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Dapsone Side Effects

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Common Dapsone Side Effects


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

Methaemoglobinaemia (31)
Dyspnoea (16)
Pyrexia (15)
Haemolytic Anaemia (14)
Oxygen Saturation Decreased (12)
Anaemia (11)
Blood Methaemoglobin Present (8)
Rash (7)
Chills (7)
Haemoglobin Decreased (7)
Haemolysis (7)
Nausea (7)
Stevens-johnson Syndrome (6)
Toxic Epidermal Necrolysis (6)
Renal Failure Acute (6)
Renal Failure (5)
Febrile Neutropenia (5)
Dizziness (5)
Asthenia (5)
Fatigue (5)

➢ 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.

Dapsone Side Effects Reported to FDA



Dapsone Side Effect Report#9851147
This is a report of a 36-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Dapsone (dosage: NA, start time: NS), combined with:
  • Primaquine
and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapsone treatment in male patients, resulting in Death side effect.
Dapsone Side Effect Report#9781421
Rash
This report suggests a potential Dapsone Rash side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hiv infection and used Dapsone (dosage: NA) starting
Oct 08, 2013. After starting Dapsone the patient began experiencing various side effects, including: RashAdditional drugs used concurrently: NA. Although Dapsone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Dapsone Side Effect Report#9697552
Nausea, Blister, Stevens-johnson Syndrome, Toxic Epidermal Necrolysis
This Nausea problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: fungal infection. On
Sep 25, 2013 this consumer started treatment with Dapsone (dosage: 4 Tablets Daily By Mouth). The following drugs were being taken at the same time: NA. When using Dapsone, the patient experienced the following unwanted symptoms/side effects: Nausea, Blister, Stevens-johnson Syndrome, Toxic Epidermal NecrolysisThe 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 Nausea, may become evident only after a product is in use by the general population.
Dapsone Side Effect Report#9690418
Cyanosis, Dyspnoea, Blood Disorder
This Cyanosis side effect was reported by a pharmacist from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Dapsone (drug dosage: NA), which was initiated on
Oct 19, 2013. Concurrently used drugs: NA..After starting to take Dapsone the consumer reported adverse symptoms, such as: Cyanosis, Dyspnoea, Blood DisorderThese side effects may potentially be related to Dapsone.
Dapsone Side Effect Report#9601983
Hypochromic Anaemia, Superinfection, Rash Pustular, Wound Complication
This is a report of a 57-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: hidradenitis, who was treated with Dapsone (dosage: 25 Mg. Qd, Oral?unk Prior To Admission, start time: NS), combined with:
  • Ascorbic Acid
  • Brimonidine
  • Dorzolamide/ Timolol
  • Latanoprost
  • Levothyroxine
  • Magnesium Oxide
  • Morphine Sulfate
  • Kc1 20 Meq
and developed a serious reaction and side effect(s): Hypochromic Anaemia, Superinfection, Rash Pustular, Wound Complication after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapsone treatment in male patients, resulting in Hypochromic Anaemia side effect. The patient was hospitalized.
Dapsone Side Effect Report#9402965
Blood Methaemoglobin Present, Hypoxia
This report suggests a potential Dapsone Blood Methaemoglobin Present side effect(s) that can have serious consequences. A female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: antifungal prophylaxis,toxoplasmosis prophylaxis and used Dapsone (dosage: NA) starting
May 30, 2013. After starting Dapsone the patient began experiencing various side effects, including: Blood Methaemoglobin Present, HypoxiaAdditional drugs used concurrently: NA. Although Dapsone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Methaemoglobin Present, may still occur.
Dapsone Side Effect Report#9300717
Haemolysis, Blood Pressure Decreased
This Haemolysis problem was reported by a pharmacist from US. A 17-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 13, 2013 this consumer started treatment with Dapsone (dosage: 100 Mg Bid Po). The following drugs were being taken at the same time: NA. When using Dapsone, the patient experienced the following unwanted symptoms/side effects: Haemolysis, Blood Pressure DecreasedThe 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 Haemolysis, may become evident only after a product is in use by the general population.
Dapsone Side Effect Report#9287964
Renal Failure, Pulmonary Thrombosis, Thrombosis, Blood Potassium Increased, Dialysis
This Renal Failure side effect was reported by a consumer or non-health professional from US. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: renal disorder.The patient was prescribed Dapsone (drug dosage: NA), which was initiated on
Aug 28, 2012. Concurrently used drugs: NA..After starting to take Dapsone the consumer reported adverse symptoms, such as: Renal Failure, Pulmonary Thrombosis, Thrombosis, Blood Potassium Increased, DialysisThese side effects may potentially be related to Dapsone. The patient was hospitalized and became disabled.
Dapsone Side Effect Report#9275129
Hypoxia, Methaemoglobinaemia, Transaminases Increased, Blood Bilirubin Increased, Lung Infiltration, Viral Infection, Graft Versus Host Disease
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: antifungal prophylaxis, who was treated with Dapsone (dosage: NA, start time:
Dec 11, 2012), combined with:
  • Acyclovir
  • Amlodipine
  • Calcium Carbonate-vitamin D2
  • Restasis
  • Magnesium Oxide
  • Xoycodone
  • Posaconazole
  • Ranitidine
and developed a serious reaction and side effect(s): Hypoxia, Methaemoglobinaemia, Transaminases Increased, Blood Bilirubin Increased, Lung Infiltration, Viral Infection, Graft Versus Host Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapsone treatment in female patients, resulting in Hypoxia side effect. The patient was hospitalized.
Dapsone Side Effect Report#9218659
Swelling Face, Pyrexia, Rash, Hepatic Enzyme Increased
This report suggests a potential Dapsone Swelling Face side effect(s) that can have serious consequences. A 28-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Dapsone (dosage: NA) starting
Feb 27, 2013. After starting Dapsone the patient began experiencing various side effects, including: Swelling Face, Pyrexia, Rash, Hepatic Enzyme IncreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Dapsone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Swelling Face, may still occur.
Dapsone Side Effect Report#9204043
Fluid Retention, Pulmonary Mass
This Fluid Retention problem was reported by a pharmacist from US. A 14-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: antifungal prophylaxis. On
Oct 29, 2012 this consumer started treatment with Dapsone (dosage: NA). The following drugs were being taken at the same time:
  • Calcium Carbonate
  • Docusate Sodium
  • Emla Cream
  • Lorazepam 2 Mg
  • Magnesium Oxide
  • Promethazine
When using Dapsone, the patient experienced the following unwanted symptoms/side effects: Fluid Retention, Pulmonary MassAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fluid Retention, may become evident only after a product is in use by the general population.
Dapsone Side Effect Report#9202291
Cough
This Cough side effect was reported by a pharmacist from US. A 20-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Dapsone (drug dosage: NA), which was initiated on
Oct 19, 2012. Concurrently used drugs:
  • Cyclosporine
  • Marinol
  • Protonix
.After starting to take Dapsone the consumer reported adverse symptoms, such as: CoughThese side effects may potentially be related to Dapsone.
Dapsone Side Effect Report#9190032
Febrile Neutropenia, Haemoglobin Decreased, Thrombocytopenia, Bone Marrow Failure
This is a report of a 6-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: antifungal prophylaxis, who was treated with Dapsone (dosage: 50 Mg Daily, start time:
Aug 31, 2012), combined with:
  • Cefepime
  • 6-mercaptopurine
  • Ondansetron
  • Lidocaine-prilocaine
  • Methotrexate
and developed a serious reaction and side effect(s): Febrile Neutropenia, Haemoglobin Decreased, Thrombocytopenia, Bone Marrow Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapsone treatment in female patients, resulting in Febrile Neutropenia side effect.
Dapsone Side Effect Report#9190023
Throat Irritation, Cytomegalovirus Viraemia, Pyrexia, Respiratory Rate Increased, Heart Rate Increased, Blood Pressure Systolic Decreased
This report suggests a potential Dapsone Throat Irritation side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Dapsone (dosage: NA) starting
May 31, 2012. After starting Dapsone the patient began experiencing various side effects, including: Throat Irritation, Cytomegalovirus Viraemia, Pyrexia, Respiratory Rate Increased, Heart Rate Increased, Blood Pressure Systolic DecreasedAdditional drugs used concurrently:
  • Calcitonin
  • Azathioprine
  • Cyclosporine
  • Ergocalciferol
  • Ferrous Sulfate
  • Gabapentin
  • Albuterol\ipratropium
  • Magnesium Oxide
Although Dapsone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Throat Irritation, may still occur.
Dapsone Side Effect Report#9189933
Oxygen Saturation Decreased, Blood Methaemoglobin Present
This Oxygen Saturation Decreased problem was reported by a pharmacist from US. A 9-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: antifungal prophylaxis. On
Nov 06, 2012 this consumer started treatment with Dapsone (dosage: NA). The following drugs were being taken at the same time:
  • Acyclovir
  • Restasis
  • Ergocalciferol
  • Magnesium Sulfate
  • Micafungin
  • Omeprazole
  • Prednisone
  • Tacrolimus
When using Dapsone, the patient experienced the following unwanted symptoms/side effects: Oxygen Saturation Decreased, Blood Methaemoglobin PresentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oxygen Saturation Decreased, may become evident only after a product is in use by the general population.
Dapsone Side Effect Report#9189740
Rash, Haemoglobin Decreased
This Rash side effect was reported by a pharmacist from US. A male patient (weight:NA) experienced the following symptoms/conditions: antifungal prophylaxis.The patient was prescribed Dapsone (drug dosage: 50 Mg Daily Po), which was initiated on
Sep 21, 2012. Concurrently used drugs:
  • Emla Cream
  • Cyclosporin
.After starting to take Dapsone the consumer reported adverse symptoms, such as: Rash, Haemoglobin DecreasedThese side effects may potentially be related to Dapsone.
Dapsone Side Effect Report#9189320
Methaemoglobinaemia
This is a report of a 6-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pneumocystis jirovecii pneumonia,prophylaxis, who was treated with Dapsone (dosage: NA, start time:
Sep 25, 2012), combined with: NA. and developed a serious reaction and side effect(s): Methaemoglobinaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapsone treatment in male patients, resulting in Methaemoglobinaemia side effect.
Dapsone Side Effect Report#9189306
Haemolytic Anaemia, Methaemoglobinaemia, Anaemia, Renal Failure Acute
This report suggests a potential Dapsone Haemolytic Anaemia side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: antifungal prophylaxis and used Dapsone (dosage: NA) starting
Oct 15, 2012. After starting Dapsone the patient began experiencing various side effects, including: Haemolytic Anaemia, Methaemoglobinaemia, Anaemia, Renal Failure AcuteAdditional drugs used concurrently:
  • Dexamethasone
  • Lenalidomide
  • Acyclovir
  • Amlodipine
  • Aspirin
  • Celecoxib
  • Metformin
  • Pravastatin
The patient was hospitalized. Although Dapsone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemolytic Anaemia, may still occur.
Dapsone Side Effect Report#9189276
Methaemoglobinaemia, Pneumonia
This Methaemoglobinaemia problem was reported by a health professional from US. A 11-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pneumocystis jirovecii pneumonia,prophylaxis. On
Sep 25, 2012 this consumer started treatment with Dapsone (dosage: NA). The following drugs were being taken at the same time: NA. When using Dapsone, the patient experienced the following unwanted symptoms/side effects: Methaemoglobinaemia, PneumoniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Methaemoglobinaemia, may become evident only after a product is in use by the general population.
Dapsone Side Effect Report#9189272
Methaemoglobinaemia
This Methaemoglobinaemia side effect was reported by a health professional from US. A 15-year-old female patient (weight:NA) experienced the following symptoms/conditions: antifungal prophylaxis.The patient was prescribed Dapsone (drug dosage: 100mg Daily Po), which was initiated on
Sep 28, 2012. Concurrently used drugs:
  • Food Supplement
  • Lactose-free Oral Liquid
  • Cholecalciferol (vitamin D3)
  • Mercaptopurine
  • Saline Flush Inj
  • Dextrose
  • Sodium Chloride
.After starting to take Dapsone the consumer reported adverse symptoms, such as: MethaemoglobinaemiaThese side effects may potentially be related to Dapsone.
Dapsone Side Effect Report#9189270
Methaemoglobinaemia
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Dapsone (dosage: NA, start time:
Sep 20, 2012), combined with:
  • Tylenol-codeine
  • Miralax
  • Docusate
  • Ondansetron
  • Mercaptopurine
  • Omeprazole
  • Methotrexate
and developed a serious reaction and side effect(s): Methaemoglobinaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapsone treatment in male patients, resulting in Methaemoglobinaemia side effect. The patient was hospitalized.
Dapsone Side Effect Report#9189199
Pyrexia, Blood Methaemoglobin Present
This report suggests a potential Dapsone 25 Mg Tablet Pyrexia side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: antifungal prophylaxis and used Dapsone 25 Mg Tablet (dosage: 50 Mg -2 Tablets- Daily Po) starting
Aug 23, 2012. After starting Dapsone 25 Mg Tablet the patient began experiencing various side effects, including: Pyrexia, Blood Methaemoglobin PresentAdditional drugs used concurrently:
  • Cefepime
  • Fexofenadine
  • Oxybutynin
  • Polyethylene
  • Glycol
  • Acetaminophen
  • Ondansetron
  • Mercaptopurine
Although Dapsone 25 Mg Tablet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pyrexia, may still occur.
Dapsone Side Effect Report#9181762
Pyrexia, Neutropenia, Oxygen Saturation Decreased, Methaemoglobinaemia
This Pyrexia problem was reported by a pharmacist from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 24, 2012 this consumer started treatment with Dapsone (dosage: NA). The following drugs were being taken at the same time:
  • Diphenhydramine
  • Acetaminophen
  • Mercaptopurine
  • Lidocaine-prilocaine
When using Dapsone, the patient experienced the following unwanted symptoms/side effects: Pyrexia, Neutropenia, Oxygen Saturation Decreased, MethaemoglobinaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pyrexia, may become evident only after a product is in use by the general population.
Dapsone Side Effect Report#9156589
Hypoxia, Blood Methaemoglobin Present
This Hypoxia side effect was reported by a pharmacist from US. A 16-year-old female patient (weight:NA) experienced the following symptoms/conditions: antifungal prophylaxis.The patient was prescribed Dapsone (drug dosage: NA), which was initiated on
Aug 23, 2012. Concurrently used drugs: NA..After starting to take Dapsone the consumer reported adverse symptoms, such as: Hypoxia, Blood Methaemoglobin PresentThese side effects may potentially be related to Dapsone.
Dapsone Side Effect Report#9154649
Methaemoglobinaemia, Pneumonia
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: antifungal prophylaxis, who was treated with Dapsone (dosage: NA, start time:
Aug 27, 2012), combined with:
  • Dexamethasone
  • Docusate Sodium
  • Hydrocodone/acetaminophen
  • Mercaptopurine
  • Methotrexate
  • Ondansetron
  • Miralex
  • Ranitidine
and developed a serious reaction and side effect(s): Methaemoglobinaemia, Pneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dapsone treatment in male patients, resulting in Methaemoglobinaemia side effect. The patient was hospitalized.


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The appearance of Dapsone 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.


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It is really important to keep track of your health 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

    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.

    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.

    Dapsone 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.

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    Dapsone Safety Alerts, Active Ingredients, Usage Information

    NDC49349-078
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDAPSONE
    NameDAPSONE
    Dosage FormTABLET
    RouteORAL
    On market since20101118
    LabelerREMEDYREPACK INC.
    Active Ingredient(s)DAPSONE
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassSulfone [EPC],Sulfones [Chemical/Ingredient]

    More About Dapsone

    Side Effects reported to FDA: 142

    Dapsone safety alerts: No

    Reported deaths: 5

    Reported hospitalizations: 72

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