The preliminary analysis of SUSARs from the PvPI database reveals that the following drugs are associated with the risks as given below.
S.No |
Suspected Drugs |
Indication |
Adverse Reactions |
1 |
Phenytoin |
Generalized tonic-clonic seizures; partial seizures; status epilepticus
|
Angioedema |
2 |
Phenytoin |
Generalized tonic-clonic seizures; partial seizures; status epilepticus
|
Osteoporosis |
3 |
Nicorandil |
Angina Pectoris, Vasodialator |
Risk of ulcer complication |
4 |
Olanzapine |
Schizophrenia, acute mania episodes in bipolar disorder
|
Hyponatraemia |
5 |
Crizotinib |
Locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) |
Risk of cardiac failure |
6 |
Sunitinib & Pazopanib |
|
Cardiac Dysfunction |
7 |
Ambroxol |
|
Anaphylactic Reactions, SJS/ TEN, Scars including Erythema Multiforme |
8 |
Rabies Vaccine |
|
Erythema Multiforme/ Stevens–Johnson syndrome |
9 |
Sodium Valproate |
|
Slurred Speech |
10 |
Meropenem |
|
Ludwig Angina (Cellulitis) |
11. |
Ticagrelor |
|
Monoparesis |
12. |
Roflumilast |
Reduce the risk of Chronic Obstructive Pulmonary Diseases exacerbations. |
Gynecomastia |
13. |
Clozapine |
Management of Schizophrenic patients. |
Neutropenia |
14. |
Disulfiram |
Alcohol-Abuse Deterrent |
Erythroderma |
15. |
Peginterferon alpha-2a |
Chronic active Hepatitis B & C |
Vasculitis |
16. |
Piperacillin & Tazobacam |
In the treatment of lower RTI/UTI/intra-abdominal infections, skin and skin structure infections, bacterial septicaemia polymicrobic infection |
Vision abnormal |
17. |
Mometasone Furoate, Topical |
Steroid responsive dermatitis , eczema, or atopic dermatitis |
Hypertrichosis/Hirsutism, Skin depigmentation |
18. |
Ranibizumab |
Neovascular Age-Related Macular Degeneration (AMD), Visual impairment due to Diabetic Macular Edema (DME), visual impairment due to Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM).
|
MI |
19. |
Amphotericin B |
Life threatening fungal infections including histoplasmosis, coccidioidomycosis, paracoccidioidomycosis, blastomycosis, aspergillosis, cryptaococcosis, mucormycosis, sporotrichosis and candidiasis; visceral and mucocutaneous leishmaniasis unresponsive to pentavalent antimony compounds; severe meningitis. Perioral candidiasis. |
Bone Marrow Depression |
20.
|
Doxorubicin |
Soft tissue and bone sarcomas, acute leukaemia, malignant lymphoma, Hodgkin’s diseases, breast carcinoma, small cell carcinoma of lungs, AIDS-related Kaposi’s sarcoma, multiple myeloma. Gastrointestinal tract carcinoma, bladder cancer, ovarian carcinoma, acute myeloblastic leukaemia, thyroid carcinoma, neuroblastoma. |
Photosensitivity Reaction |
21. |
Crizotinib |
Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that is Anaplastic Lymphoma Kinase (ALK) – positive. |
Pneumonitis, Hepatic Encephalopathy |
22. |
Febuxostat |
For treatment of chronic hyperuricemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). |
Allergic vasculitis |
23 |
Oxcarbamazepine |
Monotherapy or adjunctive therapy in the treatment of partial seizure, secondary generalized seizure, substitution for Carbamazepine can be made abruptly with an Oxcarbamazepine – to – Carbamazepine ratio of 300:200. |
Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH). |
24 |
Artemether & Lumefantrine |
For treatment of uncomplicated falciparum malaria, mixed infections of falciparum and Chloroquine resistant vivax malaria. |
Stevens- Johnson syndrome/Toxic epidermal necrolysis |
25 |
Cefixime |
Otitis media, respiratory tract infections, uncomplicated UTIs, effective against infections caused by Enterobacteriaceae, H.influenza species. |
Acute generalised exanthematous pustulosis (AGEP) |
26 |
Hepatitis B immune globulin (human) |
Active immunisation against Hepatitis B virus (HBV) infection in subjects considered at risk of exposure to HBV-positive material. |
Encephalopathy |
27 |
Cefotaxime |
Infections due to sensitive gram-positive and gram-negative bacteria such as bacteraemia, cellulitis, Intra-abdominal infections, gonorrhoea, bone or joint infections, skin and skin structure infections, urinary tract infections, septicaemias, surgical prophylaxis, endometritis, life threatening resistant/hospital acquired infections, infections in immune-compromised patients, Haemophilus epiglottitis and meningitis. |
Anaphylactic Shock. |
28 |
Lacosamide |
As an adjunctive treatment of partial onset seizures in patients > 17 years of age. |
Red Man Syndrome |
29 |
Dimethyl fumarate |
For Relapsing remitting multiple sclerosis. |
Osteonecrosis |
30 |
Sodium citrate/Diphenhydramine hydrochloride/Ammonium chloride |
For Symptomatic treatment of cough. |
Myocardial Infraction |
31 |
Cabergoline |
For the treatment of hyperprolactinemia and inhibition of lactation |
Steven Johnson Syndrome |
32 |
Amlodipine |
Angina, hypertension, Coronary artery disease |
Alopecia |
33 |
Nitrofurantoin |
Urinary tract infections; cystitis |
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) |
34 |
Cefoperazone Sulbactam |
For treatment of RTI, UTI (lower & upper), Septicemia, Meningitis, Skin & Soft tissue infection, Endometritis, Other infection of genital tract, Intra-abdominal infection bone & joint infection |
Acute Generalised Exanthematous Pustulosis (AGEP) |
35 |
Cefixime |
Otitis media, respiratory tract infections, uncomplicated UTIs, effective against infections caused by Enterobaceriaceae, H.influenza species. |
Anal Ulcer |
36 |
Atenolol |
Angina and myocardial infarction; arrhythmias; hypertension; migraine prophylaxis |
Dermatitis Lichenoid |
37 |
Olanzapine |
Schizophrenia and other psychotic disorders, mania/mixed episode, psychomotor agitation and violent behaviour |
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) |
38 |
Meropenem |
Nosocomial infections like septicaemia, febrile neutropenia, intraabdominal and pelvic infection etc., caused by cephalosporin’s resistant bacteria, meningitis cystic fibrosis |
Hypokalaemia |
39 |
Montelukast |
Prophylaxis of mild to moderate asthma |
Tinnitus |
40 |
Cefepime |
Cefepime has an extended spectrum of activity against Gram-positive and Gram-negative bacteria, with greater activity against both types of organism than third-generation agents. |
CEFEPIME INDUCED DERMATITIS LICHENOID |