If you have come to this website because you are unwell, and have for some reason associated your problem with a product containing sulfamethoxazole and/or trimethoprim, you should seek medical advice. Emergency situations: Problems linked to this drug are often minor, or long-term and/or vague, but if you are experiencing burning sensations, stinging or blisters – particularly in the eyes, mouth, genitals or rectum – fever, rash or other symptoms causing you acute concern, you should seek IMMEDIATE medical supervision, if necessary at an emergency room. Most users suffer no adverse events, and serious problems are uncommon. But, in certain situations, adverse events may quickly become life-threatening and/or disabling. Your physician may not know this.

With trimethoprim, sulfamethoxazole is one of two ingredients in this drug – and the one considered most responsible for adverse events. Below is information on sulfamethoxazole side-effects given by Martindale, the authoritative reference work from the Pharmaceutical Society of Great Britain (33rd edition, April 2002). You can read personal stories in letters to The Sunday Times and in emails on this website: http://briandeer.com/septrin1.htm (Used with permission.)

Sulfamethoxazole (as in Bactrim, Septra, Septrin, etc)

Adverse effects and treatment

Note: definitions of terms are in parenthesis, colored orange and in italic print for clearer understanding of this document.

Nausea, vomiting, anorexia, and diarrhoea are relatively common following the administration of sulfamethoxazole and other sulfonamides.

Hypersensitivity reactions to sulfonamides have proved a problem. Fever is relatively common, and reactions involving the skin may include rashes, pruritis (itching)(photosensitivity reactions, exfoliative dermatitis (widespread scaling of the skin, often with itching, skin redness, and hair loss), and erythema nodosum (skin condition characterized by tender red nodules on the shins and legs). Severe, potentially fatal, skin reactions including toxic epidermal necrolysis (Toxic Epidermal Necrolysis or TEN – also called Lyell’s Syndrome – is a potentially life-threatening disorder characterized by extensive loss of skin resembling the effects of scalding. It is extremely rare, estimated to be 2.2 to 12.3 cases per million population in the United States. It begins with a 2-3 day period of flu-like symptoms including headache, body aches, fever, nausea, vomiting, congestion, cough, etc. One-third of patients develop conjunctivitis (pinkeye). Twenty-five to 28 percent of patients develope sore throat and/or itching. Eventually skin begins to slough off accompanied by burning pain, and there may be erosion of channels normally lined with mucus.) and the Stevens-Johnson syndrome (An allergic loss of much of the skin. Often this is fatal if not treated early.) have occurred in patients treated with sulfonamides. Dermatitis may also occur from contact of sulfonamides with the skin. Systemic lupus erythematosus, (a chronic inflammatory collagen disease affecting connective tissue (skin or joints.) particularly exacerbation of pre-existing disease, has also been reported.

Nephrotoxic (toxic to the kidneys) reactions including interstitial nephritis (Interstitial nephritis is a kidney disorder in which the spaces between the kidney tubules become swollen (inflamed). The inflammation can affect the kidneys’ function, including their ability to filter waste.) and tubular necrosis (Necrosis means death.), which may result in renal failure, have been attributed to hypersensitivity to sulfamethoxazole. Lumbar pain (of or relating to or near the part of the back between the ribs and the hipbones), haematuria (Hematuria: the presence of blood in the urine; often a symptom of urinary tract disease.), oliguria (Production of an abnormally small amount of urine.), and anuria (Anuresis: inability to urinate.), may also occur due to crystallisation in the urine of sulfamethoxazole or its less soluble acetylated metabolite. The risk of crystalluria can be reduced by the administration of fluids to maintain a high urine output. If necessary, alkalinisation of the urine by administration of sodium bicarbonate may increase solubility and aid the elimination of sulfonamides.

Blood disorders have occasionally occurred during treatment with the sulfonamides including sulfamethoxazole, and include agranulocytosis (An acute blood disorder often caused by radiation or drug therapy) characterized by severe reduction in granulocytes, a white blood cell.),  aplastic anaemia (Aplastic Anaemia is a rare but extremely serious disorder that results when the bone marrow , the spongy interior of the bones, fails to producing red and white blood cells and platelets.), thrombocytopenia, leucopenia, hypothrombinaemia, and eosinophilia. Many of these effects on the blood may result from hypersensitivity reactions. Sulfonamides may rarely cause cyanosis (Term used to describe the blueish or purplish skin colour that occurs when there is not enough oxygen in the blood. Can often be seen first in the lips and nailbeds.) due to methaemoglobinaemia (Methemoglobinemia is a disorder characterized by the presence of a higher than normal level of methemoglobin (metHb) in the blood. Methemoglobin is a form of hemoglobin that does not bind oxygen.) Acute haemolytic anaemia is a rare complication which may be associated with glucose-6-phosphate dehydrogenase deficiency.

Other adverse effects which may be manifestations of a generalised hypersensitivity reaction to sulfonamides include a syndrome resembling serum sickness (Serum sickness is a reaction to proteins in antiserum derived from an animal source. It is a type of hypersensitivity, specifically immune complex hypersensitivity), liver necrosis (Necrosis means death.), hepatomegaly and jaundice, myocarditis (Myocarditis: An inflammation of the heart muscle. Causes of “myocarditis” include virus infections, bacterial infections, reactions to some chemotherapy agents, alcohol poisoning from chronic alcohol abuse, and some auto-immune disorders.), pulmonary eosinophilia (Eosinophilia is the state of having a high concentration of eosinophils (eosinophil granulocytes) in the blood.) and fibrosing alveolitis (Idiopathic pulmonary fibrosis (IPF) (or cryptogenic fibrosing alveolitis (CFA)) is a chronic, progressive form of lung disease characterized by fibrosis of the supporting framework (interstitium) of the lungs.), and vasculitis (inflammation of a blood vessel) including polyarteritis nodosa (Periarteritis nodosa: a progressive disease of connective tissue that is characterized by nodules along arteries; nodules may block the artery and result in inadequate circulation to the particular area.Anaphylaxis (Extreme sensitivity to a substance such as a foreign protein or drug; A severe and rapid systemic allergic reaction to an allergen, causing a constriction of the trachea, preventing breathing; anaphylactic shock.) has been reported only very rarely.

Other adverse reactions that have been reported after the administration of sulfamethoxazole or other sulfonamides include hypoglycaemia (low blood sugar), hypothyrodism (low thyroid function), neurological reactions including aseptic meningitis (Aseptic meningitis, or sterile meningitis, is a condition in which the layers lining the brain, meninges, become inflamed and a pyogenic bacterial source is not to blame. Meningitis is diagnosed on a history of characteristic symptoms and certain examination findings (e.g., Kernig’s sign), ataxia (Lack of coordination while performing voluntary movements, which may appear to be clumsiness, inaccuracy, or instability), benign intracranial hypertension (Increased pressure within the brain in the absence of a tumor. Symptoms may include headache, nausea, vomiting, pulsating intracranial noises, singing in the ears, double vision, loss of visual accuracy, and even blindness.), convulsions, dizziness. drowsiness, fatigue, headache, insomnia, mental depression, peripheral or optic neuropathies, psychoses, tinnitus (Buzzing or ringing in the ear.), vertigo, and pancreatitis (Vertigo is feeling dizzy. Pancreatitis is an inflammation of the pancreas that may cause intense, persistent pain in the upper abdomen. Symptoms may include nausea, constipation, and jaundice.)

Sulfonamides may displace serum-bound biluribin, resulting in jaundice and kernicterus (a type of brain damage that includes athetoid cerebral palsy, hearing loss, and problems with vision and teeth) in premature neonates.

As with other antimicrobials, sulfamethoxazole may cause alterations of the bacterial flora in the gastrointestinal tract. There is, therefore, the possibility, although it appears to be small, that pseudomembranous colitis (Irritation and inflammation of the colon.) may occur.

Slow acetylators of sulfamethoxazole may be at greater risk of adverse reactions than fast acetylators.

Precautions

In patients receiving sulfamethoxazole, adequate fluid intake is necessary to reduce the risk of crystalluria; the daily urine output should be 1200 to 1500 mL or more. The administration of compounds which render the urine acidic may increase the risk of crystalluria; the risk may be reduced with alkaline urine.

Treatment with sulfonamides should be discontinued immediately a rash appears because of the danger of severe allergic reactions such as the Stevens-Johnson syndrome. (Stevens-Johnson syndrome is an unusual, severe reaction characterized by blistering and sloughing of the mucous membranes; the visceral organs may also be involved, and the condition can be fatal. The syndrome may result from the use of certain medications such as TMP-SMX, aka, Septra.)

Sulfamethoxazole should be given with care to patients with renal or hepatic impairment and is contra-indicated in patients with severe renal or hepatic failure or with blood disorders. Dosage reduction may be necessary in renal impairment. Complete blood counts and urinalyses with microscopic examination should be carried out particularly during prolonged therapy. Sulfamethoxazole should not be given to patients with a history of hypersensitivity to sulfonamides as cross-sensitivity may occur between drugs of this group. Care is generally advisable in patients with a history of allergy or asthma. Caution is also needed in the elderly, who may be more likely to have other risk factors for reactions. Some authorities consider sulfamethoxazole to be contra-indicated in lupus erythematosus as it may exacerbate the condition. Patients with glucose 6-phosphate dehydrogenase deficiency may be at risk of haemolytic reactions.

Sulfamethoxazole and other sulfonamides are not usually given to infants within 1 to 2 months of birth because of the risk of kernicterus (an abnormal accumulation of bile pigment in the brain and other nerve tissue; causes yellow staining and tissue damage); for the same reason, they are generally contra-indicated in women prior to delivery, and in breast-feeding mothers.

Patients with Aids may be particularly prone to adverse reactions, especially when sulfamethoxazole is given in combination with trimethoprim as co-trimoxazole.

Sulfonamides have been reported to interfere with some diagnostic tests, including those for urea, creatinine, and urinary glucose and urobilinogen.

Pharmaceutical Society of Great Britain, April 2002.

For more in-depth information go to this website http://briandeer.com/bactrim-septra.htm

Conclusion

I decided to look into this because my daughter had many adverse symptoms after completing her chemotherapy and I could not figure out what was causing these.  The last medication she was on was Septra, just on the weekends.  Her protocol required that she take this antibiotic for six months after completion of treatment.

When I read all of the information on the Brian Deer website about Septra I felt physically ill.  My daughter was having so many of the side effects listed but because of a heavy load of chemo, there was no way of identifying the source.

Psychosis, vasculitis, severe constipation, double vision, depression, headaches, back pain, insomnia, are many of the troubles that she has had for two and a half years during treatment!  These continued to plague her after finishing chemotherapy and this is how I discovered Brian Deer’s website.

With depression listed as a side effect I wonder how many patients further complicate their lives by using anti-depressants instead of getting off of this drug.

I am stunned that this kind of criminal-product is allowed to go to market and mass produced for patients.  Car companies get recalls – why is it that pharmaceutical companies can get away with products that have so many egregious side effects, some possibly fatal?  And why aren’t patients being warned – especially the parents of children being treated with this drug, who have trouble describing what they are feeling?

Against doctor’s orders, my daughter, Kayla is now off of this odious drug and harmony has now entered our home.  She now sleeps, eats normally, her double vision is gone, leg and back pain is gone, and she is just feeling good overall.

I am NOT advising you take the same actions.  But please, if you have been prescribed this drug from your doctor and are having side effects, print out this article and bring it to him for consultation.

Never accept a drug without first investigating side effects and other possible options.