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Table 2 List of drugs causing ADRs

From: Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance

Marketed drug

Type of dosage form

Patients affected

Side effects

References

Oxycodone

Tablet- film coated and extended release

5%

Constipation, nausea, somnolence, dizziness, pruritis, vomiting, sweating, asthenia, dry mouth, headache

(Purdue2009)

Fentanyl

IV , patch

7.9%

Skin reactions, respiratory depression, mental changes, stroke

(Pasero2005; Mohammed2012) (Peng and Sandler1999, Prommer2009)

Clozapine

Tablets

2.7%

Cardiotoxicity, fever, chills, bodyache, flu symptoms, mouth-throat ulcers, cough, sore throat, rapid heart rate, rapid and shallow breathing.

(Cole et al.2009)

Methadone

Tablets

3.6%

Respiratory depression, QT prolongation, lacrimation, chilling, rhinorrhea, tachycardia, cramps, anorexia, nausea, dilated pupils, fluching

(Kung et al.2008) (Minino et al.2002)

Morphine

Injection

3%

Constipation, addiction, asphyxia, respiratory depression, renal failure, slow heartbeat, increase in B.P.

(Haupt and Jeste2006)

Acetaminophen

Capsules

1.5%

dark urine, loss of appetite, jaundice, damage to liver and death, difficulty in breathing, swelling of face and lips

(Huismen et al.2002)

Ethanercept

Syringe and subcutaneous injection

0.18%

Injection site pain, erythema reaction, rheumatoid arthritis, vestibular neuritis

(Orlando and Perkins2002)

Risperidone

Tablets

1.6- 1.7%

Stroke, heart failure, pneumonia, irregular heartbeat, seizure, white patches and sore in lips

(Holford1986)

Paclitaxel

Injectionand vials

0.01- 0.06%

Blurred vision, black stools, painful urination, ulcers, sores, red spots on skin, urticaria

(Orlando and Perkins2002)

Paroxetine

Tablets

0.9%

Bone pain, serious ventricular arrhythmias, agitation, hallucinations, tremors, increase in muscle tone

(Thisted et al.1986)

Rofecoxib

Tablets

2-3%

Increased arrhythmias, abdominal pain, tenderness, or discomfort, nausea, blood while vomiting, bloody, black, or tarry stools, unexplained weight gain, swelling or water retention, fatigue or lethargy, skin rash, itching, yellowing of skin or eyes, flu-like symptoms, or unusual bruising or bleeding.

(Krumholz et al.2007)

Warfarin

Tablets

1.2 -2.3%

Fatal bleeding, stroke, heart attack, abdominal pain, crawling, numbness, increase in menstrual flow, vaginal bleeding, paralysis, shortness of breath, diarrhea, skin blisters, hemorrhage, necrosis, purple toe syndrome

(Holbrook et al.2005)

Celecoxib

Capsules

1%

Risk of GI ulcerations, bleeding perforations, coronary artery disorder, cellulitis, angina pectoris, deep thrombo phlebritis, myocardial infarction, pneumonia, unstable angina

(Halpern2005)

Atorvastatin

Tablets

37 deaths

Liver damage, loss of appetite, allergic pruritis, muscles and joint pain, tendon problems, tiredness, jaundice

(Gaudreault et al.1982)

Misoprostol

Tablets

5-6%

Abortion, miscarriage, GI bleeding, multi organ failure, acute pain, haemodynamic instability, oesophageal necrosis, cardiac arrest, resuscitation efforts, birth defects

(Fu et al.1998)

Thalidomide

Capsules

10%

Somnolence, haematuria, urticaria, asthenia, pulmonary embolism, heart failure, bradycardia, tachycardia, cardiac arryhmias, deep vein thrombosis, seizures, orthostatic hypotension, birth defects (phocomelia)

(Ito et al.2010)

Insulin

Only in old patients injections subcutaneous insulin pump transdermal intranasal

Not available

Hypoglycemia (may result fatal if severe), low BP, irritability, fast heartbeat, convulsions, blurred visions

(FDA2009)

Aspirin

Tablets

25%

Excess acid secretion, stomach cramps, haemorrhage, bronchospasm, hepatitis interstitial, nephritis, inflammation of skin, allergic, abnormal liver functioning, clotted organs and tissues

(Schluter1989)

COX 2 inhibitors

Tablets

3- 3.9%

Myocardial infarction, fatal stroke, death from vascular events, hypertension, congestive heart failure, ulceration, bleeding from stomach, coronary artery blockage

(He et al.2005; Solomon et al.2004)

Ciprofloxacin

Tablets– extended release tablets oral suspension

0.65- 1.2%

High BP, angina, paroxysmal supraventicular tachycardia, prolonged QT interval, blood clot in brain, hepatitis, interstitial nephritis, migraine

(Carlo and Francesco1978)

Gentamicin

Tablets, cream, ointments, injectable

–

Severe kidney failure, nerve damage, permanent hearing loss, agitation, stomach pain, blood in urine, chest pain, stroke, coma, hallucinations, mental changes

(Carlo and Francesco1978)

Imipramine

Tablets

0.001% only on overdose

Slow heartbeat, abnormal heart rhythm, Low blood pressure, Inability to have an erection, hallucinations, involuntary quivering, difficult urination, nervous, confused, heart burn, diarrhea

(Delini et al.2007)

Fluoxetine

Capsules, tablets, liquids

0.014-0.62%

Severe blistering, peeling and red skin rash, uneven heartbeats, tremors, overactive reflexes, hallucination and seizures

(Michael and Ma2006)

Tetrabenazine

Tablets

0.5% only on overdose

Neuroleptic malignant syndrome, irregular heartbeats, parkinsonism, tardive dystonia, stroke sometimes, purple patches, mental changes, tightness in chest, shortness of breath, sore throat

(Jankovic and beach1997)

Propofol

Injectable

0.6-1.2%

Severe hypotension, bradycardia, pulmonary edema, systole, cardiac arrest, ventricular arrhythmias, respiratory acidosis, dysponea, bronchospasm

(Douketis et al.2007)