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Sulfa Side Effects

Common Sulfa Side Effects

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

Rash (222)
Pyrexia (220)
Renal Failure Acute (182)
Nausea (167)
Headache (135)
Hyperkalaemia (115)
Pruritus (107)
Vomiting (103)
Stevens-johnson Syndrome (98)
Fatigue (94)
Dyspnoea (93)
Asthenia (92)
Diarrhoea (91)
Pain (83)
Urticaria (79)
Chills (73)
Arthralgia (72)
Malaise (68)
Hypersensitivity (66)
Neutropenia (63)

➢ 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.

Sulfa Side Effects Reported to FDA

The following Sulfa 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 Sulfa 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.
Rash, Liver Function Test Abnormal, Neutropenic Sepsis, Hepatitis
on Mar 12, 2014 Male from GB , 40 years of age, was treated with Sulfasalazine. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: rash, liver function test abnormal, neutropenic sepsis, hepatitis. Sulfasalazine dosage: N/A.
Associated medications used:
  • 6-mercaptopurine (Unk)
  • Pentasa (Unk)
  • Co-codamol (Unk)
  • Difflam (Unk (spray))
  • Penicillin V (Unk)
Patient was hospitalized.

Renal Failure, Hyperkalaemia
Patient was taking Sulfamethoxazole/trimethoprim. Patient felt the following Sulfa side effects: renal failure, hyperkalaemia on Mar 11, 2014 from US Additional patient health information: Male , 75 years of age, weighting 213.4 lb, . Sulfamethoxazole/trimethoprim dosage: N/A. Patient was hospitalized.

Pulmonary Embolism
Adverse event was reported on Mar 11, 2014 by a Male taking Sulfasalazine (Dosage: 1 G, 2x/day) was diagnosed with and. Location: GB , 42 years of age, weighting 209.4 lb, After Sulfa was administered, patient encountered several Sulfa side effects: pulmonary embolism.
Multiple concurrent drugs taken:
  • Tinzaparin (Unk)
  • Warfarin (Unk)
Patient was hospitalized.

Stevens-johnson Syndrome, Toxic Epidermal Necrolysis, Rash
on Mar 06, 2014 Male from US , 54 years of age, weighting 251.3 lb, was diagnosed with and was treated with Sulfamethoxazole/trimethoprim 800 Mg/160. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: stevens-johnson syndrome, toxic epidermal necrolysis, rash. Sulfamethoxazole/trimethoprim 800 Mg/160 dosage: 1 Bid Oral.


Stevens-johnson Syndrome, Wound
on Mar 06, 2014 Male from US , 34 years of age, was diagnosed with and was treated with Sulfamethoxazole/trimethoprim. Patient felt the following Sulfa side effects: stevens-johnson syndrome, wound. Sulfamethoxazole/trimethoprim dosage: N/A. Patient was hospitalized.

Lupus-like Syndrome, Cerebral Infarction
Patient was taking Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: lupus-like syndrome, cerebral infarction on Mar 06, 2014 from US Additional patient health information: Female , 19 years of age, was diagnosed with and. Sulfasalazine dosage: 1.5 G, Daily. Patient was hospitalized.

Cerebral Infarction, Hemiparesis, Hypersensitivity, Headache, Pyrexia
Adverse event was reported on Mar 06, 2014 by a Female taking Sulfasalazine (Dosage: 1.5 G, Daily) was diagnosed with and. Location: US , 13 years of age, Directly after, patient experienced the unwanted or unexpected Sulfa side effects: cerebral infarction, hemiparesis, hypersensitivity, headache, pyrexia.

Ataxia, Peripheral Sensory Neuropathy, Neurotoxicity
on Mar 06, 2014 Male from US , 73 years of age, was diagnosed with and was treated with Sulfasalazine. Patient felt the following Sulfa side effects: ataxia, peripheral sensory neuropathy, neurotoxicity. Sulfasalazine dosage: 3 G, Daily.
Multiple prescriptions taken:
  • Prednisone (Unk)
Patient was hospitalized.

Peripheral Sensorimotor Neuropathy, Paraparesis, Paraesthesia, Muscular Weakness, Ataxia
on Mar 06, 2014 Female from US , 63 years of age, was diagnosed with and was treated with Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: peripheral sensorimotor neuropathy, paraparesis, paraesthesia, muscular weakness, ataxia. Sulfasalazine dosage: 1 G, 1x/day.
Multiple concurrent drugs taken:
  • Prednisolone (60 Mg, Alternate Day)
  • Prednisolone (15 Mg, Alternate Day)
  • Prednisolone (10 Mg, Alternate Day)
  • Prednisolone (7.5 Mg, Alternate Day)
  • Prednisolone (Unk)
  • Ferrous Sulphate (Unk)
Patient was hospitalized.

Hyponatraemia, Hypokalaemia
Patient was taking Sulfamethoxazole-trimethoprim, Ds. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: hyponatraemia, hypokalaemia on Mar 05, 2014 from US Additional patient health information: Male , 57 years of age, was diagnosed with and. Sulfamethoxazole-trimethoprim, Ds dosage: N/A.
Associated medications used:
  • Acetaminophen
  • Azithromycin
  • Budesonide
  • Dextrose
  • Emtricitabine/tenofovir
  • Etravirine
  • Heparin
  • Ipratropium/albuterol
Patient was hospitalized.

Leukoplakia Oral, Glossitis, Stomatitis
Adverse event was reported on Mar 06, 2014 by a Female taking Sulfasalazine (Dosage: Unk) was diagnosed with and. Location: DE , 68 years of age, Patient felt the following Sulfa side effects: leukoplakia oral, glossitis, stomatitis.

Pharyngitis, Dysphagia, Odynophagia, Dysphonia, Oral Candidiasis, Agranulocytosis
on Mar 04, 2014 Male from US , 68 years of age, was diagnosed with and was treated with Sulfamethoxazole And Trimethorpim. After Sulfa was administered, patient encountered several Sulfa side effects: pharyngitis, dysphagia, odynophagia, dysphonia, oral candidiasis, agranulocytosis. Sulfamethoxazole And Trimethorpim dosage: N/A. Patient was hospitalized.

Nausea, Vomiting, Hyperkalaemia, Bradycardia, Dialysis
on Mar 04, 2014 Male from US , 66 years of age, weighting 184.3 lb, was diagnosed with and was treated with Sulfamethoxazole/trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: nausea, vomiting, hyperkalaemia, bradycardia, dialysis. Sulfamethoxazole/trimethoprim dosage: N/A.
Associated medications used:
  • Spironolactone
Patient was hospitalized.

Oral Mucosal Discolouration, Paraesthesia Oral, Lip Swelling
Patient was taking Sulfamethoxazole/trimethoprim Tablets. Patient felt the following Sulfa side effects: oral mucosal discolouration, paraesthesia oral, lip swelling on Mar 04, 2014 from US Additional patient health information: Female , 35 years of age, . Sulfamethoxazole/trimethoprim Tablets dosage: 800 Mg/160 Mg.

Hepatic Necrosis
Adverse event was reported on Mar 01, 2014 by a Female taking Sulfadiazine (Dosage: N/A) was diagnosed with and. Location: FR , 53 years of age, After Sulfa was administered, patient encountered several Sulfa side effects: hepatic necrosis.

Palpitations, Dizziness, Dyspnoea, Penile Blister, Burns Second Degree
on Feb 24, 2014 Male from US , 46 years of age, weighting 260.0 lb, was diagnosed with and was treated with Sulfamethoxazole/trimethoprim 800/160. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: palpitations, dizziness, dyspnoea, penile blister, burns second degree. Sulfamethoxazole/trimethoprim 800/160 dosage: One Table Twice Daily.

Meningitis Aseptic, Pain In Extremity, Hypersensitivity, Rash Macular
on Feb 25, 2014 Female from TN , 37 years of age, was diagnosed with and was treated with Sulfasalazine. Patient felt the following Sulfa side effects: meningitis aseptic, pain in extremity, hypersensitivity, rash macular. Sulfasalazine dosage: 0.5 G, Daily. Patient was hospitalized.

Activities Of Daily Living Impaired, Interstitial Lung Disease, Gait Disturbance
Patient was taking Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: activities of daily living impaired, interstitial lung disease, gait disturbance on Feb 24, 2014 from US Additional patient health information: Female , weighting 164.0 lb, was diagnosed with and. Sulfasalazine dosage: 2 Tablets 4 Times A Day By Mouth.
Multiple concurrent drugs taken:
  • Omeprazole
  • Potassium
  • Loprazolam
  • Simvastatin
  • Setraline
  • Furosemide
  • Fish Oil


Meningitis Aseptic, Hypersensitivity, Rash Maculo-papular, Transaminases Increased, Oedema
Adverse event was reported on Feb 25, 2014 by a Female taking Sulfasalazine (Dosage: 500 Mg, Daily) was diagnosed with and. Location: TN , 49 years of age, Directly after, patient experienced the unwanted or unexpected Sulfa side effects: meningitis aseptic, hypersensitivity, rash maculo-papular, transaminases increased, oedema. Patient was hospitalized.

Meningitis Aseptic
on Mar 06, 2014 Male from TN , 41 years of age, was diagnosed with and was treated with Sulfasalazine. Patient felt the following Sulfa side effects: meningitis aseptic. Sulfasalazine dosage: 500 Mg, 2x/day.
Multiple prescriptions taken:
  • Prednisone (10 Mg, Daily)
Patient was hospitalized.

Meningitis Aseptic
on Feb 25, 2014 Female from TN , 34 years of age, was diagnosed with and was treated with Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: meningitis aseptic. Sulfasalazine dosage: 2 G, Daily. Patient was hospitalized.

Candida Infection, Agranulocytosis
Patient was taking Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: candida infection, agranulocytosis on Feb 25, 2014 from US Additional patient health information: Male , 68 years of age, was diagnosed with and. Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg dosage: N/A.

Renal Failure Acute, Hyperkalaemia
Adverse event was reported on Feb 18, 2014 by a Male taking Sulfamethoxazole/trimethoprim (Dosage: N/A) . Location: US , 94 years of age, weighting 143.3 lb, Patient felt the following Sulfa side effects: renal failure acute, hyperkalaemia.
Multiple prescriptions taken:
  • Lisinopril
Patient was hospitalized.

Hyperkalaemia
on Feb 18, 2014 Male from US , 71 years of age, was treated with Sulfamethoxazole/trimethoprim. After Sulfa was administered, patient encountered several Sulfa side effects: hyperkalaemia. Sulfamethoxazole/trimethoprim dosage: N/A. Patient was hospitalized.

Nausea, Asthenia, Hunger, Vomiting, Dry Mouth
on Feb 18, 2014 Female from US , 31 years of age, weighting 140.0 lb, was diagnosed with and was treated with Sulfamethoxazol/trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: nausea, asthenia, hunger, vomiting, dry mouth. Sulfamethoxazol/trimethoprim dosage: N/A.

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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


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  • 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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    Safety Alerts, Active Ingredients, Usage Information

    ABACAVIR ALBUTEROL AMIKACIN ATROPINE CAPREOMYC CLOPIDOGR CODEINE S CUPRIC SU EPHEDRINE FERRIC SU FERROUS S GENTAMICI HYOSCYAMI MAFENIDE MAGNESIUM MANGANESE MORPHINE NEOMYCIN NEOMYCIN, PAROMOMYC PHENELZIN POLYMYXIN PROTAMINE QUINIDINE QUININE S SILVER SU SODIUM SU SODIUM TH TERBUTALI TOBRAMYCI TRIMETHOP VINBLASTI VINCRISTI ZINC SULF

    Active Ingredient: ABACAVIR ALBUTEROL AMIKACIN ATROPINE BACITRACI BUSULFAN CAPREOMYC CLOPIDOGR CODEINE S CUPRIC SU DEXAMETHA EPHEDRINE FERRIC SU FERROUS S GALSULFAS GENTAMICI HYOSCYAMI IDURSULFA ISOSULFAN MAFENIDE MAGNESIUM MANGANESE MORPHINE NEOMYCIN PAROMOMYC PHENELZIN POLYMYXIN PREDNISOL PROTAMINE QUINIDINE QUININE S SILVER SU SODIUM TH SULFACETA SULFADIAZ SULFAMETH SULFANILA SULFASALA TERBUTALI TOBRAMYCI VINBLASTI VINCRISTI ZINC SULF

    More About Sulfa

    Side Effects reported to FDA: 2617

    Sulfa safety alerts: 2014 2012 2011 2010 2009 2008 2007 2006 2005 2003 2002 2000

    Reported deaths: 76

    Reported hospitalizations: 601

    Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets


    [Posted 01/18/2013]

    AUDIENCE: Pharmacy, Consumer

    ISSUE: Advance Pharmaceutical Inc. notified the public of a recall of one lot of Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle of Ferrous Sulfate Tablets, 325 mg contained Meclizine HCl 25 mg tablets. The lot of the Rugby Ferrous Sulfate is 12G468. Expiration date for the lot is 07/14. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate -- see Product Photo page. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.

    BACKGROUND: Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with kidney or liver dysfunction, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.

    Consumers who take three tablets daily of the defective product for treatment of iron deficiency would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose.

    RECOMMENDATION: Consumers who have the affected lot should not take the product. They may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300, Monday through Friday between 8:30 am and 4:30 pm ET.


    [01/17/2013 - Press Release - Advance Pharmaceutical]
    [01/17/2013 - Product Photos - FDA]

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