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Review Ritonavir Safety Reports submitted to FDA

Total Ritonavir reports: 215.
Ritonavir FDA safety alerts: 2003 2004 2005 2006 2007 2008 .
Reported deaths: 59    Reported hospitalizations: 127.
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FDA Reported Ritonavir Side Effects: death, immune reconstitution syndrome, abortion spontaneous, osteonecrosis, diarrhoea, hepatitis b, disorientation, kaposi's sarcoma, electrocardiogram qt prolonged, convulsion, ascites.
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Ritonavir Side Effects Report #5303262-1
Consumer or non-health professional from JAPAN reported RITONAVIR problem on Apr 11, 2007. Male patient, 27 years of age, was diagnosed with hiv infection and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: appendicitis. RITONAVIR dosage: unknown. During the same period patient was treated with TENOFOVIR, LAMIVUDINE, FOSAMPRENAVIR. Patient recovered.

Ritonavir Side Effects Report #5303660-6
RITONAVIR problem was reported by a Health Professional from FRANCE on Apr 13, 2007. Female patient, 66 years of age, was diagnosed with hiv infection, dyspnoea, arrhythmia and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, cushing's syndrome, malaise, orthostatic hypotension, tachycardia, vestibular disorder. RITONAVIR dosage: unknown. During the same period patient was treated with FLUTICASONE, AMIODARONE, FLUINDIONE. Patient was hospitalized. Patient recovered.

Ritonavir Side Effects Report #5306305-4
Consumer or non-health professional from reported RITONAVIR problem on Apr 20, 2007. Male patient, weighting 249.1 lb, was diagnosed with hiv infection, depression, anaemia, tinea pedis and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: cerebellar atrophy, cerebral atrophy, cerebral ischaemia, disorientation, partial seizures, transient ischaemic attack. RITONAVIR dosage: unknown. During the same period patient was treated with VIREAD, LAMIVUDINE, BUSPIRONE, CITALOPRAM HYDROBROMIDE, EPOETIN ALFA, SPECTRAZOLE. Patient recovered.

Ritonavir Side Effects Report #5306309-1
RITONAVIR problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 17, 2007. Male patient, 43 years of age, was diagnosed with hiv infection and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: immune reconstitution syndrome, pulmonary sarcoidosis. RITONAVIR dosage: unknown. During the same period patient was treated with ATAZANAVIR SULPHATE, EMTRICITABINE, ALBUTEROL, BECLOMETHASONE DIPROPIONATE, ANTIHYPERTENSIVES, VITAMIN, RISEDRONATE, FLUOXETINE. Patient was hospitalized. Patient recovered.


Ritonavir Side Effects Report #5307669-8
Consumer or non-health professional from IRELAND reported RITONAVIR problem on Apr 16, 2007. Female patient, weighting 158.1 lb, was diagnosed with hiv infection, antifungal prophylaxis, toxoplasmosis prophylaxis, anxiety, tachycardia and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus chorioretinitis, immune reconstitution syndrome. RITONAVIR dosage: unknown. During the same period patient was treated with LAMIVUDINE, BACTRIM, CLARITHROMYCIN, HYDROXYZINE, METOPROLOL SUCCINATE. Patient was hospitalized. Patient recovered.

Ritonavir Side Effects Report #5309237-0
RITONAVIR problem was reported by a Health Professional from FRANCE on Apr 12, 2007. Male patient, weighting 180.8 lb, was diagnosed with hiv infection and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: laryngeal cancer. RITONAVIR dosage: unknown. During the same period patient was treated with APTIVUS, ENFUVIRTIDE, EMTRICITABINE. Patient was hospitalized and became disabled. Patient recovered.

Ritonavir Side Effects Report #5309482-4
Consumer or non-health professional from UNITED KINGDOM reported RITONAVIR problem on Apr 20, 2007. Male patient, 26 years of age, was diagnosed with hiv infection and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: acute psychosis. RITONAVIR dosage: unknown. During the same period patient was treated with ATAZANAVIR SULPHATE. Patient recovered.

Ritonavir Side Effects Report #5312887-9
RITONAVIR problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Apr 20, 2007. Male patient, 44 years of age, was diagnosed with hiv infection and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: hypomania. RITONAVIR dosage: unknown. During the same period patient was treated with ATAZANAVIR SULPHATE. Patient recovered.

Ritonavir Side Effects Report #5254645-X
Pharmacist from UNITED STATES reported RITONAVIR problem on Feb 22, 2007. Male patient, 47 years of age, was diagnosed with hiv infection and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: hepatitis b. RITONAVIR dosage: unknown. During the same period patient was treated with APTIVUS, TRUVADA, FUZEON, PREZISTA. Patient was hospitalized. Patient recovered.


Ritonavir Side Effects Report #5254955-6
RITONAVIR problem was reported by a Consumer or non-health professional from on Feb 15, 2007. Male patient, weighting 249.1 lb, was diagnosed with hiv infection, depression, anaemia, tinea pedis and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: disorientation. RITONAVIR dosage: unknown. During the same period patient was treated with VIREAD, ZIDOVUDINE W, BUSPIRONE, CITALOPRAM HYDROBROMIDE, EPOETIN ALFA, SPECTRAZOLE. Patient recovered.

Ritonavir Side Effects Report #5266480-7
Consumer or non-health professional from IRELAND reported RITONAVIR problem on Mar 09, 2007. Female patient, weighting 158.1 lb, was diagnosed with hiv infection, antifungal prophylaxis, toxoplasmosis prophylaxis, anxiety, tachycardia and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: immune reconstitution syndrome. RITONAVIR dosage: unknown. During the same period patient was treated with LAMIVUDINE, BACTRIM, CLARITHROMYCIN, HYDROXYZINE, METOPROLOL SUCCINATE. Patient was hospitalized. Patient recovered.

Ritonavir Side Effects Report #5266481-9
RITONAVIR problem was reported by a Physician from UNITED STATES on Mar 06, 2007. Male patient, 50 years of age, was diagnosed with hiv infection, acquired immunodeficiency syndrome and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: cerebral infarction, disorientation, gastrointestinal disorder, haemorrhage intracranial. RITONAVIR dosage: unknown. During the same period patient was treated with APTIVUS, PREZISTA, TRUVADA, BACTRIM. Patient was hospitalized and became disabled. Patient recovered.

Ritonavir Side Effects Report #5273090-4
Physician from UNITED STATES reported RITONAVIR problem on Mar 13, 2007. Male patient, 50 years of age, was diagnosed with hiv infection, acquired immunodeficiency syndrome and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: cerebral infarction, disorientation, haemorrhage intracranial. RITONAVIR dosage: unknown. During the same period patient was treated with APTIVUS, PREZISTA, TRUVADA, BACTRIM. Patient was hospitalized and became disabled. Patient recovered.

Ritonavir Side Effects Report #5276282-3
RITONAVIR problem was reported by a Health Professional from FRANCE on Mar 16, 2007. Female patient, 62 years of age, was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: oral discomfort, rash maculo-papular, skin burning sensation. RITONAVIR dosage: unknown. During the same period patient was treated with APTIVUS, NEVIRAPINE, VALPROATE, BROMAZEPAM, ZOPICLONE, TRUVADA. Patient was hospitalized. Patient recovered.


Ritonavir Side Effects Report #5282064-9
Consumer or non-health professional from FRANCE reported RITONAVIR problem on Mar 23, 2007. Male patient, 37 years of age, was diagnosed with systemic antiviral treatment, routine health maintenance and was treated with RITONAVIR. After drug was administered, patient experienced the following problems/side effects: renal failure. RITONAVIR dosage: unknown. During the same period patient was treated with CLINDAMYCIN, PYRIMETHAMINE, FLUCONAZOLE, FOSCARNET, LAMIVUDINE, STAVUDINE. Patient recovered.

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