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Review Zanaflex Safety Reports submitted to FDA

Total Zanaflex reports: 18.
Zanaflex FDA safety alerts: 2007 .
   Reported hospitalizations: 15.
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FDA Reported Zanaflex Side Effects: palpitations, memory impairment, depressed level of consciousness, coronary artery occlusion, confusional state, hallucination, visual, thinking abnormal, loss of consciousness, gait disturbance, fall, somnolence.
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Zanaflex Side Effects Report #5656102-5
Consumer or non-health professional from UNITED STATES reported ZANAFLEX problem on Feb 19, 2008. Female patient, 60 years of age, was diagnosed with fibromyalgia and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: amnesia, hallucinations, mixed, off label use, stress, weight fluctuation. ZANAFLEX dosage: unknown. During the same period patient was treated with VALIUM. Patient recovered.

Zanaflex Side Effects Report #5672367-8
ZANAFLEX problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 29, 2008. Female patient, 51 years of age, weighting 200.0 lb, was diagnosed with muscle spasms and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: feeling jittery, heart rate increased, withdrawal syndrome. ZANAFLEX dosage: 9 MG QID ORAL, (UP TO 50 MG DAILY (NOT THE PRESCRIBED AMOUNT) ORAL. During the same period patient was treated with METHADON, ANTIHYPERTENSIVES, INSULIN. Patient recovered.

Zanaflex Side Effects Report #5688120-5
Consumer or non-health professional from UNITED STATES reported ZANAFLEX problem on Mar 12, 2008. Male patient, 58 years of age, was diagnosed with arthralgia, back pain and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: knee arthroplasty, off label use, tachycardia. ZANAFLEX dosage: (4 MG BID ORAL). Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5612518-4
ZANAFLEX problem was reported by a Pharmacist from UNITED STATES on Feb 01, 2008. Male patient was diagnosed with pain, infection and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. ZANAFLEX dosage: 6MG -1.5 TABLETS- ONCE DAILY PO. During the same period patient was treated with LEVAQUIN. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5616293-9
Consumer or non-health professional from UNITED STATES reported ZANAFLEX problem on Dec 21, 2007. Female patient, weighting 160.0 lb, was diagnosed with muscle spasms and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, cyanosis, dizziness, fall, respiratory arrest, syncope, urinary incontinence. ZANAFLEX dosage: unknown. During the same period patient was treated with REMERON, EFEXOR. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5616304-0
ZANAFLEX problem was reported by a Physician from UNITED STATES on Jan 19, 2008. Male patient was diagnosed with muscle spasticity and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: accidental overdose, progressive multiple sclerosis. ZANAFLEX dosage: unknown. During the same period patient was treated with LIORESAL. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5601468-5
Physician from UNITED STATES reported ZANAFLEX problem on Jan 02, 2008. Male patient, 18 years of age, weighting 235.0 lb, was diagnosed with lumbar radiculopathy and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: rash. ZANAFLEX dosage: 4 MG QD AT BEDTIME. During the same period patient was treated with LYRICA. Patient recovered.

Zanaflex Side Effects Report #5643985-8
ZANAFLEX problem was reported by a Physician from UNITED STATES on Mar 15, 2007. Female patient was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: hypotension. ZANAFLEX dosage: unknown. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5538311-9
Consumer or non-health professional from UNITED STATES reported ZANAFLEX problem on Nov 19, 2007. Female patient was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, abnormal behaviour, amnesia, arthralgia, asthenia, blood chloride decreased, blood creatinine increased, blood potassium increased, blood sodium decreased. ZANAFLEX dosage: 8 MG QID ORAL. During the same period patient was treated with INSULIN, IMODIUM ADVANCED, ESTRACE, CYMBALTA, TRIAMTERENE, NADOLOL. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5543116-9
ZANAFLEX problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 20, 2007. Female patient was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: cyanosis, loss of consciousness, respiratory arrest. ZANAFLEX dosage: unknown. Patient recovered.

Zanaflex Side Effects Report #5578682-0
Consumer or non-health professional from UNITED STATES reported ZANAFLEX problem on Dec 27, 2007. Female patient, weighting 135.0 lb, was diagnosed with muscle spasms and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, respiratory arrest, skin discolouration. ZANAFLEX dosage: unknown. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5512654-7
ZANAFLEX problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 01, 2007. Male patient was diagnosed with muscle spasticity and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: back pain, device leakage, dizziness, gait disturbance, hypertonia, hypoaesthesia, liver function test abnormal, muscle spasms, musculoskeletal stiffness. ZANAFLEX dosage: unknown. During the same period patient was treated with BACLOFEN, KLONOCPIN. Patient recovered.

Zanaflex Side Effects Report #5480695-4
Physician from UNITED STATES reported ZANAFLEX problem on Sept 17, 2007. Female patient, 53 years of age, weighting 180.0 lb, was diagnosed with fibromyalgia, pain and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: chills, hot flush. ZANAFLEX dosage: 4 MG Q3H ORAL, 8 MG Q3H ORAL. During the same period patient was treated with CADIAN, GLIMEPIRIDE, ROXICODONE, ACIPHEX, REGLAN. Patient recovered.

Zanaflex Side Effects Report #5502785-X
ZANAFLEX problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 13, 2007. Male patient was diagnosed with muscle spasticity and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: abasia, abdominal injury, activities of daily living impaired, back pain, dizziness, gait disturbance, hypertonia, hypoaesthesia, liver disorder. ZANAFLEX dosage: unknown. During the same period patient was treated with BACLOFEN, KLONOPIN. Patient recovered.

Zanaflex Side Effects Report #5375855-7
Physician from UNITED STATES reported ZANAFLEX problem on June 25, 2007. Female patient, 66 years of age, was diagnosed with constipation and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: coronary artery occlusion, depressed level of consciousness, memory impairment, palpitations. ZANAFLEX dosage: unknown. During the same period patient was treated with ULTRAM, METFORMIN, LYRICA, BACLOFEN, ZELNORM. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5383670-3
ZANAFLEX problem was reported by a Consumer or non-health professional from UNITED STATES on June 20, 2007. Female patient, 45 years of age, weighting 200.0 lb, was diagnosed with dystonia and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: pulmonary thrombosis. ZANAFLEX dosage: unknown. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5375855-7
Physician from UNITED STATES reported ZANAFLEX problem on June 25, 2007. Female patient, 66 years of age, was diagnosed with constipation and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: coronary artery occlusion, depressed level of consciousness, memory impairment, palpitations. ZANAFLEX dosage: unknown. During the same period patient was treated with ULTRAM, METFORMIN, LYRICA, BACLOFEN, ZELNORM. Patient was hospitalized. Patient recovered.

Zanaflex Side Effects Report #5383670-3
ZANAFLEX problem was reported by a Consumer or non-health professional from UNITED STATES on June 20, 2007. Female patient, 45 years of age, weighting 200.0 lb, was diagnosed with dystonia and was treated with ZANAFLEX. After drug was administered, patient experienced the following problems/side effects: pulmonary thrombosis. ZANAFLEX dosage: unknown. Patient was hospitalized. Patient recovered.


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amnesia, hallucinations, mixed, off label use, stress, weight fluctuation, feeling jittery, heart rate increased, withdrawal syndrome, , was diagnosed with fibromyalgia and was diagnosed with muscle spasms and was diagnosed with arthralgia, back pain and