Adverse Drug Reactions

Let us first understand the difference between Adverse Drug Reactions and Adverse Events.

Adverse Drug Reactions (ADR)- These reactions may occur acutely and chronically and can result from interactions with multiple medications.

Adverse Event- It is any negative medical occurrence that is associated with the use of a medication or a medical error.

Medical errors can cause enormous amount of fatalities .A recent John Hopkins University study reveals that approx 250000 die each year due to these medical errors.

According to some reports over 2 million are hospitalized or die each year due to ADR while 1000000 die each year because of drug reactions.

        For India the extrapolated figures would be 400000 death due to ADR  and 720000 adverse events per annum.

Incidence of serious ADR is 6.7% and of fatal adverse drug reaction is 0.32%.

Types of ADR

Dose related (Augmented),non-dose related (Bizarre),dose related and time related (chronic),time related (delayed), withdrawal (end of use) & failure of therapy (failure).

Hence it is very important to know the ADR of atleast common drugs before or advising it to someone.

Let’s Start,

 Montelukast – It is a leukotriene receptor antagonists (LTRAs)

ADR

• Ear and Labyrinth disorders- Otalgia,Otitis Media.
• Eye disorders- Myopia, Conjunctivitis.
• Gastrointestinal disorders- Diarrhoea,Nausea, Vomiting, Abdominal pain, Dyspepsia.
• General disorders- Pyrexia.
• Upper Respiratory Tract Infections- Acute Bronchitis, Influenza, Laryngitis, Pharyngitis, Sinusitis, Pneumonia.
• Skin and Sub cutaneous tissue disorders- Rash, Eczema or Atopic Dermatitis, Skin infection, Urticaria.

Bromohexine – This drug you may easily found written on various cough syrups.

ADR-

• Effect on Gastrointestinal system- Nausea, Vomiting, Diarrhoea, Upper Abdominal Pain.
• General disorders and admin site conditions- Sweating.
• Nervous System- Headache and Dizziness.

Ambroxol

Main action is as a mucolytic.

Mainly used in cough syrups and also used in form of Tab.

ADR

Rarely Steven Johnson Syndrome,Toxic Epidermal Necrolysis, Erythema multiform.

• Gastrointestinal disorders- Nausea, Vomiting, Diarrhoea, Dyspepsia, Dry mouth or throat, Abdominal pain, heart burn, oral or pharyngeal.

Anaphylactic reactions- Angioedema, Rash, Urticaria.

Dextromethorphan- Used in cough suppression.

ADR

• Gastrointestinal disorders- Abdominal pain, diarrhoea, nausea, vomiting, Gastrointestinal disturbance.

• Nervous system disorders- Dizziness, drowsiness, convulsion, psychomotor hyperactivity.
• Psychiatric disorders- Insomnia, confusional state.

Salbutamol- Use in acute bronchospasm and in severe asthma.

ADR

Tremor, nervousness, nausea, vomiting, tachycardia, palpitations, chest pain, , dizziness, headache, insomnia, inhalation site sensation, hypotension, increased sweating, flu like syndrome, Conjunctivitis.

Salmetrol

Used in chronic asthma and COPD.

ADR

Headache, influenza,  nasal congestion, pharyngitis, rhinitis, cough, headache, musculoskeletal pain and throat irritation.

Omeprazole- It is a PPI (proton pump inhibitor)

Used in ulcers, GERD, Zollinger-ellison Syndrome.

ADR

• Significant- Cutaneous lupus erythematous, SLE, osteoporosis-related fractures, carcinoma, Vit B 12 deficiency (long term use).
• Gastrointestinal disorders- Nausea, vomiting, diarrhoea, constipation, flatulence, abdominal pain.
• General disorders and admin site conditions- Peripheral edema.
• Nervous system disorders- Headache, dizziness, somnolence, vertigo.
• Skin and Sub cutaneous tissue disorders- Rash, pruritus.

Sucralfate

Used in treatment of Gastritis.

ADR

Headache, dizziness, drowsiness, insomnia, vertigo.

• Gastrointestinal disorders- Constipation, diarrhoea, nausea, vomiting, flatulence, indigestion, dry mouth.
• Effect on musculoskeletal system- Backpain.

Loperamide- It is a drug of choice for functional (non- infections diarrhea).

ADR

• Significant- Ileus, constipation, abdominal distension, bloody stool, syncope and ventricular tachycardia.
• Eye disorders- Rarely miosis.
• Gastrointestinal disorders- Flatulence, nausea, Dyspepsia, dry mouth, vomiting.
• Effect on Nervous System- Headache, dizziness, somnolence, loss of consciousness, co- ordination abnormality.

Metronidazole and Norfloxacin– Use to treat diarrhea caused by E.coli.

ADR

Gastrointestinal disturbances, rash, urticaria, pruritus, superinfection, metallic taste, headache, dizziness, transient leucopenia, glossitis, nausea, vomiting, constipation, headache, dizziness, fever and dry mouth.

Ondansetron

Mainly use as an anti-emetic drug and also use in nausea.

ADR

Chest pain, bradycardia, hypotension, hypoxia, transient elevation of liver enzymes, transient blurred vision.

• Gastrointestinal disorders- Constipation, diarrhea, hiccup, xerostomia.
• Renal and Urinary disorders- Urinary retention.
• General Disorders- Malaise, fatigue, fever, cold sensation.
• Nervous system disorders- Headache, dizziness, sedation and drowsiness.

Domperidone

Used in treatment of acute nausea and vomiting.

ADR

Elevated prolactin levels.

• Gastrointestinal disorders- Dry mouth, diarrhea, transient intestinal cramps.
• Nervous system disorders- Headache, migrane, dizziness, convulsions.
• Renal and Urinary Disorders- Urinary retention.
• Skin and Sub cutaneous tissue disorders- Rash, pruritus.

Atenolol

Used in hypertension.(It is a beta blocker).

ADR

• Cardiac Disorders- Bradycardia.
• Eye disorders- Dry eyes, visual disturbances.
• Gastrointestinal disorders- Nausea, dry mouth.
• Nervous system disorders- Dizziness, headache.
• Psychiatric disorders- Hallucinations, depression, nightmare, psychoses.

Amlodipine

It is a calcium channel blocker.Use in the treatment of hypertension, Prinzmetal’s angina.

ADR

Peripheral oedema, hypotension, angina.

• Blood and Lymphatic disorders- Leucopenia, Thrombocytopenia.
• Ear disorders- Tinnitus.
• Eye disorders- Visual disturbances, diplopia.
• Gastrointestinal disorders- Nausea, dyspepsia, diarrhea, constipation, abdominal pain.
• General disorders- Fatigue, weight gain.
• Nervous system disorders- Headache, dizziness.
• Renal and Urinary disorders- micturition

Ofloxacin

It is an antibiotic belonging to class fluoroquinolones.

Used in treatment of UTI, skin and soft tissue infection, acute PID, Lower respiratory tract infection, bronchitis, prostatitis

ADR

• Significant- Tendon rupture or tendinitis,hyperglycemia.
• Cardiac disorders- Chest pain.
• Ear and Labyrinth disorders- Vertigo, earache.
• Effect on eyes- Visual disturbances, blurred vision, dryness, pain, redness, photophobia, chemical conjunctivitis.
• Gastrointestinal disorders- Nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, dryness of mouth.
• General disorders- Fever.
• Nervous system disorders- Headache, dizziness and drowsiness.
• Vascular disorders- Phlebitis.
• Reproductive system disorders- vaginitis and genital pruritus.

Fluconazole

It is an antifungal drug belonging to class azole.

Mainly used in treatment of candidiasis ( oral, vaginal, oesophageal) and cryptococcol meningitis, dermatophytosis.

ADR

• Gastrointestinal disorders- Nausea, vomiting, diarrhea, abdominal pain, flatulence, dyspepsia, constipation, dry mouth.
• General disorders- fatigue, Malaise, fever.

Effect on immune system- Angioedema, urticaria.

• Effect on nervous system- Headache, dizziness, tremor, vertigo.
• Skin and Sub cutaneous disorders- pruritus, rash and increased sweating.
• Metabolic and nutrition disorders- Hyperlipidemia, hypokalaemia, hypercholesteremia, anorexia.

Itraconazole

It is also an antifungal drug belonging to class azoles.

ADR

• Significant- Heart failure, oedema, neuropathy, transient or permanent hearing loss, hepatotoxicity, hypersensitivity reactions.
• Blood and Lymphatic system disorders- Granulocytopenia, leukopenia.
• Cardiac disorders- Chest pain, tachycardia.
• Ear and Labyrinth disorders- Tinnitus.
• Eye disorders- Visual disturbance, diplopia.
• Hepatobiliary disorders- Jaundice, hepatitis.
• Gastrointestinal disorders- Nausea, dyspepsia, diarrhea, constipation, vomiting.
• Effects on Nervous system- Headache, dizziness, dysgeusia, paraesthesia.
• Renal and Urinary disorders- Urinary incontinence.
• Effects on skin and Sub cutaneous tissue- Rash, pruritus, photosensitivity, alopecia.

Ornidazole

Used in amoebiasis, amoebic liver abscess.

ADR

Somnolence, headache, nausea, vomiting, dizziness, tremor, rigidity, poor coordination, seizures, it, vertigo, temporary loss of consciousness, taste disturbances.

Paracetamol

Use in the treatment of fever, post immunisation pyrexia.

ADR

• Significant- Thrombocytopenia, leucopenia, neutropenia, pancytopenia, agranulocytosis, Angioedema.
• Gastrointestinal disorders- Nausea, vomiting, constipation.
• Nervous system disorders- Headache.
• Psychiatric disorders- Insomnia.
• Skin and Subcutaneous disorders- Erythema, flushing, pruritus, hepatotoxicity, acute renal tubular necrosis.

Contributor- Medico Rohan Barnwal