What are the possible side effects of Primsulfon?
Get emergency medical help if you have any of these signs of an allergic reaction to Primsulfon: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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diarrhea that is watery or bloody;
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pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
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sudden weakness or ill feeling, fever, chills, sore throat, new or worsening cough;
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cold or flu symptoms, swollen gums, painful mouth sores, pain when swallowing, skin sores;
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low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
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liver problems--upper stomach pain, tired feeling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Primsulfon side effects may include:
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nausea, vomiting, loss of appetite; or
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mild itching or rash.
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.
Side effects of Primsulfon in details
The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA, OTHER BLOOD DYSCRASIAS, AND HYPERSENSITIVITY OF THE RESPIRATORY TRACT.
Hematologic
Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.
Allergic
Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch- Schönlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria, and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.
Gastrointestinal
Hepatitis, including cholestatic jaundice and hepatic necrosis, elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.
Genitourinary
Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria, and nephrotoxicity in association with cyclosporine.
Metabolic
Hyperkalemia, hyponatremia.
Neurologic
Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.
Psychiatric
Hallucinations, depression, apathy, nervousness.
Endocrine
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.
Musculoskeletal
Arthralgia and myalgia. Cases of rhabdomyolysis have been reported with Primsulfon, mainly in AIDS patients.
Respiratory System
Cough, shortness of breath, and pulmonary infiltrates.
Miscellaneous
Weakness, fatigue, insomnia.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of trimethoprimsulfamethoxazole. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- Thrombotic thrombocytopenia purpura
- Idiopathic thrombocytopenic purpura
- QT prolongation resulting in ventricular tachycardia and torsade de pointes
What is the most important information I should know about Primsulfon?
- Primsulfon may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Primsulfon. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Mild diarrhea is common with antibiotic use. However, a more serious and sometimes fatal form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
- Be sure to use Primsulfon for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Primsulfon only works against bacteria; it does not treat viral infections (eg, the common cold).
- Long-term or repeated use of Primsulfon may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Severe and sometimes fatal liver problems have happened in patients taking Primsulfon. Tell your doctor right away if you develop symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea or vomiting, loss of appetite, or stomach pain; unusual tiredness; yellowing of skin or eyes).
- Serious and sometimes fatal blood problems may happen. Contact your doctor immediately if you develop fever, chills, or sore throat; joint pain; pale skin; unusual bruising or bleeding; or unusual tiredness or weakness.
- Primsulfon may cause serious lung problems. Tell your doctor right away if you develop a cough, shortness of breath, or chest pain.
- Patients taking Primsulfon to treat a certain type of pneumonia should avoid taking leucovorin. It may decrease Primsulfon's effectiveness. Talk with your doctor if you are taking leucovorin.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Primsulfon. Talk with your doctor before you receive any vaccine.
- Diabetes patients - Primsulfon may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Primsulfon may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Primsulfon.
- Lab tests, including complete blood cell counts, blood potassium levels, and kidney function, may be performed while you use Primsulfon. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Primsulfon with caution in the ELDERLY; they may be more sensitive to its effects, especially severe skin reactions, bone marrow problems, or high blood potassium levels.
- Primsulfon should not be used in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Primsulfon may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Primsulfon while you are pregnant. Primsulfon is found in breast milk. If you are or will be breast-feeding while you use Primsulfon, check with your doctor. Discuss any possible risks to your baby.
Primsulfon contraindications
Primsulfon is contraindicated in patients with a known hypersensitivity to Trimethoprim (Primsulfon), USP or sulfonamides, in patients with a history of drug-induced immune thrombocytopenia with use of Trimethoprim (Primsulfon), USP and/or sulfonamides, and in patients with documented megaloblastic anemia due to folate deficiency.
Primsulfon is contraindicated in pediatric patients less than 2 months of age. Primsulfon is also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored.
References
- DailyMed. "SULFAMETHOXAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "B-Lock: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Primsulfon are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Primsulfon. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology