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Sulfameth Side Effects

Common Sulfameth Side Effects


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

Renal Failure Acute (166)
Rash (148)
Hyperkalaemia (113)
Nausea (108)
Pyrexia (101)
Pruritus (79)
Vomiting (70)
Headache (68)
Urticaria (66)
Asthenia (63)
Stevens-johnson Syndrome (59)
Pain (55)
Fatigue (55)
Dyspnoea (52)
Chills (50)
Diarrhoea (44)
Blood Creatinine Increased (43)
Dizziness (42)
Angioedema (42)
Arthralgia (39)

➢ 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.

Sulfameth Side Effects Reported to FDA

The following Sulfameth 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 Sulfameth 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.

Nausea, Asthenia, Hunger, Vomiting, Dry Mouth
In this report, a 31-year-old female patient from US (weight: NA) was affected by a possible Sulfamethoxazol/trimethoprim side effect.The patient was diagnosed with urinary tract infection. After a treatment with Sulfamethoxazol/trimethoprim (dosage: NA, start date: Dec 07, 2013), the patient experienced the following side effect(s):
  • Nausea
  • Asthenia
  • Hunger
  • Vomiting
  • Dry Mouth
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Sulfamethoxazol/trimethoprim treatment.

Hyperkalaemia, Blood Pressure Decreased, Heart Rate Decreased, Nodal Rhythm, Bundle Branch Block Left, Electrocardiogram Qrs Complex Prolonged, Electrocardiogram T Wave Peaked, Metabolic Acidosis, Haemodialysis
This is a report of a 85-year-old female patient from US (weight: NA), who used Sulfamethoxazole And Trimethoprim (dosage: NA) for a treatment of urinary tract infection. After starting a treatment on 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 drugs could possibly have interacted with the Sulfamethoxazole And Trimethoprim treatment
  • Spironolactone
  • Valsartan
  • Sotalol
Taken together, these observations suggest that a Sulfamethoxazole And Trimethoprim treatment could be related to side effect(s), such as Hyperkalaemia, Blood Pressure Decreased, Heart Rate Decreased, Nodal Rhythm, Bundle Branch Block Left, Electrocardiogram Qrs Complex Prolonged, Electrocardiogram T Wave Peaked, Metabolic Acidosis, Haemodialysis.

Polyarthritis
This polyarthritis side effect was reported by a pharmacist from AU. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: antifungal prophylaxis,immunosuppression. The patient was prescribed Sulfamethoxazole/trimethoprim (dosage: NA), which was started on NS. Concurrently used drugs:
  • Basiliximab (Pre-operatively And Again On Day 4.)
  • Mycophenolic Acid (Commenced Post-operatively)
  • Prednisolone (Commenced Post-operatively)
  • Tacrolimus (Commenced Post-operatively)
  • Methylprednisolone (Pre-operatively)
When starting to take Sulfamethoxazole/trimethoprim the consumer reported the following symptoms:
  • Polyarthritis
The patient was hospitalized. These side effects may potentially be related to Sulfamethoxazole/trimethoprim.

Renal Failure Acute, Hyponatraemia
This is a Sulfamethoxazole/trimethoprim side effect report of a 63-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: pneumocystis jirovecii pneumonia, who was treated with Sulfamethoxazole/trimethoprim (dosage:NA, start time: Aug 09, 2013), combined with: NA., and developed a serious reaction and a renal failure acute side effect. The patient presented with:
  • Renal Failure Acute
  • Hyponatraemia
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 pneumocystis jirovecii pneumonia, resulting in renal failure acute.

Renal Failure Acute, Rash Erythematous, Rhabdomyolysis, Diarrhoea, Dialysis
This report suggests a potential Sulfamethoxazole/trimethoprim renal failure acute side effect(s) that can have serious consequences. A 67-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): urinary tract infection and used Sulfamethoxazole/trimethoprim (dosage: NA) starting Jul 04, 2012. Soon after starting Sulfamethoxazole/trimethoprim the patient began experiencing various side effects, including:
  • Renal Failure Acute
  • Rash Erythematous
  • Rhabdomyolysis
  • Diarrhoea
  • Dialysis
Drugs used concurrently:NA. 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.

Renal Failure Acute, Hyperkalaemia
This renal failure acute problem was reported by a pharmacist from US. A 55-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): infection,hypertension.On Oct 04, 2002 a consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: 1 Tab, Bid, Po). The following drugs/medications were being taken at the same time:
  • Lisinopril
When commencing Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms /side effects:
  • Renal Failure Acute
  • Hyperkalaemia
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 renal failure acute, may become evident only after a product is in use by the general population.

Fatigue, Asthenia, Lethargy, Renal Failure Acute
This is a Sulfamethoxazole/trimethoprim side effect report of a 69-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: cellulitis,hypertension and was treated with Sulfamethoxazole/trimethoprim (dosage: 2 Tab, Bid, Po) starting Jan 18, 2006. Concurrently used drugs:
  • Losartan
Soon after that, the consumer experienced the following of symptoms:
  • Fatigue
  • Asthenia
  • Lethargy
  • Renal Failure Acute
The patient was hospitalized. This opens a possibility that Sulfamethoxazole/trimethoprim could cause fatigue and that some male patients may be more susceptible.

Dehydration, Hypotension, Eosinophilia, Renal Failure Acute
A 58-year-old female patient (weight: NA) from US with the following symptoms: urinary tract infection started Sulfamethoxazole\trimethoprim treatment (dosage: NA) on Oct 18, 2010. Soon after starting Sulfamethoxazole\trimethoprim treatment, the consumer experienced several side effects, including:
  • Dehydration
  • Hypotension
  • Eosinophilia
  • 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 dehydration.

Asthenia, Upper Respiratory Tract Infection, Cough, Respiratory Tract Congestion, Nephropathy Toxic, Renal Failure Acute
This asthenia side effect was reported by a pharmacist from US. A 58-year-old male patient (weight:NA) experienced the following symptoms/conditions: infection.The patient was prescribed Sulfamethoxazole/trimethoprim (dosage: NA), which was started on Feb 20, 2013. Concurrently used drugs: NA..When starting to take Sulfamethoxazole/trimethoprim the consumer reported symptoms, such as:
  • Asthenia
  • Upper Respiratory Tract Infection
  • Cough
  • Respiratory Tract Congestion
  • Nephropathy Toxic
  • Renal Failure Acute
These side effects may potentially be related to Sulfamethoxazole/trimethoprim. The patient was hospitalized.

Pyrexia, Headache, Vomiting, Urticaria, Rash, Vision Blurred
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Sulfameth/trimethoprim (dosage: 1 Pill Twice Daily Taken By Mouth, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Pyrexia
  • Headache
  • Vomiting
  • Urticaria
  • Rash
  • Vision Blurred
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfameth/trimethoprim treatment in female patients, resulting in pyrexia side effect.

Diarrhoea, Panic Attack, Anxiety
This report suggests a potential Sulfamethoxazole/trimethoprim Diarrhoea, Panic Attack, Anxiety side effect(s) that can have serious consequences. A 41-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: infection and used Sulfamethoxazole/trimethoprim (dosage: NA) starting Jan 24, 2014. Soon after starting Sulfamethoxazole/trimethoprim the patient began experiencing various side effects, including:
  • Diarrhoea
  • Panic Attack
  • Anxiety
Drugs used concurrently: NA.The patient was hospitalized. Although Sulfamethoxazole/trimethoprim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as diarrhoea, may still occur.

Hypotension, Diarrhoea, Asthenia, Fatigue, Dizziness, Renal Failure Acute, Melaena
This Hypotension, Diarrhoea, Asthenia, Fatigue, Dizziness, Renal Failure Acute, Melaena problem was reported by a pharmacist from US. A 67-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Oct 13, 2013 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:
  • Hypotension
  • Diarrhoea
  • Asthenia
  • Fatigue
  • Dizziness
  • Renal Failure Acute
  • Melaena
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hypotension, may become evident only after a product is in use by the general population.

Nerve Injury
This is a report of a 25-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: staphylococcal infection and was treated with Sulfamethoxazole/tmp Ds (dosage: 20, Twice Daily, Mouth) starting May 18, 2013. Concurrently used drugs:
  • Thyroid
  • Adderall
Soon after that, the consumer experienced the following side effects:
  • Nerve Injury
This opens a possibility that Sulfamethoxazole/tmp Ds treatment could cause the above reactions, including nerve injury, and some male subjects may be more susceptible.

Pseudomembranous Colitis, Megacolon
A 32-year-old female patient (weight: NA) from US with the following symptoms/conditions: prophylaxis,leukaemia cutis started Sulfamethoxazole/trimethoprim treatment (dosage: Unk) on NS. Soon after starting Sulfamethoxazole/trimethoprim treatment, the subject experienced various side effects, including:
  • Pseudomembranous Colitis
  • Megacolon
Concurrently used drugs:
  • 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)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Sulfamethoxazole/trimethoprim.

1 of 52 

Top 10 Sulfameth Side Effects for Women

Women Side EffectsReports
Rash 51
Pyrexia 47
Nausea 44
Headache 43
Pain 43
Pruritus 43
Vomiting 31
Fatigue 30
Arthralgia 28
Dyspnoea 27

Top 10 Sulfameth Side Effects for Men

Men Side EffectsReports
Renal Failure Acute 157
Hyperkalaemia 108
Rash 96
Nausea 64
Pyrexia 52
Asthenia 46
Urticaria 40
Vomiting 39
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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    Sulfameth 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 Sulfameth

    Side Effects reported to FDA: 1287

    Sulfameth safety alerts: No

    Reported deaths: 31

    Reported hospitalizations: 496

    Latest Sulfameth clinical trials