 15°C (59°F). Once dispensed store in refrigerator or freezer; packets may be stored at room temperature for short periods of time. Do not use if packet is swollen or if granules are dark brown or purple.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy
Agents with Blood Glucose Lowering Effects: Salicylates may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy
Ajmaline: Salicylates may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Monitor therapy
Ammonium Chloride: May increase the serum concentration of Salicylates. Monitor therapy
Angiotensin-Converting Enzyme Inhibitors: Salicylates may enhance the nephrotoxic effect of Angiotensin-Converting Enzyme Inhibitors. Salicylates may diminish the therapeutic effect of Angiotensin-Converting Enzyme Inhibitors. Monitor therapy
Anticoagulants: Salicylates may enhance the anticoagulant effect of Anticoagulants. Monitor therapy
Benzbromarone: Salicylates may diminish the therapeutic effect of Benzbromarone. Monitor therapy
Carbonic Anhydrase Inhibitors: Salicylates may enhance the adverse/toxic effect of Carbonic Anhydrase Inhibitors. Salicylate toxicity might be enhanced by this same combination. Management: Avoid these combinations when possible.Dichlorphenamide use with high-dose aspirin as contraindicated. If another combination is used, monitor patients closely for adverse effects. Tachypnea, anorexia, lethargy, and coma have been reported. Exceptions: Brinzolamide; Dorzolamide. Consider therapy modification
Corticosteroids (Systemic): Salicylates may enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy
Dexketoprofen: Salicylates may enhance the adverse/toxic effect of Dexketoprofen. Dexketoprofen may diminish the therapeutic effect of Salicylates. Salicylates may decrease the serum concentration of Dexketoprofen. Management: The use of high-dose salicylates (3 g/day or more in adults) together with dexketoprofen is inadvisable. Consider administering dexketoprofen 30-120 min after or at least 8 hrs before cardioprotective doses of aspirin to minimize any possible interaction. Avoid combination
Ginkgo Biloba: May enhance the anticoagulant effect of Salicylates. Management: Consider alternatives to this combination of agents. Monitor for signs and symptoms of bleeding (especially intracranial bleeding) if salicylates are used in combination with ginkgo biloba. Consider therapy modification
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Salicylates. Bleeding may occur. Management: Avoid coadministration of herbs possessing anticoagulant/antiplatelet properties and salicylates. If coadministered, monitor for bleeding. Discontinue anticoagulant/antiplatelet herbs 2 weeks prior to surgical, dental or invasive procedures. Consider therapy modification
Hyaluronidase: Salicylates may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving salicylates (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Influenza Virus Vaccine (Live/Attenuated): May enhance the adverse/toxic effect of Salicylates. Specifically, Reye's syndrome may develop. Avoid combination
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Monitor therapy
Loop Diuretics: Salicylates may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may increase the serum concentration of Salicylates. Monitor therapy
Methotrexate: Salicylates may increase the serum concentration of Methotrexate. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Management: Consider avoiding coadministration of methotrexate and salicylates. If coadministration cannot be avoided, monitor for increased toxic effects of methotrexate. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Consider therapy modification
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Nonselective): May enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Management: Nonselective NSAIDs may reduce aspirin's cardioprotective effects. Administer ibuprofen 30-120 minutes after immediate-release aspirin, 2 to 4 hours after extended-release aspirin, or 8 hours before aspirin. Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the adverse/toxic effect of Salicylates. Specifically, the risk of gastrointestinal (GI) toxicity is increased. Management: Coadministration of salicylates and topical NSAIDs is not recommended. If salicylates and topical NSAIDs are coadministered, ensure the benefits outweigh the risks and monitor for increased NSAID toxicities. Consider therapy modification
Potassium Phosphate: May increase the serum concentration of Salicylates. Monitor therapy
PRALAtrexate: Salicylates may increase the serum concentration of PRALAtrexate. Salicylate doses used for prophylaxis of cardiovascular events are unlikely to be of concern. Management: Consider avoiding concomitant use of salicylates and pralatrexate. If coadministered, monitor for increased pralatrexate adverse effects. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Consider therapy modification
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Monitor therapy
Probenecid: Salicylates may diminish the therapeutic effect of Probenecid. Monitor therapy
Salicylates: May enhance the anticoagulant effect of other Salicylates. Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy
Sulfinpyrazone: Salicylates may decrease the serum concentration of Sulfinpyrazone. Avoid combination
Thrombolytic Agents: Salicylates may enhance the adverse/toxic effect of Thrombolytic Agents. An increased risk of bleeding may occur. Monitor therapy
Valproate Products: Salicylates may increase the serum concentration of Valproate Products. Monitor therapy
Varicella Virus-Containing Vaccines: Salicylates may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. Specifically, the risk for Reye's syndrome may increase. Avoid combination
Vitamin K Antagonists (eg, warfarin): Salicylates may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Avoid as needed use of salicylates in patients taking vitamin K antagonists. Aspirin (80 to 325 mg/day) may be used with warfarin for prevention of cardiovascular events. If coadministering salicylates and vitamin K antagonists, monitor for bledding. Consider therapy modification
Frequency not defined.
Cardiovascular: Pericarditis, vasculitis
Central nervous system: Brain disease
Dermatologic: Skin rash (including exfoliative dermatitis)
Endocrine & metabolic: Goiter (with or without myxedema), hypoglycemia, hypothyroidism
Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting
Hematologic & oncologic: Agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia
Hepatic: Hepatitis, jaundice
Ophthalmic: Optic neuritis
Respiratory: Eosinophilic pneumonitis
Concerns related to adverse effects:
• Salicylate sensitivity: Patients with sensitivity to tartrazine dyes, nasal polyps, and asthma may have an increased risk of salicylate sensitivity.
• Gastric ulcer: Use with caution in patients with gastric ulcer.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Renal impairment: Use with caution in patients with renal impairment; contraindicated in patients with severe renal impairment.
Liver function; thyroid function; CBC; serum electrolytes (AST/CDC/ERS/IDSA [Nahid 2019]).
Pregnancy Risk Factor
Teratogenic effects have been reported in animal reproduction studies. Salicylates have been noted to cross the placenta and enter fetal circulation. Aminosalicylic acid has been used safely during pregnancy; however, it should only be used if there are no alternatives for the treatment of multidrug-resistant tuberculosis (ATS/CDC/IDSA 2003).
What is this drug used for?
• It is used to treat TB (tuberculosis).
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Abdominal pain
• Granule shell in stool
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Low blood sugar like dizziness, headache, fatigue, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes
• Skin irritation
• Shortness of breath
• Excessive weight loss
• Night sweats
• Swollen glands
• Sore throat
• Severe loss of strength and energy
• Vision changes
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about aminosalicylic acid
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Drug class: aminosalicylates
Other brands: Paser