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Sulfamethoxazole Side Effects

Common Sulfamethoxazole Side Effects


The most commonly reported Sulfamethoxazole side effects (click to view or check a box to report):

Renal Failure Acute (166)
Rash (145)
Hyperkalaemia (112)
Nausea (103)
Pyrexia (96)
Pruritus (77)
Vomiting (67)
Urticaria (64)
Headache (61)
Asthenia (60)
Stevens-johnson Syndrome (58)
Fatigue (53)
Pain (52)
Dyspnoea (51)
Chills (50)
Diarrhoea (44)
Blood Creatinine Increased (43)
Angioedema (42)
Dizziness (41)
Arthralgia (38)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Sulfamethoxazole Side Effects Reported to FDA

The following Sulfamethoxazole reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Sulfamethoxazole on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Renal Failure, Hyperkalaemia
This is a report of a 75-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time: Jul 01, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Renal Failure
  • Hyperkalaemia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in renal failure side effect. The patient was hospitalized.

Stevens-johnson Syndrome, Toxic Epidermal Necrolysis, Rash
This report suggests a potential Sulfamethoxazole/trimethoprim 800 Mg/160 Stevens-johnson Syndrome, Toxic Epidermal Necrolysis, Rash side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: infection and used Sulfamethoxazole/trimethoprim 800 Mg/160 (dosage: 1 Bid Oral) starting NS. Soon after starting Sulfamethoxazole/trimethoprim 800 Mg/160 the patient began experiencing various side effects, including:
  • Stevens-johnson Syndrome
  • Toxic Epidermal Necrolysis
  • Rash
Drugs used concurrently: NA. Although Sulfamethoxazole/trimethoprim 800 Mg/160 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as stevens-johnson syndrome, may still occur.

Stevens-johnson Syndrome, Wound
This Stevens-johnson Syndrome, Wound problem was reported by a health professional from US. A 34-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cellulitis. On Mar 02, 2014 this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects:
  • Stevens-johnson Syndrome
  • Wound
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as stevens-johnson syndrome, may become evident only after a product is in use by the general population.

Hyponatraemia, Hypokalaemia
This is a report of a 57-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: pneumocystis jirovecii pneumonia and was treated with Sulfamethoxazole-trimethoprim, Ds (dosage: NA) starting NS. Concurrently used drugs:
  • Acetaminophen
  • Azithromycin
  • Budesonide
  • Dextrose
  • Emtricitabine/tenofovir
  • Etravirine
  • Heparin
  • Ipratropium/albuterol
Soon after that, the consumer experienced the following side effects:
  • Hyponatraemia
  • Hypokalaemia
The patient was hospitalized. This opens a possibility that Sulfamethoxazole-trimethoprim, Ds treatment could cause the above reactions, including hyponatraemia, and some male subjects may be more susceptible.


Pharyngitis, Dysphagia, Odynophagia, Dysphonia, Oral Candidiasis, Agranulocytosis
A 68-year-old male patient (weight: NA) from US with the following symptoms/conditions: furuncle started Sulfamethoxazole And Trimethorpim treatment (dosage: NA) on NS. Soon after starting Sulfamethoxazole And Trimethorpim treatment, the subject experienced various side effects, including:
  • Pharyngitis
  • Dysphagia
  • Odynophagia
  • Dysphonia
  • Oral Candidiasis
  • Agranulocytosis
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Sulfamethoxazole And Trimethorpim.

Nausea, Vomiting, Hyperkalaemia, Bradycardia, Dialysis
A 66-year-old male patient from US (weight: NA) experienced symptoms, such as: urinary tract infection,hypertension and was treated with Sulfamethoxazole/trimethoprim(dosage: NA). The treatment was initiated on May 12, 2010. After that a consumer reported the following side effect(s):
  • Nausea
  • Vomiting
  • Hyperkalaemia
  • Bradycardia
  • Dialysis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Sulfamethoxazole/trimethoprim efficacy:
  • Spironolactone
The patient was hospitalized.

Oral Mucosal Discolouration, Paraesthesia Oral, Lip Swelling
In this report, Sulfamethoxazole/trimethoprim Tablets was administered for the following condition: NA.A 35-year-old female consumer from US (weight: NA) started Sulfamethoxazole/trimethoprim Tablets treatment (dosage: 800 Mg/160 Mg) on 201303.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Oral Mucosal Discolouration
  • Paraesthesia Oral
  • Lip Swelling
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Sulfamethoxazole/trimethoprim Tablets treatment could be related to the listed above side effect(s).

Palpitations, Dizziness, Dyspnoea, Penile Blister, Burns Second Degree
This is a report of the following Sulfamethoxazole/trimethoprim 800/160 side effect(s):
  • Palpitations
  • Dizziness
  • Dyspnoea
  • Penile Blister
  • Burns Second Degree
A 46-year-old male patient from US (weight: NA) presented with the following condition: sinusitis and received a treatment with Sulfamethoxazole/trimethoprim 800/160 (dosage: One Table Twice Daily) starting: Feb 13, 2014.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Sulfamethoxazole/trimethoprim 800/160 treatment could be associated with the listed above side effect(s).

Candida Infection, Agranulocytosis
This Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg report was submitted by a 68-year-old male consumer from US (weight: NA). The patient was diagnosed with: antibiotic prophylaxis and Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Candida Infection
  • Agranulocytosis
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Renal Failure Acute, Hyperkalaemia
This is a report of a possible correlation between Sulfamethoxazole/trimethoprim use and the following symptoms/side effect(s):
  • Renal Failure Acute
  • Hyperkalaemia
which could contribute to an assessment of Sulfamethoxazole/trimethoprim risk profile.A 94-year-old male consumer from US (weight: NA) was suffering from NA and was treated with Sulfamethoxazole/trimethoprim (dosage: NA) starting May 15, 2001.Other concurrent medications:
  • Lisinopril
The patient was hospitalized.

Hyperkalaemia
A 71-year-old male patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Sulfamethoxazole/trimethoprim (dosage: NA) experienced the following side effect(s):
  • Hyperkalaemia
The treatment was started on Mar 11, 2013. Sulfamethoxazole/trimethoprim was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Sulfamethoxazole/trimethoprim consumers.

Hyperkalaemia, Blood Pressure Decreased, Heart Rate Decreased, Nodal Rhythm, Bundle Branch Block Left, Electrocardiogram Qrs Complex Prolonged, Electrocardiogram T Wave Peaked, Metabolic Acidosis, Haemodialysis
In this report, a 85-year-old female patient from US (weight: NA) was affected by a possible Sulfamethoxazole And Trimethoprim side effect.The patient was diagnosed with urinary tract infection. After a treatment with Sulfamethoxazole And Trimethoprim (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Hyperkalaemia
  • Blood Pressure Decreased
  • Heart Rate Decreased
  • Nodal Rhythm
  • Bundle Branch Block Left
  • Electrocardiogram Qrs Complex Prolonged
  • Electrocardiogram T Wave Peaked
  • Metabolic Acidosis
  • Haemodialysis
The following simultaneously used drugs could have led to this reaction:
  • Spironolactone
  • Valsartan
  • Sotalol
The findings here stress that side effects should be taken into consideration when evaluating a Sulfamethoxazole And Trimethoprim treatment.

Polyarthritis
This is a report of a 63-year-old male patient from AU (weight: NA), who used Sulfamethoxazole/trimethoprim (dosage: NA) for a treatment of antifungal prophylaxis,immunosuppression. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Polyarthritis
The following drugs could possibly have interacted with the Sulfamethoxazole/trimethoprim treatment
  • Basiliximab (Pre-operatively And Again On Day 4.)
  • Mycophenolic Acid (Commenced Post-operatively)
  • Prednisolone (Commenced Post-operatively)
  • Tacrolimus (Commenced Post-operatively)
  • Methylprednisolone (Pre-operatively)
The patient was hospitalized.Taken together, these observations suggest that a Sulfamethoxazole/trimethoprim treatment could be related to side effect(s), such as Polyarthritis.

Renal Failure Acute, Hyponatraemia
This renal failure acute side effect was reported by a pharmacist from US. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: pneumocystis jirovecii pneumonia. The patient was prescribed Sulfamethoxazole/trimethoprim (dosage: NA), which was started on Aug 09, 2013. Concurrently used drugs: NA. When starting to take Sulfamethoxazole/trimethoprim the consumer reported the following symptoms:
  • Renal Failure Acute
  • Hyponatraemia
The patient was hospitalized. These side effects may potentially be related to Sulfamethoxazole/trimethoprim.

Renal Failure Acute, Rash Erythematous, Rhabdomyolysis, Diarrhoea, Dialysis
This is a Sulfamethoxazole/trimethoprim side effect report of a 67-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: urinary tract infection, who was treated with Sulfamethoxazole/trimethoprim (dosage:NA, start time: Jul 04, 2012), combined with: NA., and developed a serious reaction and a renal failure acute side effect. The patient presented with:
  • Renal Failure Acute
  • Rash Erythematous
  • Rhabdomyolysis
  • Diarrhoea
  • Dialysis
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients suffering from urinary tract infection, resulting in renal failure acute.

Renal Failure Acute, Hyperkalaemia
This report suggests a potential Sulfamethoxazole/trimethoprim renal failure acute side effect(s) that can have serious consequences. A 55-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): infection,hypertension and used Sulfamethoxazole/trimethoprim (dosage: 1 Tab, Bid, Po) starting Oct 04, 2002. Soon after starting Sulfamethoxazole/trimethoprim the patient began experiencing various side effects, including:
  • Renal Failure Acute
  • Hyperkalaemia
Drugs used concurrently:
  • Lisinopril
The patient was hospitalized. Although Sulfamethoxazole/trimethoprim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as renal failure acute, may still occur.

Fatigue, Asthenia, Lethargy, Renal Failure Acute
This fatigue problem was reported by a pharmacist from US. A 69-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): cellulitis,hypertension.On Jan 18, 2006 a consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: 2 Tab, Bid, Po). The following drugs/medications were being taken at the same time:
  • Losartan
When commencing Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms /side effects:
  • Fatigue
  • Asthenia
  • Lethargy
  • Renal Failure Acute
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as fatigue, may become evident only after a product is in use by the general population.

Dehydration, Hypotension, Eosinophilia, Renal Failure Acute
This is a Sulfamethoxazole\trimethoprim side effect report of a 58-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: urinary tract infection and was treated with Sulfamethoxazole\trimethoprim (dosage: NA) starting Oct 18, 2010. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Dehydration
  • Hypotension
  • Eosinophilia
  • Renal Failure Acute
The patient was hospitalized. This opens a possibility that Sulfamethoxazole\trimethoprim could cause dehydration and that some female patients may be more susceptible.

Asthenia, Upper Respiratory Tract Infection, Cough, Respiratory Tract Congestion, Nephropathy Toxic, Renal Failure Acute
A 58-year-old male patient (weight: NA) from US with the following symptoms: infection started Sulfamethoxazole/trimethoprim treatment (dosage: NA) on Feb 20, 2013. Soon after starting Sulfamethoxazole/trimethoprim treatment, the consumer experienced several side effects, including:
  • Asthenia
  • Upper Respiratory Tract Infection
  • Cough
  • Respiratory Tract Congestion
  • Nephropathy Toxic
  • Renal Failure Acute
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Sulfamethoxazole/trimethoprim side effects, such as asthenia.

Diarrhoea, Panic Attack, Anxiety
This diarrhoea side effect was reported by a pharmacist from US. A 41-year-old female patient (weight:NA) experienced the following symptoms/conditions: infection.The patient was prescribed Sulfamethoxazole/trimethoprim (dosage: NA), which was started on Jan 24, 2014. Concurrently used drugs: NA..When starting to take Sulfamethoxazole/trimethoprim the consumer reported symptoms, such as:
  • Diarrhoea
  • Panic Attack
  • Anxiety
These side effects may potentially be related to Sulfamethoxazole/trimethoprim. The patient was hospitalized.

Hypotension, Diarrhoea, Asthenia, Fatigue, Dizziness, Renal Failure Acute, Melaena
This is a report of a 67-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time: Oct 13, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Hypotension
  • Diarrhoea
  • Asthenia
  • Fatigue
  • Dizziness
  • Renal Failure Acute
  • Melaena
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in hypotension side effect.

Nerve Injury
This report suggests a potential Sulfamethoxazole/tmp Ds Nerve Injury side effect(s) that can have serious consequences. A 25-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: staphylococcal infection and used Sulfamethoxazole/tmp Ds (dosage: 20, Twice Daily, Mouth) starting May 18, 2013. Soon after starting Sulfamethoxazole/tmp Ds the patient began experiencing various side effects, including:
  • Nerve Injury
Drugs used concurrently:
  • Thyroid
  • Adderall
Although Sulfamethoxazole/tmp Ds demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as nerve injury, may still occur.

Pseudomembranous Colitis, Megacolon
This Pseudomembranous Colitis, Megacolon problem was reported by a physician from US. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis,leukaemia cutis. On NS this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: Unk). The following drugs were being taken at the same time:
  • Carbenicillin (Unk)
  • Ticarcillin (Unk)
  • Allopurinol (Unk)
  • Cytosine Arabinoside ((100 Mg/m2 ) On Days 1 Through 7)
  • Doxorubicin (Doxorubicin (35 Mg/m2 ) On Days 1 Through 3)
  • Gentamicin (Unk)
  • Cephalothin (Unk)
When commencing Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects:
  • Pseudomembranous Colitis
  • Megacolon
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pseudomembranous colitis, may become evident only after a product is in use by the general population.

Meningitis
This is a report of a 77-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: urinary tract infection and was treated with Sulfamethoxazole/tmp Ds (dosage: 1 Tablet, Twice A Day, By Mouth) starting NS. Concurrently used drugs:
  • Donepezil
  • Risperidone
  • Lorazepam
  • Sertraline
  • Metoprolol Tartrate
  • Amlodipine Besylate
  • Sucralfate
  • Viactiv Calcium Plus D
Soon after that, the consumer experienced the following side effects:
  • Meningitis
The patient was hospitalized and became disabled. This opens a possibility that Sulfamethoxazole/tmp Ds treatment could cause the above reactions, including meningitis, and some female subjects may be more susceptible.

Neutropenia, Rash, Pyrexia
A 73-year-old male patient (weight: NA) from US with the following symptoms/conditions: prostatitis started Sulfamethoxazole/trimethoprim treatment (dosage: NA) on Sep 09, 2013. Soon after starting Sulfamethoxazole/trimethoprim treatment, the subject experienced various side effects, including:
  • Neutropenia
  • Rash
  • Pyrexia
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Sulfamethoxazole/trimethoprim.

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Top 10 Sulfamethoxazole Side Effects for Women

Women Side EffectsReports
Rash 50
Pyrexia 46
Pruritus 42
Headache 40
Nausea 40
Pain 40
Vomiting 29
Fatigue 28
Arthralgia 27
Dyspnoea 27

Top 10 Sulfamethoxazole Side Effects for Men

Men Side EffectsReports
Renal Failure Acute 157
Hyperkalaemia 107
Rash 94
Nausea 63
Pyrexia 48
Asthenia 45
Urticaria 40
Vomiting 38
Stevens-johnson Syndrome 37
Blood Creatinine Increased 35

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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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    Sulfamethoxazole Safety Alerts, Active Ingredients, Usage Information

    NDC0093-0088
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameSulfamethoxazole and Trimethoprim
    NameSulfamethoxazole and Trimethoprim
    Dosage FormTABLET
    RouteORAL
    On market since19900930
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)SULFAMETHOXAZOLE; TRIMETHOPRIM
    Strength(s)400; 80
    Unit(s)mg/1; mg/1
    Pharma ClassSulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [M

    More About Sulfamethoxazole

    Side Effects reported to FDA: 1252

    Sulfamethoxazole safety alerts: No

    Reported deaths: 31

    Reported hospitalizations: 496

    Latest Sulfamethoxazole clinical trials