Hydroxychloroquine sulfate
These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUIN SULFATE tablets, for oral use Initial U.S. Approval: 1955
6a06ad3d-2d6c-4e51-93f5-8f782b86975b
HUMAN PRESCRIPTION DRUG LABEL
Aug 31, 2023
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxychloroquine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
ADVERSE REACTIONS SECTION
6 ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections:
- Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions (5.1)]
- Retinal Toxicity [see Warnings and Precautions (5.2)]
- Serious Skin Reactions [see Warnings and Precautions (5.3)]
- Worsening of Psoriasis [see Warnings and Precautions (5.4)]
- Risks Associated with Use in Porphyria [see Warnings and Precautions (5.5)]
- Hematologic Toxicity [see Warnings and Precautions (5.6)]
- Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.7)]
- Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8)]
- Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9)]
- Hypoglycemia [see Warnings and Precautions (5.10)]
The following adverse reactions have been identified during post-approval use of 4 -aminoquinoline drugs, including hydroxychloroquine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- Blood and lymphatic system disorders: Bone marrow depression, anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia
- Cardiac disorders: Cardiomyopathy, cardiac failure, QT-interval prolongation, ventricular tachycardia, torsades de pointes, atrioventricular block, bundle branch block, sick sinus syndrome, pulmonary hypertension
- Ear and labyrinthdisorders: Vertigo, tinnitus, nystagmus, sensorineural hearing loss
- Eye disorders: Retinopathy, retinal pigmentation changes (typically bull's eye appearance), visual field defects (paracentral scotomas), macular degeneration, corneal edema, corneal opacities, decreased dark adaptation
- Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain
- General disorders: Fatigue
- Hepatobiliary disorders: Abnormal liver function tests, fulminant hepatic failure
- Immune system disorders: Urticaria, angioedema, bronchospasm
- Metabolism and nutrition disorders: Anorexia, hypoglycemia, weight loss
- Musculoskeletal and connective tissue disorders: Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction
- Nervous system disorders: Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor)
- Neuropsychiatric disorders: Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares)
- Skin and subcutaneous tissue disorders: Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)
The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact****Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SPL UNCLASSIFIED SECTION
Manufactured for:
Northstar Rx LLC
Memphis, TN 38141.
Manufactured by:
Zydus Lifesciences Ltd.
Ahmedabad, India.
Rev.: 08/23