DASPONE

N/A

Manufactured by Amneal Pharmaceuticals NY LLC

17,982 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DASPONE

DASPONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. The most commonly reported adverse reactions for DASPONE include OFF LABEL USE, DRUG INEFFECTIVE, PYREXIA, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DASPONE.

Top Adverse Reactions

OFF LABEL USE1,093 reports
DRUG INEFFECTIVE963 reports
PYREXIA445 reports
NAUSEA434 reports
FATIGUE431 reports
METHAEMOGLOBINAEMIA418 reports
DIARRHOEA389 reports
PNEUMONIA377 reports
DYSPNOEA357 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS343 reports
ANAEMIA341 reports
PAIN339 reports
RASH333 reports
CONDITION AGGRAVATED326 reports
TREATMENT FAILURE319 reports
PRODUCT USE IN UNAPPROVED INDICATION304 reports
ASTHENIA266 reports
HEADACHE264 reports
VOMITING261 reports
ACUTE KIDNEY INJURY234 reports
RENAL FAILURE224 reports
SEPSIS222 reports
DEATH218 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION200 reports
DIZZINESS195 reports
THROMBOCYTOPENIA193 reports
PRURITUS186 reports
ANXIETY185 reports
HYPERTENSION183 reports
DRUG INTERACTION175 reports
MALAISE175 reports
HYPOTENSION170 reports
NEUTROPENIA168 reports
ABDOMINAL PAIN164 reports
WEIGHT DECREASED163 reports
PANCYTOPENIA162 reports
COUGH161 reports
ARTHRALGIA158 reports
HAEMOLYTIC ANAEMIA153 reports
WEIGHT INCREASED143 reports
DRUG HYPERSENSITIVITY139 reports
PRODUCT DOSE OMISSION ISSUE137 reports
CHRONIC KIDNEY DISEASE135 reports
DEPRESSION135 reports
EMOTIONAL DISTRESS134 reports
URTICARIA134 reports
HYPOXIA129 reports
HAEMOGLOBIN DECREASED128 reports
PLATELET COUNT DECREASED128 reports
DECREASED APPETITE126 reports
CONSTIPATION124 reports
FALL123 reports
ERYTHEMA122 reports
FEBRILE NEUTROPENIA121 reports
BLOOD CREATININE INCREASED120 reports
DISEASE PROGRESSION120 reports
NEUROPATHY PERIPHERAL119 reports
RESPIRATORY FAILURE119 reports
WHITE BLOOD CELL COUNT DECREASED119 reports
RENAL IMPAIRMENT118 reports
OEDEMA PERIPHERAL116 reports
THERAPY NON RESPONDER112 reports
INFECTION111 reports
DEHYDRATION107 reports
ANHEDONIA105 reports
INTENTIONAL PRODUCT USE ISSUE105 reports
OXYGEN SATURATION DECREASED105 reports
CHEST PAIN104 reports
CONFUSIONAL STATE104 reports
DRUG INTOLERANCE103 reports
NO ADVERSE EVENT102 reports
BACK PAIN101 reports
CHILLS100 reports
DRUG INDUCED LIVER INJURY98 reports
LEUKOPENIA97 reports
PRODUCT USE ISSUE95 reports
INSOMNIA94 reports
BLOOD PRESSURE INCREASED92 reports
FEELING ABNORMAL92 reports
MUSCLE SPASMS91 reports
PULMONARY EMBOLISM91 reports
PAIN IN EXTREMITY90 reports
MYALGIA88 reports
OSTEOPOROSIS87 reports
URINARY TRACT INFECTION85 reports
DEEP VEIN THROMBOSIS81 reports
PERIPHERAL SWELLING81 reports
COVID 1980 reports
GAIT DISTURBANCE80 reports
TOXICITY TO VARIOUS AGENTS80 reports
BLISTER79 reports
DISEASE RECURRENCE78 reports
RENAL FAILURE ACUTE75 reports
HAEMOLYSIS74 reports
CATARACT73 reports
CELLULITIS73 reports
ADVERSE DRUG REACTION72 reports
SKIN EXFOLIATION72 reports
SKIN LESION72 reports
TREMOR72 reports

Report Outcomes

Out of 9,245 classified reports for DASPONE:

Serious 81.2%Non-Serious 18.8%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,236 (51.1%)
Male4,049 (48.8%)
Unknown6 (0.1%)

Reports by Age

Age 54153 reports
Age 55149 reports
Age 58149 reports
Age 65149 reports
Age 57141 reports
Age 66141 reports
Age 50129 reports
Age 60129 reports
Age 49126 reports
Age 62126 reports
Age 72125 reports
Age 44124 reports
Age 67123 reports
Age 70117 reports
Age 69116 reports
Age 63114 reports
Age 64113 reports
Age 37112 reports
Age 59109 reports
Age 35107 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DASPONE?

This profile reflects 17,982 FDA FAERS reports that mention DASPONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DASPONE?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, PYREXIA, NAUSEA, FATIGUE, METHAEMOGLOBINAEMIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DASPONE?

Labeling and FAERS entries often list Amneal Pharmaceuticals NY LLC in connection with DASPONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.