Consists of Phenazopyridine, Trimethoprim
What are the possible side effects of Phenazopyridine?
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 Phenazopyridine and call your doctor at once if you have any of these serious side effects:
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pale skin, fever, confusion or weakness;
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jaundice (yellowing of your skin or eyes);
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urinating less than usual or not at all;
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drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
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swelling, weight gain, feeling short of breath; or
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blue or purple coloring in your skin.
Less serious side effects of Phenazopyridine may include:
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headache;
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dizziness;
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stomach pain, upset stomach; or
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skin itching.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Phenazopyridine in details
Applies to phenazopyridine: oral kit, oral tablet
In addition to its needed effects, some unwanted effects may be caused by phenazopyridine (the active ingredient contained in Phenazopyridine). In the event that any of these side effects do occur, they may require medical attention.
Severity: Moderate
If any of the following side effects occur while taking phenazopyridine, check with your doctor or nurse as soon as possible:
Rare
- Blue or blue-purple color of skin
- fever and confusion
- shortness of breath, tightness in chest, wheezing, or troubled breathing
- skin rash
- sudden decrease in the amount of urine
- swelling of face, fingers, feet, and/or lower legs
- unusual tiredness or weakness
- weight gain
- yellow eyes or skin
Minor Side Effects
Some of the side effects that can occur with phenazopyridine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common or rare:
- Dizziness
- headache
- indigestion
- itching of the skin
- stomach cramps or pain
What is the most important information I should know about Phenazopyridine?
- Do NOT take more than the recommended dose or use for longer than 2 days without checking with your doctor.
- Do not use phenazopyridine for future urinary tract problems without first checking with your doctor.
- Phenazopyridine may change the color of your urine to orange or red. It may also stain fabric. This is normal and not a cause for concern.
- Do not wear soft contact lenses while taking phenazopyridine; permanent staining of the lenses may occur.
- Phenazopyridine may interfere with certain lab tests including urinalysis. Be sure your doctor and lab personnel know you are taking phenazopyridine.
- Use phenazopyridine with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using phenazopyridine while you are pregnant. It is not known if phenazopyridine is found in breast milk. If you are or will be breast-feeding while you use phenazopyridine, check with your doctor. Discuss any possible risks to your baby.
Phenazopyridine contraindications
Do not take this medication if you are allergic to phenazopyridine, or if you have kidney disease.
Phenazopyridine will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection.
To avoid stomach upset, take phenazopyridine with food.
Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.
Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.
Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.
Stop taking this medication and call your doctor at once if you have pale skin, fever, confusion, yellowing of your skin or eyes, increased thirst, swelling, or if you urinate less than usual or not at all.
What are the possible side effects of Trimethoprim?
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Nausea; skin sensitivity to sunlight; stomach upset; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistered, peeling, red, or swollen skin; bloody or black, tarry stools; chest pain; chills, fever, or sore throat; decreased urination; joint or muscle pain; irregular heartbeat; painful or stiff neck; purple patches under the skin; seizures; severe diarrhea; shortness of breath; stomach cramps/pain; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin; vaginal irritation or discharge; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Side effects of Trimethoprim in details
To report SUSPECTED ADVERSE REACTIONS, contact Key Therapeutics, LLC at 1-888-981-8337, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse Events Reported During Pediatric Clinical Trials With Trimethoprim
The following table lists those drug-related adverse events reported most frequently during the clinical trials in pediatric patients aged 6 months to 12 years. Most of these events were determined to be mild. The incidence of drug related adverse events was significantly lower for Trimethoprim, which was most apparent for those events related to skin/appendages as a body system.
| Drug-related Adverse Event | Percent of Pediatric Patients | |
|---|---|---|
| Trimethoprim (N=310) | SMX + TMP* (N=197) | |
| ||
| Body as a whole | ||
| abdominal pain | <1 | 2.5 |
| Digestive system | ||
| diarrhea | 4.2 | 4.6 |
| vomiting | 1.6 | 1.5 |
| Skin/Appendages | ||
| rash | 1.3 | 6.1 |
An increase in lymphocytes and eosinophils was noted in some pediatric patients following treatment with Trimethoprim or sulfamethoxazole + trimethoprim oral suspension.
Adverse Reactions Reported For Trimethoprim
In addition to the adverse events listed above which have been observed in pediatric patients receiving Trimethoprim, the following adverse reactions and altered laboratory tests have been previously reported for trimethoprim and therefore, may occur with Trimethoprim therapy:
Dermatologic reactions: pruritus and exfoliative dermatitis. At the recommended adult dosage regimens of 100 mg b.i.d., or 200 mg q.d., each for 10 days, the incidence of rash is 2.9% to 6.7%. In clinical studies which employed high doses of trimethoprim in adults, an elevated incidence of rash was noted. These rashes were maculopapular, morbilliform, pruritic and generally mild to moderate, appearing 7 to 14 days after the initiation of therapy.
Gastrointestinal reactions: Epigastric distress, nausea, and glossitis.
Hematologic reactions: Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia and methemoglobinemia.
Metabolic reactions: Hyperkalemia, hyponatremia.
Miscellaneous reactions: Fever, elevation of serum transaminase and bilirubin, and increases in BUN and serum creatinine levels.
What is the most important information I should know about Trimethoprim?
- Trimethoprim may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Trimethoprim. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- 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 Trimethoprim 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.
- Trimethoprim only works against bacteria; it does not treat viral infections (eg, the common cold).
- Long-term or repeated use of Trimethoprim 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.
- Trimethoprim may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Trimethoprim.
- Lab tests, including complete blood cell counts, may be performed while you use Trimethoprim. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Trimethoprim with caution in ELDERLY patients; they may be more sensitive to the effects of Trimethoprim.
- Trimethoprim should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
- Use Trimethoprim with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Trimethoprim while you are pregnant. Trimethoprim is found in breast milk. If you are or will be breast-feeding while you use Trimethoprim, check with your doctor. Discuss any possible risks to your baby.
Trimethoprim contraindications
Trimethoprim (trimethoprim (trimethoprim tablet) tablet) tablets are contraindicated in individuals hypersensitive to trimethoprim (trimethoprim (trimethoprim tablet) tablet) and in those with documented megaloblastic anemia due to folate deficiency.
References
- 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).
- DTP/NCI. "phenazopyridine: 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 Phenazopyridine/Trimethoprim 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 Phenazopyridine/Trimethoprim. 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
