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Sulfa Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 2149 

Agranulocytosis, Herpes Oesophagitis, Febrile Neutropenia (8440315-3)
on May 18, 2012 Female from JAPAN , 65 years of age, was diagnosed with
  • rheumatoid arthritis
and was treated with Sulfasalazine. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: agranulocytosis, herpes oesophagitis, febrile neutropenia. Sulfasalazine dosage: Unk.
Associated medications used:
  • Prednisolone (Unk)
Patient was hospitalized.

Demyelinating Polyneuropathy, Gait Disturbance (8439539-0)
Patient was taking Sulfamethoxazole And Trimethoprim. Patient felt the following Sulfa side effects: demyelinating polyneuropathy, gait disturbance on Jun 10, 2012 from JAPAN Additional patient health information: Male , weighting 90.39 lb, was diagnosed with
  • pneumocystis jiroveci pneumonia
  • crohn's disease
and. Sulfamethoxazole And Trimethoprim dosage: N/A.
Multiple prescriptions taken:
  • Humira
  • Mesalamine (1.5g Daily)
  • Alendronate Sodium
  • Lansoprazole (15mg Daily)
Patient was hospitalized.

Gastroenteritis, Abdominal Pain, Blood Pressure Decreased, Maternal Exposure During Pregnancy, Premature Delivery, Vomiting, Aphagia, Dizziness (8438870-2)
Adverse event was reported on May 24, 2012 by a Female taking Sulfamethoxazole And Trimethoprim (Dosage: N/A) . Location: UNITED STATES , 32 years of age, After Sulfa was administered, patient encountered several Sulfa side effects: gastroenteritis, abdominal pain, blood pressure decreased, maternal exposure during pregnancy, premature delivery, vomiting, aphagia, dizziness.
Multiple concurrent drugs taken:
  • Isentress (Po)
  • Ibuprofen
  • Lopinavir And Ritonavir (Po)
Patient was hospitalized.

Pyrexia, Neutropenia (8438214-6)
on Jun 08, 2012 Female from UNITED KINGDOM , 75 years of age, weighting 162.5 lb, was diagnosed with
  • rheumatoid arthritis
and was treated with Sulfasalazine. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: pyrexia, neutropenia. Sulfasalazine dosage: 1 Gram. Patient was hospitalized.


Colitis Ulcerative, Glycosylated Haemoglobin Increased (8438211-0)
on Jun 12, 2012 Female from UNITED STATES , weighting 143.3 lb, was treated with Sulfasalazine. Patient felt the following Sulfa side effects: colitis ulcerative, glycosylated haemoglobin increased. Sulfasalazine dosage: 1000 Mg (two Tablets Of 500mg), 4x/day.
Multiple prescriptions taken:
  • Metformin (1000 Mg, 1x/day)
  • Lantus (60 Units Once A Day)
  • Multi-vitamins (Unk)
  • Lamictal (200 Mg (two Tablets Of 100mg), 1x/day)
  • Glipizide (10 Mg, 1x/day)
  • Hydrocodone (500 Mg, 3x/day)
  • Cymbalta (60 Mg, 2x/day)
  • Lyrica (75 Mg, 2x/day)
Patient was hospitalized.

Pruritus, Intraocular Pressure Increased, Urinary Tract Infection (8435539-5)
Patient was taking Sulfamethoxazole And Trimethoprim. After Sulfa was administered, patient encountered several Sulfa side effects: pruritus, intraocular pressure increased, urinary tract infection on Jun 13, 2012 from BRAZIL Additional patient health information: Female , 72 years of age, was diagnosed with
  • urinary tract infection
  • blood pressure increased
and. Sulfamethoxazole And Trimethoprim dosage: Unk.
Multiple concurrent drugs taken:
  • Naprix D (Two Tablets Daily)
  • Metoprolol Succinate (One Tablet Daily)
  • Xalatan (3 Ug (one Drop In Each Eye), 1x/day)
  • Euthyrox (50 Mg, One Tablet ,1x/day)
  • Omeprazole (20 Mg (one Tablet), Daily)


Vomiting, Rash, Nausea, Pyrexia, Pancytopenia, Hyponatraemia, Renal Failure (8435335-9)
Adverse event was reported on Jun 08, 2012 by a Female taking Sulfamethoxazole And Trimethoprim (Dosage: Bactrim Ds 1 Tablet, Bid, Po) was diagnosed with
  • cellulitis
and. Location: UNITED STATES , weighting 185.2 lb, Directly after, patient experienced the unwanted or unexpected Sulfa side effects: vomiting, rash, nausea, pyrexia, pancytopenia, hyponatraemia, renal failure. Patient was hospitalized.

Toxic Epidermal Necrolysis (8435168-3)
on Jun 06, 2012 Female from POLAND , 40 years of age, was diagnosed with
  • arthritis
and was treated with Sulfasalazine. Patient felt the following Sulfa side effects: toxic epidermal necrolysis. Sulfasalazine dosage: Unk.

C-reactive Protein Increased (8435165-8)
on Jun 06, 2012 Male from JAPAN , 69 years of age, was diagnosed with
  • rheumatoid arthritis
and was treated with Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: c-reactive protein increased. Sulfasalazine dosage: Unk. Patient was hospitalized.

Lymphocyte Stimulation Test Positive, Continuous Haemodiafiltration, Agranulocytosis, Septic Shock (8435046-X)
Patient was taking Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: lymphocyte stimulation test positive, continuous haemodiafiltration, agranulocytosis, septic shock on May 24, 2012 from JAPAN Additional patient health information: Male , 42 years of age, was diagnosed with
  • fungal infection
  • hypertension
and. Sulfamethoxazole And Trimethoprim dosage: 4 Df Per Oral.
Associated medications used:
  • Livalo (2 Mg Per Oral)
  • Atelec(cilnidipine) (10 Mg Oral)
  • Lansoprazole (Per Oral)
  • Prednisolone (17.5 Mg Per Oral)
  • Candesartan Cilexetil (4 Mg Per Oral)
  • Feburic (febuxostat) (10 Mg (10 Mg, 1-2) 30 Mg : 10 Mg (10mg, 1 In 1 D) Per Oral)
  • Onealfa (alfacalcidol) (0.5 Mcg Per Oral)


Deep Vein Thrombosis (8434820-3)
Adverse event was reported on Jun 06, 2012 by a Female taking Sulfamethoxazole And Trimethoprim (Dosage: 1 Tablet/ Bid) . Location: UNITED STATES , 40 years of age, weighting 190.0 lb, Patient felt the following Sulfa side effects: deep vein thrombosis.
Multiple prescriptions taken:
  • Hydrocodone Bitartrate + Acetaminophen (1 Tablet/ As Necessary)
  • Atrovent (2 Puff(s), Qid)
  • Albuterol Sulate (1 Neb (nebulizer)/ As Needed)
  • Drospirenone And Ethinyl Estradiol (Unk Unk, Qd)
  • Lisinoprilhydrochlorothiazide Ratiopharm (1 Tablet/ Daily)
  • Proair Hfa (2 Puff(s), Qid)
  • Prilosec (20 Mg, Bid)
  • Drospirenone And Ethinyl Estradiol
Patient was hospitalized.

Cutaneous Lupus Erythematosus (8433918-3)
on Jun 05, 2012 Female from FRANCE , 62 years of age, was diagnosed with
  • rheumatoid arthritis
and was treated with Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: cutaneous lupus erythematosus. Sulfasalazine dosage: 1 G, 4x/day.
Multiple concurrent drugs taken:
  • Humira (40 Mg, 1x3week)
  • Rabeprazole Sodium (10 Mg, Unk)
  • Valsartan (40 Mg, 1x/day)
Patient was hospitalized.

Pleural Effusion, Coccidioidomycosis (8432318-X)
on Jun 09, 2012 Female from UNITED STATES , 62 years of age, was treated with Sulfamethoxazole. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: pleural effusion, coccidioidomycosis. Sulfamethoxazole dosage: N/A.
Associated medications used:
  • Corticosteroids
  • Trimethoprim
  • Tacrolimus
  • Voriconazole (Unk)
  • Valganciclovir
  • Prednisone Tab
  • Basiliximab
  • Mycophenolate Mofetil


Stevens-johnson Syndrome (8430741-0)
Patient was taking Sulfamethoxazole And Trimethoprim. Patient felt the following Sulfa side effects: stevens-johnson syndrome on Jun 07, 2012 from JAPAN Additional patient health information: Female , weighting 99.21 lb, . Sulfamethoxazole And Trimethoprim dosage: N/A.
Multiple prescriptions taken:
  • Famotidine (20 Milligram;)
  • Acyclovir (200 Milligram;)
  • Dexamethasone
  • Acyclovir (200 Milligram;)
Patient was hospitalized.

Clostridium Difficile Colitis (8430495-8)
Adverse event was reported on Jun 06, 2012 by a Male taking Sulfamethoxazole And Trimethoprim (Dosage: N/A) was diagnosed with
  • urinary tract infection
and. Location: UNITED STATES , 85 years of age, weighting 113.5 lb, After Sulfa was administered, patient encountered several Sulfa side effects: clostridium difficile colitis.
Multiple concurrent drugs taken:
  • Ciprofloxacin Hydrochloride
Patient was hospitalized.

Confusional State, Inappropriate Antidiuretic Hormone Secretion, Hyponatraemia, Asthenia (8429697-6)
on May 23, 2012 Female from UNITED STATES , 79 years of age, was treated with Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: confusional state, inappropriate antidiuretic hormone secretion, hyponatraemia, asthenia. Sulfamethoxazole And Trimethoprim dosage: 3 Days Prior To Hospitalisation.
Associated medications used:
  • Citalopram Hydrobromide (7 Days Prior To Hospitalisation)
Patient was hospitalized.

Pain, Emotional Distress, Anxiety, Anhedonia, Fear Of Disease, Deep Vein Thrombosis (8429515-6)
on Jun 04, 2012 Female from UNITED STATES , 38 years of age, weighting 240.3 lb, was treated with Sulfamethoxazole And Trimethoprim Double Strength. Patient felt the following Sulfa side effects: pain, emotional distress, anxiety, anhedonia, fear of disease, deep vein thrombosis. Sulfamethoxazole And Trimethoprim Double Strength dosage: 800-160.
Multiple prescriptions taken:
  • Hydrocodone Bitartrate And Acetaminophen (5-500)
  • Yasmin (Unk)
  • Drospirenone And Ethinyl Estradiol (Unk)
Patient was hospitalized.

Pericardial Effusion, Atelectasis, Pulmonary Oedema, Pulmonary Embolism, Pulmonary Haemorrhage, Pulmonary Mass, Thrombosis In Device (8429349-2)
Patient was taking Sulfametthoxazole And Trimethoprim. After Sulfa was administered, patient encountered several Sulfa side effects: pericardial effusion, atelectasis, pulmonary oedema, pulmonary embolism, pulmonary haemorrhage, pulmonary mass, thrombosis in device on May 03, 2012 from UNITED STATES Additional patient health information: Male , 65 years of age, . Sulfametthoxazole And Trimethoprim dosage: N/A.
Multiple concurrent drugs taken:
  • Abiraterone/prednisone (prednisone, Abiraterone Acetate)
  • Kenalog 9triamcinolone Acetonide)
  • Vixodin (paracetamol, Hydrocodone Bitartrate)
  • Metamucil (plantago Ovata)
  • Prilosec
  • Provenge (Intravenous)
  • Ambien
Patient was hospitalized.

Eosinophilic Myocarditis (8428203-X)
Adverse event was reported on Jun 04, 2012 by a Female taking Sulfasalazine (Dosage: Unk) was diagnosed with
  • ankylosing spondylitis
and. Location: SAUDI ARABIA , 56 years of age, Directly after, patient experienced the unwanted or unexpected Sulfa side effects: eosinophilic myocarditis. Patient was hospitalized.

Lung Neoplasm, Organising Pneumonia, Infection (8426819-8)
on Jun 01, 2012 Male from JAPAN , weighting 171.7 lb, was diagnosed with
  • prophylaxis
  • gastrooesophageal reflux disease
  • rheumatoid arthritis
  • pneumocystis jiroveci pneumonia
and was treated with Sulfamethoxazole And Trimethoprim. Patient felt the following Sulfa side effects: lung neoplasm, organising pneumonia, infection. Sulfamethoxazole And Trimethoprim dosage: N/A.
Multiple prescriptions taken:
  • Rabeprazole Sodium
  • Humira
Patient was hospitalized.

Organising Pneumonia, Infection, Lung Neoplasm (8423415-3)
on Jun 01, 2012 Male from JAPAN , weighting 171.7 lb, was diagnosed with
  • rheumatoid arthritis
and was treated with Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: organising pneumonia, infection, lung neoplasm. Sulfasalazine dosage: N/A.
Multiple concurrent drugs taken:
  • Humira
  • Prednisolone
  • Sulfamethoxazole And Trimethoprim
  • Methotrexate
  • Humira
  • Alendronate Sodium
  • Alfacalcidol
  • Omeprazole
Patient was hospitalized.

Haemoptysis, Cardiac Arrest, Thrombosis, Feeling Abnormal (8423353-6)
Patient was taking Sulfamethoxazole And Trimethoprim. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: haemoptysis, cardiac arrest, thrombosis, feeling abnormal on May 30, 2012 from JAPAN Additional patient health information: Male , weighting 120.8 lb, . Sulfamethoxazole And Trimethoprim dosage: N/A.
Associated medications used:
  • Heparin Sodium
  • Alendronate Sodium
  • Oxygen
  • Tracleer (125 Mg, Bid)
  • Prednisolone
  • Tracleer (62.5 Mg, Qd)
  • Rabeprazole Sodium


Injection Site Pain, Liver Injury, Arthralgia, Abasia (8422507-2)
Adverse event was reported on May 31, 2012 by a Female taking Sulfasalazine (Dosage: 2 In The Am And 2 In Pm) was diagnosed with
  • inflammation
and. Location: UNITED STATES , 45 years of age, Patient felt the following Sulfa side effects: injection site pain, liver injury, arthralgia, abasia.
Multiple prescriptions taken:
  • Prednisone Tab
  • Humira


Schizoaffective Disorder (8422484-4)
on May 29, 2012 Male from GERMANY , 37 years of age, was treated with Sulfasalazine. After Sulfa was administered, patient encountered several Sulfa side effects: schizoaffective disorder. Sulfasalazine dosage: 2000 Mg, 1x/day.
Multiple concurrent drugs taken:
  • Diclofenac (75 Mg, 2x/day)
Patient was hospitalized.

Deafness Unilateral (8421969-4)
on May 31, 2012 Male from JAPAN , weighting 147.7 lb, was diagnosed with
  • fabry's disease
and was treated with Sulfadiazine. Directly after, patient experienced the unwanted or unexpected Sulfa side effects: deafness unilateral. Sulfadiazine dosage: Unk.
Associated medications used:
  • Lidocaine Hcl (Unk)
  • Ifenprodil Tartrate (60 Mg, Tid)
  • Fabrazyme (35 Mg, Q2w)
  • Benzalkonium Chloride (Unk)
  • Loxoprofen Sodium (60 Mg, Unk)
  • Metoclopramide (Unk)
  • Clostridium Butyricum (1 G, Unk)
  • Bucladesine Sodium (Unk)
Patient was hospitalized.

Showing 1-25 of 2149 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Sulfa 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: 2149. View Sulfa Adverse Reports

Sulfa safety alerts: 2013 2012 2011 2010 2009 2008 2007 2006 2005 2003 2002 2000

Reported deaths: 58

Reported hospitalizations: 506

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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