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MORPHINE SULFATE

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Morphine Sulfate Adverse Events Reported to the FDA Over Time

How are Morphine Sulfate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Morphine Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Morphine Sulfate is flagged as the suspect drug causing the adverse event.

Most Common Morphine Sulfate Adverse Events Reported to the FDA

What are the most common Morphine Sulfate adverse events reported to the FDA?

Somnolence
1117 (1.64%)
Overdose
1017 (1.5%)
Nausea
1005 (1.48%)
Vomiting
951 (1.4%)
Drug Ineffective
935 (1.37%)
Death
848 (1.25%)
Drug Abuse
798 (1.17%)
Completed Suicide
778 (1.14%)
Confusional State
722 (1.06%)
Pain
715 (1.05%)
Respiratory Arrest
671 (.99%)
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Constipation
659 (.97%)
Cardiac Arrest
647 (.95%)
Drug Toxicity
622 (.91%)
Hypotension
621 (.91%)
Respiratory Depression
599 (.88%)
Dyspnoea
592 (.87%)
Cardio-respiratory Arrest
587 (.86%)
Loss Of Consciousness
483 (.71%)
Coma
472 (.69%)
Drug Interaction
471 (.69%)
Multiple Drug Overdose
467 (.69%)
Headache
442 (.65%)
Unresponsive To Stimuli
430 (.63%)
Drug Withdrawal Syndrome
427 (.63%)
Depressed Level Of Consciousness
425 (.62%)
Dizziness
398 (.59%)
Diarrhoea
396 (.58%)
Lethargy
392 (.58%)
Sedation
384 (.56%)
Agitation
377 (.55%)
Medication Error
376 (.55%)
Product Quality Issue
376 (.55%)
Drug Hypersensitivity
367 (.54%)
Asthenia
361 (.53%)
Fall
355 (.52%)
Abdominal Pain
346 (.51%)
Hyperhidrosis
339 (.5%)
Pyrexia
337 (.5%)
Delirium
336 (.49%)
Fatigue
323 (.47%)
Insomnia
320 (.47%)
Dehydration
316 (.46%)
Renal Failure Acute
308 (.45%)
Pruritus
304 (.45%)
Hallucination
297 (.44%)
Pneumonia
296 (.44%)
Accidental Overdose
292 (.43%)
Anxiety
291 (.43%)
Mental Status Changes
288 (.42%)
Malaise
287 (.42%)
Oxygen Saturation Decreased
276 (.41%)
Miosis
266 (.39%)
Convulsion
263 (.39%)
Respiratory Failure
254 (.37%)
Back Pain
252 (.37%)
Weight Decreased
250 (.37%)
Condition Aggravated
247 (.36%)
Oedema Peripheral
247 (.36%)
Intentional Drug Misuse
244 (.36%)
Tachycardia
242 (.36%)
Chest Pain
234 (.34%)
Disorientation
230 (.34%)
Drug Abuser
230 (.34%)
Tremor
224 (.33%)
Renal Failure
220 (.32%)
Drug Effect Decreased
217 (.32%)
Depression
214 (.31%)
Pain In Extremity
214 (.31%)
Pulmonary Oedema
210 (.31%)
Drug Dependence
209 (.31%)
Heart Rate Increased
209 (.31%)
Feeling Abnormal
205 (.3%)
Substance Abuse
203 (.3%)
Withdrawal Syndrome
193 (.28%)
Myoclonus
186 (.27%)
Decreased Appetite
184 (.27%)
Respiratory Rate Decreased
182 (.27%)
Hypertension
180 (.26%)
Drug Exposure During Pregnancy
169 (.25%)
Rash
169 (.25%)
Drug Screen Positive
166 (.24%)
Hypoaesthesia
166 (.24%)
Aggression
165 (.24%)
Rhabdomyolysis
165 (.24%)
Anaemia
161 (.24%)
Hypoxia
160 (.24%)
Pneumonia Aspiration
158 (.23%)
Aspartate Aminotransferase Increase...
154 (.23%)
General Physical Health Deteriorati...
154 (.23%)
Urinary Retention
154 (.23%)
Suicide Attempt
153 (.22%)
Abdominal Pain Upper
150 (.22%)
Post Procedural Complication
150 (.22%)
Alanine Aminotransferase Increased
149 (.22%)
Incorrect Dose Administered
149 (.22%)
Restlessness
148 (.22%)
Apnoea
147 (.22%)
Urticaria
145 (.21%)
Hyperaesthesia
144 (.21%)
Inadequate Analgesia
141 (.21%)

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This graph shows the top adverse events submitted to the FDA for Morphine Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Morphine Sulfate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Morphine Sulfate

What are the most common Morphine Sulfate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Morphine Sulfate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Morphine Sulfate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Morphine Sulfate According to Those Reporting Adverse Events

Why are people taking Morphine Sulfate, according to those reporting adverse events to the FDA?

Pain
7041
Drug Use For Unknown Indication
2715
Product Used For Unknown Indication
2466
Back Pain
1163
Cancer Pain
957
Analgesic Therapy
365
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Breakthrough Pain
297
Procedural Pain
276
Pain Management
257
Abdominal Pain
244
Postoperative Analgesia
217
Arthralgia
202
Bone Pain
179
Analgesia
172
Pain In Extremity
157
Analgesic Effect
134
Headache
128
Neuralgia
123
Ill-defined Disorder
115
Fibromyalgia
109
Drug Abuse
108
Spinal Anaesthesia
101
Chest Pain
100
Abdominal Pain Upper
99
Sedation
89
Neck Pain
86
Anaesthesia
78
Rheumatoid Arthritis
77
Complex Regional Pain Syndrome
70
Arthritis
67
Musculoskeletal Pain
61
Osteoarthritis
58
Post Procedural Pain
55
Drug Abuser
52
Migraine
50
Epidural Anaesthesia
46
Surgery
45
Pain Prophylaxis
43
Neuropathy Peripheral
42
Prophylaxis
42
Dyspnoea
40
Sciatica
37
Crohns Disease
35
Intervertebral Disc Degeneration
35
Intervertebral Disc Protrusion
34
Premedication
34
Suicide Attempt
33
Back Disorder
32
Ankylosing Spondylitis
32
Myalgia
31
Accidental Exposure
30

Drug Labels

LabelLabelerEffective
Morphine SulfatePaddock Laboratories, Inc.08-OCT-09
Morphine SulfateAmphastar Pharmaceuticals, Inc.18-DEC-09
Morphine SulfateBaxter Healthcare Corporation18-FEB-10
Morphine Sulfate Extended Releasebryant ranch prepack18-MAR-10
Morphine Sulfate bryant ranch prepack26-MAR-10
Morphine SulfateETHEX Corporation14-MAY-10
DuramorphBaxter Healthcare Corporation17-MAY-10
Ms ContincrSTAT RX USA LLC09-JUL-10
Morphine SulfatePhysicians Total Care, Inc.04-AUG-10
Morphine SulfateWatson Laboratories, Inc.07-AUG-10
Morphine SulfatePD-Rx Pharmaceuticals, Inc.07-AUG-10
Morphine SulfatePD-Rx Pharmaceuticals, Inc.07-AUG-10
Morphine SulfatePD-Rx Pharmaceuticals, Inc.07-AUG-10
Morphine Sulfateextended ReleaseLake Erie Medical DBA Quality Care Products LLC19-AUG-10
Morphine Sulfateextended ReleaseLake Erie Medical DBA Quality Care Products LLC17-SEP-10
Morphine SulfateAmphastar Pharmaceuticals, Inc.23-SEP-10
Morphine Sulfateer ErLake Erie Medical DBA Quality Care Products LLC08-OCT-10
Ms ContinCardinal Health04-JAN-11
Morphine SulfateBryant Ranch Prepack14-JAN-11
Morphine SulfateBryant Ranch Prepack14-JAN-11
Ms ContinLake Erie Medical DBA Quality Care Products LLC17-JAN-11
Morphine SulfateMeridian Medical Technologies, Inc.03-FEB-11
Morphine SulfatePhysicians Total Care, Inc.07-FEB-11
Morphine SulfateWest-ward Pharmaceutical Corp.21-JUL-11
Morphine Sulfateextended-releaseLake Erie Medical Surgical & Supply DBA Quality Care Products LLC28-JUL-11
Morphine SulfateAmerican Health Packaging09-AUG-11
AvinzaSTAT RX USA LLC22-SEP-11
Infumorph 500West-ward Pharmaceutical Corp.11-OCT-11
Infumorph 200West-ward Pharmaceutical Corp.11-OCT-11
DuramorphWest-ward Pharmaceutical Corp.18-OCT-11
Morphine SulfateWatson Laboratories, Inc.14-NOV-11
AvinzaLake Erie Medical DBA Quality Care Products LLC16-NOV-11
Morphine SulfateHospira, Inc.17-NOV-11
Morphine Sulfateextended ReleaseLake Erie Medical DBA Quality Care Products LLC13-DEC-11
Morphine SulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLC13-DEC-11
Morphine Sulfate H.J. Harkins Company, Inc.13-DEC-11
Morphine Sulfateextended ReleaseLake Erie Medical DBA Quality Care Products LLC19-DEC-11
Morphine SulfateH.J. Harkins Company, Inc.29-DEC-11
Morphine SulfatePhysicians Total Care, Inc.11-JAN-12
Morphine SulfateRoxane Laboratories, Inc27-JAN-12
Morphine SulfateRoxane Laboratories, Inc27-JAN-12
Morphine SulfateerLake Erie Medical & Surgical Supply DBA Quality Care Products LLC10-FEB-12
Morphine SulfateVistaPharm Inc.24-FEB-12
Morphine SulfateHospira, Inc.05-MAR-12
Morphine SulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLC19-MAR-12
Morphine Sulfate Extended-releaseLake Erie Medical & Surgical Supply DBA Quality Care Products LLC20-MAR-12
Morphine SulfateSTAT Rx USA LLC23-APR-12
Morphine Sulfate Extended-releaseSTAT Rx USA LLC24-APR-12
Morphine Sulfateextended ReleaseRhodes Pharmaceuticals L. P.12-MAY-12
Morphine SulfateSTAT Rx USA LLC31-MAY-12
Morphine SulfateHospira, Inc.06-JUN-12
Morphine Sulfate InjectionHospira, Inc.28-JUN-12
Morphine SulfateMallinckrodt, Inc.01-JUL-12
Morphine SulfateMylan Pharmaceuticals Inc.01-JUL-12
Morphine SulfateActavis Elizabeth LLC08-JUL-12
EmbedaKing Pharmaceuticals Inc.16-JUL-12
AvinzaKing Pharmaceuticals, Inc.16-JUL-12
AvinzaKing Pharmaceuticals, Inc.16-JUL-12
Morphine SulfateQualitest Pharmaceuticals19-JUL-12
KadianActavis Kadian LLC27-JUL-12
Morphine SulfateMallinckrodt, Inc.31-JUL-12
Morphine SulfateHospira, Inc.30-AUG-12
Morphine SulfateHospira, Inc.04-SEP-12
Ms ContinPurdue Pharma LP12-SEP-12
Morphine SulfatePaddock Laboratories, LLC26-SEP-12
Morphine SulfatePaddock Laboratories, LLC02-OCT-12
Morphine Sulfateextended-releaseBryant Ranch Prepack12-OCT-12
Morphine SulfateBryant Ranch Prepack12-OCT-12
AvinzaBryant Ranch Prepack23-OCT-12
AvinzaBryant Ranch Prepack23-OCT-12
AvinzaBryant Ranch Prepack23-OCT-12
Morphine Sulfateextended ReleaseBryant Ranch Prepack24-OCT-12
Morphine SulfateCantrell Drug Company18-NOV-12
Morphine SulfateCantrell Drug Company30-NOV-12
Morphine SulfateCantrell Drug Company03-DEC-12
Morphine SulfatePar Pharmaceutical Inc.13-DEC-12
Morphine SulfateLannett Company, Inc.27-DEC-12
Morphine SulfateCantrell Drug Company27-DEC-12
Morphine Sulfate International Medication Systems, Limited 10-JAN-13
Morphine SulfateSafecor Health, LLC16-JAN-13
Morphine Sulfateextended ReleaseBryant Ranch Prepack17-JAN-13
Morphine Sulfateextended ReleaseBryant Ranch Prepack17-JAN-13
KadianBryant Ranch Prepack18-JAN-13
KadianBryant Ranch Prepack18-JAN-13
Morphine SulfateBryant Ranch Prepack05-FEB-13
Morphine Sulfateextended ReleaseLake Erie Medical DBA Quality Care Products LLC12-FEB-13
Morphine SulfateCantrell Drug Company19-MAR-13
Morphine Sulfateextended ReleaseLake Erie Medical DBA Quality Care Products LLC21-MAR-13
Morphine SulfateCantrell Drug Company05-APR-13
Morphine SulfateCantrell Drug Company05-APR-13
Morphine SulfateDispensing Solutions, Inc.08-APR-13
Morphine SulfateCantrell Drug Company01-MAY-13

Morphine Sulfate Case Reports

What Morphine Sulfate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Morphine Sulfate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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