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Review Tizanidine Safety Reports submitted to FDA

Total Tizanidine reports: 23.
Tizanidine FDA safety alerts: 2007 .
Reported deaths: 6    Reported hospitalizations: 2.
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FDA Reported Tizanidine Side Effects: somnolence, completed suicide, heart rate decreased, oedema peripheral, headache, eyelid oedema, abdominal pain, convulsion, coma, cardio-respiratory arrest, apnoea.
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Tizanidine Side Effects Report #5677203-1
Pharmacist from UNITED STATES reported TIZANIDINE problem on Mar 06, 2008. Female patient, 43 years of age, was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, completed suicide, respiratory arrest. TIZANIDINE dosage: unknown. During the same period patient was treated with DOXEPIN. Patient died.

Tizanidine Side Effects Report #5679661-5
TIZANIDINE problem was reported by a Consumer or non-health professional from RUSSIAN FEDERATION on Mar 07, 2008. Female patient, 67 years of age, was diagnosed with back pain and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, asthenia, hypotension. TIZANIDINE dosage: (2 MG 1X). During the same period patient was treated with TIZANIDINE HYDROCHLORIDE. Patient recovered.

Tizanidine Side Effects Report #5690447-8
Pharmacist from UNITED STATES reported TIZANIDINE problem on Mar 31, 2008. Male patient, 44 years of age, was diagnosed with muscle spasticity and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: rash. TIZANIDINE dosage: 2MG BID PO. Patient recovered.

Tizanidine Side Effects Report #5691933-7
TIZANIDINE problem was reported by a Consumer or non-health professional from FINLAND on Mar 13, 2008. Male patient was diagnosed with back pain and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, erythema, loss of consciousness, myalgia, nausea, pallor. TIZANIDINE dosage: (4 MG 1X ORAL). During the same period patient was treated with PRONAXEN. Patient recovered.

Tizanidine Side Effects Report #5631726-X
Physician from ITALY reported TIZANIDINE problem on Jan 28, 2008. Female patient was diagnosed with back pain, ear infection and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: dyspnoea at rest, feeling abnormal, hyperglycaemia, iatrogenic injury. TIZANIDINE dosage: (4 MG ORAL). During the same period patient was treated with PREDNISONE, AIRTAL, AMOXICILLIN TRIHYDRATE, GLYBURIDE AND METFORMIN, LIVIAL, LANSOX, EUTIROX. Patient recovered.

Tizanidine Side Effects Report #5632004-5
TIZANIDINE problem was reported by a Consumer or non-health professional from GERMANY on Jan 28, 2008. Female patient was diagnosed with pain in extremity and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, blood glucose fluctuation, hepatic enzyme increased. TIZANIDINE dosage: 6 MG QD ORAL. During the same period patient was treated with HUMALOG, LEVEMIR. Patient recovered.

Tizanidine Side Effects Report #5632272-X
Physician from JAPAN reported TIZANIDINE problem on Jan 27, 2008. Female patient, weighting 112.4 lb, was diagnosed with muscle rigidity, pain, parkinsonism and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, bedridden, blood lactate dehydrogenase increased, decreased appetite, diabetes mellitus, diarrhoea. TIZANIDINE dosage: DF ORAL, 1 MG TID, ORAL, 0.3 MG FREQUENCY ORAL. During the same period patient was treated with TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE. Patient recovered.

Tizanidine Side Effects Report #5638216-9
TIZANIDINE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 18, 2007. Female patient, 42 years of age, weighting 135.0 lb, was diagnosed with muscle spasms and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: cold sweat, dizziness, feeling cold, loss of consciousness, post procedural complication, respiratory arrest, skin discolouration. TIZANIDINE dosage: unknown. During the same period patient was treated with EFFEXOR, REMERON, FEMIRON. Patient recovered.

Tizanidine Side Effects Report #5593954-1
Physician from ITALY reported TIZANIDINE problem on Dec 27, 2007. Female patient was diagnosed with back pain, ear infection and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, hyperglycaemia, iatrogenic injury. TIZANIDINE dosage: (4 MG ORAL). During the same period patient was treated with PREDNISONE, AIRTAL, AMOXICILLIN TRIHYDRATE, GLYBURIDE AND METFORMIN, LIVIAL, LANSOX, EUTIROX. Patient recovered.

Tizanidine Side Effects Report #5603311-7
TIZANIDINE problem was reported by a Health Professional from UNITED KINGDOM on Jan 07, 2008. Male patient, 83 years of age, weighting 136.7 lb, was diagnosed with muscle spasms and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: hypotension, hypoxia. TIZANIDINE dosage: 4 MG; ; ORAL, 8 MG; ; ORAL. During the same period patient was treated with ASPIRIN, CITALOPRAM HYDROBROMIDE, DIPYRIDAMOLE, RAMIPRIL. Patient recovered.

Tizanidine Side Effects Report #5605171-7
Consumer or non-health professional from UNITED STATES reported TIZANIDINE problem on Jan 07, 2008. Female patient, 52 years of age, was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, poisoning, respiratory arrest. TIZANIDINE dosage: unknown. During the same period patient was treated with FENTANYL, DOXEPIN, BUPROPION, FLUOXETINE, AMOXICILLIN, PREGABALIN, METHOCARBAMOL, ATORVASTATIN. Patient died.

Tizanidine Side Effects Report #5605172-9
TIZANIDINE problem was reported by a Physician from UNITED STATES on Jan 07, 2008. Female patient, 54 years of age, was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, completed suicide, poisoning, respiratory arrest. TIZANIDINE dosage: unknown. During the same period patient was treated with METOPROLOL TARTRATE. Patient died.

Tizanidine Side Effects Report #5605173-0
Physician from UNITED STATES reported TIZANIDINE problem on Jan 07, 2008. Female patient, 28 years of age, was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: completed suicide, poisoning. TIZANIDINE dosage: unknown. During the same period patient was treated with DILTIAZEM, BUPROPION, QUETIAPINE FUMARATE, CLONIDINE, ZIPRASIDONE, GABAPENTIN, DULOXETINE. Patient died.

Tizanidine Side Effects Report #5605176-6
TIZANIDINE problem was reported by a Physician from UNITED STATES on Jan 07, 2008. Female patient, 53 years of age, was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: completed suicide, poisoning. TIZANIDINE dosage: unknown. During the same period patient was treated with VENLAFAXINE, TRAMADOL, PREGABALIN. Patient died.

Tizanidine Side Effects Report #5605177-8
Physician from UNITED STATES reported TIZANIDINE problem on Jan 07, 2008. Male patient, 43 years of age, was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest. TIZANIDINE dosage: unknown. During the same period patient was treated with OXYCODONE, IBUPROFEN, ACETAMINOPHEN, CARISOPRODOL, PROMETHAZINE. Patient died.

Tizanidine Side Effects Report #5614082-2
TIZANIDINE problem was reported by a Health Professional from UNITED KINGDOM on Jan 14, 2008. Male patient, 83 years of age, was diagnosed with muscle spasms and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: hypotension, hypoxia. TIZANIDINE dosage: unknown. During the same period patient was treated with ASPIRIN, CITALOPRAM HYDROBROMIDE, DIPYRIDAMOLE, RAMIPRIL. Patient recovered.

Tizanidine Side Effects Report #5570154-2
Consumer or non-health professional from RUSSIAN FEDERATION reported TIZANIDINE problem on Nov 29, 2007. Female patient, 67 years of age, was diagnosed with back pain and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: asthenia, back pain, blood pressure decreased, decreased activity, loss of consciousness, nasopharyngitis. TIZANIDINE dosage: (2 MG 1X). Patient recovered.

Tizanidine Side Effects Report #5455175-2
TIZANIDINE problem was reported by a Consumer or non-health professional from PORTUGAL on Aug 29, 2007. Male patient was diagnosed with back pain and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, eyelid oedema, headache, lip swelling, oedema peripheral, rash erythematous, swelling face. TIZANIDINE dosage: unknown. During the same period patient was treated with DICLOFENAC, MISOPROSTOL. Patient was hospitalized. Patient recovered.

Tizanidine Side Effects Report #5406723-X
Consumer or non-health professional from UNITED KINGDOM reported TIZANIDINE problem on July 17, 2007. Male patient, 41 years of age, was diagnosed with muscle spasticity and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: myalgia. TIZANIDINE dosage: unknown. Patient recovered.

Tizanidine Side Effects Report #5412622-X
TIZANIDINE problem was reported by a Consumer or non-health professional from JAPAN on July 24, 2007. Female patient, 45 years of age, was diagnosed with multiple sclerosis, pyuria and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, body temperature decreased, gait disturbance, heart rate decreased, pain in extremity, pyuria, somnolence, urine output decreased. TIZANIDINE dosage: 3 MG. During the same period patient was treated with CIPROFLOXACIN. Patient recovered.

Tizanidine Side Effects Report #5427137-2
Consumer or non-health professional from PORTUGAL reported TIZANIDINE problem on Aug 23, 2007. Male patient, 39 years of age, was diagnosed with back pain and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, eyelid oedema, face oedema, headache, lip oedema, oedema peripheral, rash. TIZANIDINE dosage: unknown. During the same period patient was treated with MISOPROSTOL, DICLOFENAC. Patient was hospitalized. Patient recovered.

Tizanidine Side Effects Report #5387529-7
TIZANIDINE problem was reported by a Physician from GUATEMALA on June 28, 2007. Male patient, 27 years of age, was diagnosed with muscle spasms, pain and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: autonomic nervous system imbalance, hypertension. TIZANIDINE dosage: (4 MG 1X/8 HOURS ORAL). During the same period patient was treated with CATAFLAM. Patient recovered.

Tizanidine Side Effects Report #5387529-7
Physician from GUATEMALA reported TIZANIDINE problem on June 28, 2007. Male patient, 27 years of age, was diagnosed with muscle spasms, pain and was treated with TIZANIDINE. After drug was administered, patient experienced the following problems/side effects: autonomic nervous system imbalance, hypertension. TIZANIDINE dosage: (4 MG 1X/8 HOURS ORAL). During the same period patient was treated with CATAFLAM. Patient recovered.


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